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Difference between Investigator Brochure and Clinical Trial Protocol

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Difference between Investigator Brochure and Clinical Trial Protocol

In simple word, we can say that Investigator Brochure (IB) tells all about investigational product which is in clinical stage of development, whereas clinical trial protocol tells “how to conduct the study with that investigational product

Now lets understand one by one

“Investigator Brochure enables investigators (Doctor at hospital) conducting clinical studies to know the risks and benefits associated with an investigational product.”

What are the components of Investigator Brochure?

 Though it is a quite big document but can be divided in following section:

  • Summary about the all the section of document
  • Introduction include everything about the drug candidate being investigated
  • Details about Physical, chemical, and pharmaceutical properties and formulation of Investiogation drug
  • Preclinical or nonclinical studies information
  • Clinical study related information
  • Any special guidance regarding the use of the drug candidate.

Where I can find the guidelines?

ICH E6 (R2) section 7 provides the information about the structure of this document.

you can read and access the guidelines from the below links:

https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
https://www.ich.org/

When Investigator Brochure is updated?

Ideally It should be updated annually but whenever changes are necessary, it can be updated in the document.

An IB is first required when conducting the first clinical study in human subject and but it is said that it is a living document and need to be updated as the development of drug candidate progress.

Now we understood about IB, then What is clinical trial protocol?

“Clinical trial protocol  describes the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials.”

In simple words, We can say clinical trial protocol tells us “how to conduct scientifically sound, reliable and ethically compliance trials”

What are the components of a clinical trial protocols:

Like a IB it is big document, but can be divided in following section

  • Summary of all the sections i.e title, Name of all the sections, page number, abbreviations, tables etc.
  • Background of the study, Its design, study objectives (questions to be answered), end points (The main result that is measured at the end of a study to see if a given treatment worked)
  • Detailed information about how the data will be collected, recorded, archived (record keeping) and analysed
  • Detailed information about how the safety of the subject is monitored
  • Other information like Ethical consideration, Finance and Insurance policy, publication and reference.

Where I can find the guidelines:

ICH E6 (R2) section 6 provides the information about the structure of this document.

https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf

When clinical trial protocol is updated?:

It is updated whenever there is any change related to conduct of the study in any way.

Most common section which demands to update the clinical trial protocols are collection, recording, analysis, safety section or other ethical reasons.

There is no set frequency for updates.

Investigator brochure and clinical trial protocols are regulatory documents and follow strict guidelines. We have just provided an overview to help freshers to understand two important documents of clinical research before starting in depth readings.

Other important readings for freshers in clinical research:

Clinical Study Report
How to Become a Medical Writer in 2020
Clinical Research Associate: Role, Responsibilities, Skills, and Salary
Beginner’s Guide to Clinical Research Coordinator

Please provide your comments to improve our community.

We recommend the below books for freshers, this is affiliate link, through which our community earns and survive. Reviews are genuine for this book

UK down-schedules Epidyolex to lowest level for controlled drugs

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UK down-schedules Epidyolex to lowest level for controlled drugs
June 24, 2020: “The UK Home Office has reclassified Epidyolex (cannabidiol) as a Schedule 5 drug from its former classification as a Schedule 2 medicine under the Misuse of Drugs Regulations act 2001.

The medicine is approved in the EU for adjunctive therapy of seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients from two years of age and older.

The move to reclassify the drug means that it is now exempt from virtually all controlled drug requirements.

As such, patients and their families will now have greater flexibility on the quantity of medicine they can receive and be able to benefit from repeat prescriptions, whilst healthcare professionals and pharmacists will benefit from reduced controls around the storage and reporting requirements that exist for medicines under Schedule 2, GW noted.

“The decision to move Epidyolex to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole – reducing costs and ensuring the medicine can be dispensed more easily,” said Chris Tovey, the firm’s chief operating officer.

“The extensive preclinical and clinical data that GW developed to support the medicine’s approval by regulatory authorities was pivotal to this important schedule change, and we would like to thank the MHRA, ACMD and Home Office for scrutinising this data and making this change in such a short timeframe.”

“We remain committed to expanding the high-quality evidence base for cannabis-based medicines and securing further regulatory approvals because doing so is in the interests of patients and healthcare professionals and can support further rescheduling.”

http://www.pharmatimes.com/news/uk_home_office_loosens_restrictions_on_gws_epidyolex_1342823

New £1.3m national research programme to evaluate coronavirus tests

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New £1.3m national research programme to evaluate coronavirus tests

June 24, 2020: “Testing for coronavirus infection could become quicker, more convenient and more accurate, following the launch of a multicentre national programme of research that will evaluate how new diagnostic tests perform in hospitals, general practices and care homes.

Determining who has been infected with the novel coronavirus is a key part of the response to the COVID-19 pandemic.

Getting quick and accurate test results when people show symptoms ensures that they receive appropriate care and reduces the chance of the disease being passed on.

The main test currently used to detect coronavirus infection (reverse transcription polymerase chain reaction [RT-PCR]) often involves sending samples away to laboratories, which can take up to 72 hours to provide results.

The life sciences industry has rapidly responded to the pandemic by developing brand new diagnostic tests both to detect current coronavirus infection and to find out if someone has previously been infected.

These new tests – some of which may be able to provide near immediate results at the bedside in hospitals, in GP surgeries or during home visits – have the potential to increase the speed and convenience of testing.

However, many of these new diagnostic tests have yet to be thoroughly evaluated in the settings where they’re likely to be used.

The COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR) – funded by the National Institute for Health Research, UK Research and Innovation, and Asthma UK and British Lung Foundation – will create a single national route for evaluating new diagnostic tests in hospitals and in community healthcare settings.

This programme of research brings together experts who are highly experienced in evaluating diagnostic tests and generating the robust evidence required for a test to be used in the NHS.

Co-primary investigator Professor Gail Hayward, Associate Professor at Oxford University’s Nuffield Department of Primary Care Health Sciences and Deputy Director of the NIHR Community Healthcare MedTech and IVD Co-operative, said: “While a new diagnostic test might work well in a lab under controlled conditions, there are many different factors that could make it less accurate when you take that test out of the lab and into the real world.

These include the range of ways that COVID-19 can present itself, from non-symptomatic carriers to post-symptomatic people who have recovered, the range of other illnesses people might have and the challenges of performing tests in a busy clinical environment.

“Right now there’s a critical gap in how we road-test new diagnostics for COVID-19.

By robustly evaluating these diagnostics in health and care settings, the CONDOR programme will help the government and clinicians to understand the real-world accuracy of these tests in patients presenting with COVID-19 symptoms in the NHS.”

Professor Fiona Watt, Executive Chair of the Medical Research Council, which helped to fund the study, said: “The life sciences industry is developing faster and more accurate SARS-CoV-2 tests, but we need to know if they work as well in the difficulties of real-world settings as they do in a controlled lab environment.

“The CONDOR platform will put the new tests through their paces. The best ones can then be chosen for deployment in healthcare settings, care homes and the community, boosting our ability to detect and control the virus that causes COVID-19.”

Lord Bethell, Minister for Innovation at the Department of Health and Social Care, said: “We need the fastest, most accurate tests in the NHS to help keep COVID-19 under control.

“I’m delighted we’re committing £1.3 million to this brilliant new national research programme, to evaluate how new diagnostic tests perform in health and social care settings – so we can track levels of infection and immunity across the country and help keep people safe.”

The programme is led by Manchester University NHS Foundation Trust, the University of Manchester and the University of Oxford, in collaboration with four NIHR Medtech and In vitro diagnostics Co-operatives (MICs) – NIHR Community Healthcare MIC, NIHR Leeds MIC, NIHR London MIC and the NIHR Newcastle MIC – Manchester University NHS Foundation Trust’s Diagnostics and Technology Accelerator (DiTA), the University of Nottingham, Asthma UK and the British Lung Foundation, and the National Measurement Laboratory, hosted at LGC.

The research team will work with the government and its scientific advisors to identify which new commercially developed diagnostic tests could be most valuable in the NHS.

The effectiveness of these prioritised tests will then be evaluated in a number of possible health and care settings – emergency departments, critical care, acute medical care, primary care, care homes and hospital at home teams.

The research will assess multiple diagnostic tests at once at sites across the country and can be adapted to add in new tests as they become available.

Co-primary investigator Professor Richard Body, Professor of Emergency Medicine at the University of Manchester, Consultant at Manchester University NHS Foundation Trust and Director of DiTA, said: “By validating the accuracy of new clinical tests through CONDOR, we can get novel tests out across the health and care system that are more convenient for patients and get more accurate results. This will mean that patients get better care and we can make more informed, early decisions about how to control spread of the virus.”

One application of CONDOR will be to follow up on patients who test positive with an antibody test, he adds, to find out whether they develop new infections, thus helping to understand whether people with antibodies are immune to reinfection and how long this immunity might last.

Dissemination and national rollout of promising tests will be led by the Academic Health Science Networks in North East and North Cumbria and in Yorkshire and Humber.

The networks have also established a patient and public involvement group to support this project, with over 20 contributors with a wide variety of healthcare experience.

They have already provided helpful insights into concerns about care home diagnostics and ensuring inclusion of samples from black, Asian and minority ethnic groups.

The £1.3 million research programme will also have an analytical validation workstream that will evaluate the accuracy of tests in laboratory settings, a workstream to assess the benefits of these new tests within patient pathways (in collaboration with NICE), and a workstream evaluating the practical suitability and feasibility of tests.

“For example, we’re going to look at tests that use different approaches to collecting samples other than the nose and throat swabs, which are uncomfortable,” said Prof Body. “Some tests in development at the moment measure the virus in saliva, which is much easier and more convenient to collect.”

The partnership with the National Measurement Laboratory, hosted at LGC, enables the independent validation of new molecular point-of-care tests against an international reference measurement procedure and of emerging serological tests against an assay developed using validated antibodies.

This study is one of a number of COVID-19 studies that have been given urgent public health research status by the Department of Health and Social Care, to expedite its delivery in the health and care system.

The research will be supported by the expertise of NIHR MICs, existing teams in NHS organisations and universities that work with companies and specialise in evaluating, and generating high quality evidence on, in vitro diagnostic tests.

Dr Michael Messenger, Deputy Director of the NIHR Leeds MIC and now seconded to the government as a Scientific Advisor to the COVID-19 Testing Programme, said: “We’ve got a wealth of expertise in the NIHR MICs, with Newcastle providing care pathway analysis expertise, the experts in Oxford leading on evaluating tests in community settings, Leeds and Newcastle advising on analytical validation of tests, and London specialising in human factors in diagnostic testing. We’ve also brought in DiTA, which has expertise in evaluating tests in acute care environments.

“The MICs allow us to instantly access a network of experts across the country who specialise in evaluating in vitro diagnostics and provide a valuable infrastructure in the government response to COVID-19.”

Professor George Hanna, Director of the NIHR London MIC at Imperial College that is leading on the human factors issues in test development, said: “CONDOR provides an evaluation route not just for laboratory validity but also for real world use. In the past, the absence of a proper focus on end-user needs has meant that many failures and safety issues have occurred with diagnostics. We can now overcome these barriers by applying our unique human factors approach within CONDOR.”

Dr Ashley Price, Lead for Infection at the NIHR Newcastle MIC, which is leading on the care pathway analysis workstream, said: “The care pathway analysis workstream will map out patients’ journeys with suspected COVID-19, ensuring that the diagnostic tests are evaluated in the most suitable clinical setting, such as hospitals or care homes, and the evidence developed by CONDOR will be appropriate for the practical use of the test.  Working with the National Institute for Health and Care Excellence, we believe this will speed up the delivery of these tests into practice.”

Dr Samantha Walker, Director of Research and Innovation at Asthma UK and British Lung Foundation, said: “We are delighted to be able to support this national research programme in the search to find fast and reliable diagnostic tests for COVID-19. Reducing viral outbreaks through effective testing could help to protect the millions of people in the UK with a lung condition who are more likely to experience severe symptoms.”

https://www.ukri.org/news/national-research-programme-to-evaluate-coronavirus-tests/

Novartis research shows technology talent increasingly drawn to pharma industry since COVID-19

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Novartis research shows technology talent increasingly drawn to pharma industry since COVID-19

June 24, 2020: “According to new research by Novartis, the healthcare and pharma industry has become a more desired career destination for tech talent during the COVID-19 pandemic.

The drug giant has released a global research report, Powerful Pairing, which studied the perception shifts of the tech industry in the wake of the pandemic.

Its research involved 2,502 tech professionals in the US, UK, Germany, China and India, and showed that the two industries they would consider switching to are healthcare and pharma (49% for each).

Also, healthcare and pharma were found to be considerably more attractive than traditional sectors for tech professionals, with only 28% willing to consider the switch to finance and banking or 24% to telecoms.

According to the findings, reasons for the interest in a switch to healthcare and pharma included the opportunity to innovate through tech (52%), improve quality of care and make systems more efficient (49% for each), and to solve real-world problems (48%).

Also of note, the report found that the healthcare and pharma response to COVID-19 has lifted the reputation of the sector amongst tech professionals, with 73% saying that their opinions have improved due to its reaction to the pandemic, and that the application of data science has been a crucial factor in this (85%).

However, it also highlights that while tech professionals want to work in the industry, many fear they lack the knowledge to do so, with 40% reporting they wouldn’t apply to a job in the sector due to their ‘lack of industry knowledge’ and 20% saying they ‘don’t feel qualified to work for a pharma company’.

“COVID-19 has caused a seismic shift in the adoption and scaling of digital technologies in our sector, at a pace never seen before,” said Bertrand Bodson, Chief Digital Officer of Novartis.”

“Our existing investment in core platforms has enabled us to respond rapidly to the needs of patients, physicians and our associates – as well as dial up our work rethinking how we discover and develop new medicines; work smarter; and create better customer experiences. Attracting and nurturing highly sought-after tech talent into the sector is now critical to grasping the clear opportunity that comes with combining the power of data, science and technology.”

https://www.novartis.com/news/novartis-research-shows-technology-talent-increasingly-drawn-pharma-industry-covid-19

Soleno Therapeutics Announces Proposed Public Offering of Common Stock

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Soleno Therapeutics Announces Proposed Public Offering of Common Stock
June 23, 2020: “Soleno Therapeutics announced that it intends to offer and sell shares of its common stock in an underwritten public offering. 

In addition, Soleno intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of its common stock offered in the public offering.

The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Guggenheim Securities, LLC is acting as the sole book-running manager for the offering. 

The securities described above are being offered by Soleno pursuant to a registration statement previously filed with, and declared effective by, the Securities and Exchange Commission (the “SEC”).

A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at [email protected]. 

Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.”

http://investors.soleno.life/news-releases/news-release-details/soleno-therapeutics-announces-proposed-public-offering-common-0

Coronavirus (COVID-19) Update: Daily Roundup June 23, 2020

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Coronavirus (COVID-19) Update: Daily Roundup June 23, 2020

June 23, 2020: “The U.S. Food and Drug Administration announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • In a new FDA Voices, titled FDA maintains the pace of meeting its goals on applications for medical products during the pandemic, FDA Commissioner Stephen M. Hahn, M.D., explains that one of the challenges facing the FDA during the COVID-19 pandemic is how to ensure the timely reviews of medical product applications despite a surge in volume of work and practical constraints that may impact our ability to conduct on-site inspections.

    The FDA has maintained the same pace of meeting its goals on review of applications for medical products during the pandemic that it has maintained in recent years.
  • The FDA is partnering with the Critical Path Institute (C-Path) and the National Institutes of Health’s National Center for Advancing Translational Sciences (NCATS) on the CURE Drug Repurposing Collaboratory (CDRC)External Link Disclaimer.

    CDRC is a forum for the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need, advancing research in these areas.

    Related News: https://lifepronow.com/blog/2020/06/23/coronavirus-covid-19-update-daily-roundup-june-22-2020/

    CDRC will focus on capturing relevant real-world clinical outcome data through the FDA-NCATS CURE ID platform.

    In a pilot project focused on COVID-19, CDRC will use data collected via the CURE ID platform to aggregate global clinician treatment experiences to identify existing drugs that demonstrate possible treatment approaches warranting further study.
  • A Consumer Update, titled Getting Smarter about Food Safety: The Pandemic and Lessons Learned, explains that throughout the COVID-19 pandemic, the experts at the FDA have learned valuable lessons that will help shape our work to create a more digital and transparent, as well as safer, food system for you and your family.

    In the coming weeks, the FDA will unveil the blueprint for the New Era of Smarter Food Safety, which lays out how we will use technology and modern approaches over the next decade to strengthen the ways we approach the safety of the nation’s food supply, every day and in times of crisis.
  • Testing updates:
    • To date, the FDA has authorized 145 tests under EUAs; these include 122 molecular tests, 22 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.”

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-june-23-2020

IMBRUVICA® Seeks to Expand U.S. Label with Long-Term Data in Waldenström’s Macroglobulinemia

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IMBRUVICA® Seeks to Expand U.S. Label with Long-Term Data in Waldenström’s Macroglobulinemia

June 23, 2020: “AbbVie announced that the U.S. FDA will review a supplemental New Drug Application for IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström’s macroglobulinemia (WM), a rare and incurable type of non-Hodgkin’s lymphoma (NHL).

The application seeks to update the IMBRUVICA U.S. Prescribing Information based on analysis of more than five years of data from the Phase 3 iNNOVATE clinical trial.

IMBRUVICA was first approved as a single agent therapy for all lines of WM in 2015, becoming the first and only FDA-approved medicine for WM, administered orally.

In 2018, IMBRUVICA was also approved as the first chemotherapy-free combination treatment with rituximab.

Results from the long-term analysis of the Phase 3 iNNOVATE study will be presented at a future medical congress. As of today, IMBRUVICA is the only Bruton’s tyrosine kinase (BTK) inhibitor approved to treat WM.

“Since IMBRUVICA became the first FDA-approved medicine to treat people living with Waldenström’s macroglobulinemia more than five years ago, it has significantly changed the treatment landscape for this rare and incurable form of non-Hodgkin’s lymphoma,” said Danelle James, M.D., M.A.S., IMBRUVICA Global Development Lead, Pharmacyclics LLC, an AbbVie company.

“This latest submission reinforces how IMBRUVICA has provided an innovative treatment option for WM patients and our commitment to supporting this patient community.”

Related News: Johnson & Johnson and AbbVie Receives 11th FDA Approval for IMBRUVICA® (ibrutinib)

AbbVie to present Ibrutinib (IMBRUVICA®) plus venetoclax (VENCLEXTA®/ VENCLYXTO®) , in American Society of Hematology (ASH) Annual Meeting for the treatment of Leukemias, Lymphomas and Other Blood Cancers

WM typically affects older adults and is primarily found in the bone marrow, although lymph nodes and the spleen may also be affected.

In the U.S., there are about 2,800 new cases of WM each year.1 As of May 2020, the National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) with or without rituximab, as the preferred regimen for patients with WM, including Category 1, Preferred for Primary Therapy for WM.2

“We’ve made significant progress in the treatment of Waldenström’s macroglobulinemia, which until a couple years ago had limited treatment options including chemotherapy,” said Dr. Meletios A.

Dimopoulos, Professor and Chairman of the Department of Clinical Therapeutics, National and Kapodistrian University of Athens School of Medicine, Athens, Greece, and principal investigator.

“The iNNOVATE study continues to deliver strong clinical evidence supporting the long-term use of ibrutinib plus rituximab across first and second lines of therapy for patients with Waldenström’s macroglobulinemia.”

iNNOVATE
iNNOVATE (PCYC-1127) is a Pharmacyclics-sponsored, randomized, placebo-controlled, double-blind, Phase 3 study, which enrolled 150 patients with relapsed/refractory and treatment-naïve Waldenström’s macroglobulinemia.

Patients were randomized to receive intravenous rituximab 375 mg/m2 once weekly for four consecutive weeks, followed by a second four-weekly rituximab course following a three-month interval.

All patients received either ibrutinib 420 mg or placebo once daily continuously until criteria for treatment discontinuation were met.

The primary endpoint was progression-free survival, with secondary endpoints including overall response rate, hematological improvement measured by hemoglobin, time-to-next treatment, overall survival, and number of participants with adverse events as a measure of safety and tolerability within each treatment arm.

IMBRUVICA
IMBRUVICA is a once-daily, first-in-class BTK inhibitor that is administered orally, and is jointly developed and commercialized by Pharmacyclics, LLC, an AbbVie Company, and Janssen Biotech, Inc. (Janssen).

The BTK protein sends important signals that tell B cells to mature and produce antibodies. BTK signaling is needed by specific cancer cells to multiply and spread.

By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.

Since its launch in 2013, IMBRUVICA has received 11 FDA approvals across six disease areas: chronic lymphocytic leukemia (CLL) with or without 17p deletion (del17p); small lymphocytic lymphoma (SLL) with or without del17p; WM; previously-treated patients with mantle cell lymphoma (MCL)*; previously-treated patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy* – and previously-treated patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy.6

IMBRUVICA is now approved in 99 countries and has been used to treat nearly 200,000 patients worldwide across its approved indications.

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD.

IMBRUVICA has been granted four Breakthrough Therapy Designations from the U.S. FDA.

This designation is intended to expedite the development and review of a potential new drug for serious or life-threatening diseases.

IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway.

As of early 2019, the National Comprehensive Cancer Network® (NCCN®), a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education, recommends ibrutinib (IMBRUVICA) as a preferred regimen for the initial treatment of CLL/SLL and it is the only Category 1 treatment for treatment-naïve patients without deletion 17p.

In February 2020, the NCCN Guidelines® were updated to elevate IMBRUVICA with or without rituximab from other recommended regimens to a preferred regimen for the treatment of relapsed/refractory MCL.

IMBRUVICA is being studied alone and in combination with other treatments in several blood and solid tumor cancers and other serious illnesses. IMBRUVICA is the most comprehensively studied BTK inhibitor, with more than 150 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active around the world. For more information, visit www.IMBRUVICA.com.

*Accelerated approval was granted for the MCL and MZL indications based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Side Effect Information

Before taking IMBRUVICA®, tell your healthcare provider about all of your medical conditions, including if you:

  • have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA® for any planned medical, surgical, or dental procedure.
  • have bleeding problems.
  • have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes.
  • have an infection.
  • have liver problems.
  • are pregnant or plan to become pregnant. IMBRUVICA® can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA®. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA®.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA® and for 1 month after the last dose.
    • Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA® and for 1 month after the last dose.
  • are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA® and for 1 week after the last dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA® with certain other medicines may affect how IMBRUVICA® works and can cause side effects.

How should I take IMBRUVICA®?

  • Take IMBRUVICA® exactly as your healthcare provider tells you to take it.
  • Take IMBRUVICA® 1 time a day.
  • Swallow IMBRUVICA® capsules or tablets whole with a glass of water.
  • Do not open, break or chew IMBRUVICA® capsules.
  • Do not cut, crush or chew IMBRUVICA® tablets.
  • Take IMBRUVICA® at about the same time each day.
  • If you miss a dose of IMBRUVICA® take it as soon as you remember on the same day. Take your next dose of IMBRUVICA® at your regular time on the next day. Do not take extra doses of IMBRUVICA® to make up for a missed dose.
  • If you take too much IMBRUVICA® call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking IMBRUVICA®?

  • You should not drink grapefruit juice, eat grapefruit, or eat Seville oranges (often used in marmalades) during treatment with IMBRUVICA®. These products may increase the amount of IMBRUVICA® in your blood.

What are the possible side effects of IMBRUVICA®?

IMBRUVICA® may cause serious side effects, including:

  • Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA®, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache. 
  • Infections can happen during treatment with IMBRUVICA®.  These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA®.
  • Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA®, but can also be severe.  Your healthcare provider should do monthly blood tests to check your blood counts.
  • Heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter). Serious heart rhythm problems and death have happened in people treated with IMBRUVICA®, especially in people who have an increased risk for heart disease, have an infection, or who have had heart rhythm problems in the past. Tell your healthcare provider if you get any symptoms of heart rhythm problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, chest discomfort, or you faint.  If you develop any of these symptoms, your healthcare provider may do a test to check your heart (ECG) and may change your IMBRUVICA® dose.
  • High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA®. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
  • Second primary cancers. New cancers have happened during treatment with IMBRUVICA®, including cancers of the skin or other organs.
  • Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.

The most common side effects of IMBRUVICA® in adults with B-cell malignancies (MCL, CLL/SLL, WM and MZL) include:

  • diarrhea
  • tiredness
  • muscle and bone pain
  • rash
  • bruising

The most common side effects of IMBRUVICA® in adults with cGVHD include:

  • tiredness
  • bruising
  • diarrhea
  • mouth sores (stomatitis)
  • muscle spasms
  • nausea
  • pneumonia

Diarrhea is a common side effect in people who take IMBRUVICA®. Drink plenty of fluids during treatment with IMBRUVICA® to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.

These are not all the possible side effects of IMBRUVICA®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.”

https://news.abbvie.com/news/press-releases/imbruvica-ibrutinib-seeks-to-expand-us-label-with-long-term-data-in-waldenstrms-macroglobulinemia-wm.htm

Gilead Sciences Secures Exclusive Option to Acquire Pionyr Immunotherapeutics

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Gilead Sciences Secures Exclusive Option to Acquire Pionyr Immunotherapeutics
June 23, 2020: “Gilead Sciences, Inc. announced that for $275 million the company will acquire a 49.9 percent equity interest in Pionyr Immunotherapeutics Inc., a privately held company developing first-in-class cancer immunotherapies, and an exclusive option to purchase the remainder of Pionyr.

Under the agreement, Pionyr’s shareholders may receive up to an additional $1.47 billion in option exercise fees and future milestone payments.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200623005314/en/

Pionyr’s Myeloid Tuning™ therapies have the potential to treat patients who currently do not benefit from checkpoint inhibitor therapies.

PY314 and PY159 have demonstrated preclinical efficacy, suggesting potential in solid tumors in combination with established anti-PD(L)-1 agents.

Pionyr plans to file investigational new drug (IND) applications with the U.S. Food and Drug Administration for both PY314 and PY159 in the third quarter of this year.

Pending Phase 1b results from either candidate – or sooner if Gilead chooses – Gilead can exercise its exclusive option to acquire the remainder of Pionyr.

“Pionyr is pursuing promising, novel biology in the field of immuno-oncology,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.

“The agreement represents important progress as we continue to build out Gilead’s presence in immuno-oncology with innovative and complementary approaches. We look forward to seeing the programs advance with the goal of developing new therapies that will improve the treatment of cancer.”

“This agreement underscores the value of our myeloid tuning platform and the potential of our pipeline of antibody therapeutics designed to turbocharge the immune system within the tumor microenvironment,” said Steven P. James, President and Chief Executive Officer, Pionyr.

“PY314 and PY159 are first-in-class antibodies designed to remove or reprogram, respectively, the immune suppressive cells in the tumor microenvironment and thereby enhance anti-tumor immunity.

We are grateful that Gilead has acknowledged the promise of this transformational approach to potentially benefit patients across a range of solid tumors.”

Terms of the Agreement

Under the terms of the agreement, Pionyr’s shareholders will receive $275 million upon closing. Gilead will receive 49.9 percent of the common stock of Pionyr and an exclusive option to purchase the remaining equity.

Gilead may exercise its exclusive option upon completion of Phase 1b studies for PY314 and PY159, or at an earlier time if Gilead chooses to do so, for a $315 million option exercise fee and up to $1.15 billion in potential future milestone payments.

In addition, Gilead will provide Pionyr with additional funding for the PY314 and PY159 clinical programs, as well as ongoing research and development programs.

The transaction is subject to customary closing conditions and is expected to close shortly.

Gilead will have the right to nominate one individual to Pionyr’s Board of Directors upon closing of the transaction.

In addition, Gilead and the other stockholders of Pionyr will jointly select and nominate one independent individual to Pionyr’s Board of Directors.

BofA Securities is acting as financial advisor to Gilead. Centerview Partners LLC is acting as financial advisor to Pionyr.

Myeloid Tuning

Pionyr has developed a research approach called Myeloid Tuning, which is designed to rebalance the tumor microenvironment (TME) to promote anti-tumor immunity.

Myeloid cells are a family of cell types that play an important role in both the activation and in the suppression of immune response to cancer.

PY314 targets TREM2, a protein commonly found on the surface of a certain type of immunosuppressive, pro-tumor myeloid cells. PY314 is designed to selectively deplete these cells, resulting in a rebalancing of the tumor microenvironment that favors anti-tumor immunity.

PY159 targets TREM1, a protein that is expressed on multiple immunosuppressive myeloid cells such as macrophages, neutrophils and myeloid derived suppressor cells.

PY159 is designed to reprogram these immunosuppressive cells to instead stimulate a pro-inflammatory, anti-tumor immune response.”

https://www.gilead.com/news-and-press/press-room/press-releases/2020/6/gilead-sciences-secures-exclusive-option-to-acquire-pionyr-immunotherapeutics

Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas

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Sanofi and Translate Bio expand collaboration to develop mRNA vaccines across all infectious disease areas
June 23, 2020: “Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, have agreed to expand their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases.

The expansion of this agreement will further unite Translate Bio’s expertise and knowledge from more than 10 years of mRNA research and development with Sanofi’s leadership in vaccine research and development.

Under the expansion agreement, Translate Bio will receive a total upfront payment of $425 million, consisting of a $300 million cash payment and a private placement common stock investment of $125 million at $25.59 per share representing a 50 percent premium to the 20-day moving average share price prior to signing.

Translate Bio will also be eligible for potential future milestones and other payments up to $1.9 billion, including $450 million of milestones under the 2018 agreement. Of these potential milestones and other payments, approximately $360 million are anticipated over the next several years, inclusive of COVID-19 vaccine development milestones.

In addition, Translate Bio is also eligible to receive tiered royalty payments based upon worldwide sales of the developed vaccines.

Sanofi Pasteur will pay for all costs during the collaboration term. Under this agreement Sanofi Pasteur will receive exclusive worldwide rights for infectious disease vaccines.

“As all eyes are on prevention of infectious disease through vaccines, this is a pointed moment in time where we are called upon to seek innovative ways to protect public health,” said Thomas Triomphe, Executive Vice President, Sanofi Pasteur. 

“We are excited by the novel technology and expertise Translate Bio brings, and we believe that adding this mRNA platform to our vaccines development capabilities will help us advance prevention against current and future infectious diseases.”

“The expansion of our collaboration with Sanofi Pasteur validates the progress we’ve made in the development of mRNA vaccines for infectious diseases since our work together began in 2018 and also speaks to the potential of our mRNA platform.

We are excited to work with Sanofi in this broadened capacity with the goal of ultimately delivering vaccines on a global scale, a need underscored by the current pandemic,” said Ronald Renaud, Chief Executive Officer of Translate Bio.

“Translate Bio will also be well positioned financially to continue to build upon our internal capabilities with a focus on advancing innovations in platform discovery and on the development of ongoing and additional preclinical therapeutic programs as we aim to bring multiple programs towards clinical development.”

Under the collaboration, Translate Bio is using its mRNA platform to discover, design and manufacture vaccine candidates and Sanofi Pasteur is providing its deep vaccine expertise to advance vaccine candidates into and through further development.

Translate Bio will also transfer technology and processes to allow Sanofi Pasteur to develop and manufacture mRNA vaccines for infectious diseases.

The teams are currently evaluating multiple COVID-19 vaccine candidates in vivo for immunogenicity and neutralizing antibody activity to support lead candidate selection and the companies have the goal of initiating a first-in-human clinical trial in the fourth quarter of 2020.

The companies are also advancing an mRNA vaccine development candidate against influenza through preclinical studies with clinical trial initiation anticipated in mid-year 2021.

Additional mRNA vaccine development programs under the collaboration include another viral pathogen and a bacterial pathogen.

The transactions, including the equity sale, are subject to customary closing conditions, including termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act.

For more information regarding the financial and other terms of the agreement, please refer to the Current Report on Form 8-K which will be filed by Translate Bio with the U.S. Securities & Exchange Commission on June 23, 2020.

Evercore acted as financial advisor to Translate Bio for the expansion of the collaboration agreement.

mRNA Vaccines 
Vaccines work by mimicking disease agents to stimulate the immune system; building up a defense mechanism that remains active in the body to fight future infections.

mRNA vaccines offer an innovative approach by delivering a nucleotide sequence encoding the antigen or antigens selected for their high potential to induce a protective immune response.

mRNA vaccines also represent a potentially innovative alternative to conventional vaccine approaches for several reasons – their high potency, ability to initiate protein production without the need for nuclear entry, capacity for rapid development and potential for low-cost manufacture and safe administration using non-viral delivery.

This approach potentially enables the development of vaccines for disease areas where vaccination is not a viable option today.

Additionally, a desired antigen or multiple antigens can be expressed from mRNA without the need to adjust the production process offering maximum flexibility and efficiency in development.

Sanofi Pasteur and Translate Bio collaboration
In 2018, Translate Bio entered into a collaboration and exclusive license agreement with Sanofi Pasteur Inc., the vaccines global business unit of Sanofi, to develop mRNA vaccines for up to five infectious disease pathogens.

This agreement was first expanded in March 2020 to include the collaborative development of a novel mRNA vaccine for COVID-19.

This collaboration brings together Sanofi Pasteur’s leadership in vaccines and Translate Bio’s mRNA research and development expertise.

Under the agreement, the companies are jointly conducting research and development activities to advance mRNA vaccines and mRNA vaccine platform development during a research term of at least four years after the original signing in 2018.

Translate Bio and Sanofi Pasteur have advanced the preclinical development vaccine programs including screening, optimization and production of mRNA and LNP formulations across multiple targets.

Translate Bio
Translate Bio is a clinical-stage mRNA therapeutics company developing a new class of potentially transformative medicines to treat diseases caused by protein or gene dysfunction. 

Translate Bio is primarily focused on applying its technology to treat pulmonary diseases caused by insufficient protein production or where the reduction of proteins can modify disease.

Translate Bio’s lead mRNA therapeutic program is being developed as a treatment for cystic fibrosis (CF) and is in a Phase 1/2 clinical trial. The Company also believes its technology is applicable to a broad range of diseases, including diseases that affect the liver.

Additionally, the platform may be applied to various classes of treatments, such as therapeutic antibodies or vaccines in areas such as infectious disease and oncology. For more information about the Company, please visit www.translate.bio or on Twitter at @TranslateBio.”

http://www.globenewswire.com/news-release/2020/06/23/2051681/0/en/Sanofi-and-Translate-Bio-expand-collaboration-to-develop-mRNA-vaccines-across-all-infectious-disease-areas.html?print=1 

EUROPEAN MEDICINES AGENCY VALIDATES APPLICATION FOR BAVENCIO® for UROTHELIAL CARCINOMA

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EUROPEAN MEDICINES AGENCY VALIDATES APPLICATION FOR BAVENCIO® for UROTHELIAL CARCINOMA
June 22, 2020: “Merck and Pfizer Inc. announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO® (avelumab) for first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC).

With this validation, the application is complete, and the EMA will now begin the review procedure.

The application is based on results from the Phase III JAVELIN Bladder 100 study which showed a statistically significant improvement in overall survival (OS) for BAVENCIO plus best supportive care (BSC) as first-line maintenance treatment following induction chemotherapy versus BSC alone in patients with locally advanced or metastatic UC.

The data were presented at the ASCO 2020 Virtual Scientific Meeting.

In the European Union alone, nearly 200,000 people are diagnosed each year with bladder cancer.

Urothelial carcinoma accounts for approximately 90 percent of bladder cancers.

Urothelial carcinoma becomes harder to treat as it advances, spreading through the layers of the bladder wall.

Despite available therapies, more than 60,000 Europeans die from bladder cancer each year.

Earlier this year, the US Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for first-line maintenance treatment of patients with locally advanced or metastatic UC for Priority Review under the agency’s Real-Time Oncology Review (RTOR) pilot program.

Related News: BAVENCIO (avelumab) extensively Improved Overall Survival in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

The FDA also granted Breakthrough Therapy Designation to BAVENCIO for this indication.

In addition, a supplemental new drug application has also been accepted by Japan’s Ministry of Health, Labour and Welfare for BAVENCIO as a first-line maintenance therapy for locally advanced or metastatic UC.

JAVELIN BLADDER 100

JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC.

A total of 700 patients whose disease had not progressed after platinum-based induction chemotherapy as per RECIST v1.1 were randomly assigned to receive either BAVENCIO plus BSC or BSC alone.

The primary endpoint was OS in the two primary populations of all patients and patients with PD-L1+ tumors defined by the Ventana SP263 assay.

BAVENCIO® (AVELUMAB)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions.

By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.

In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications in the US

BAVENCIO® (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved Label

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging.

Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis.

Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

  • BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy.

    Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity.

    Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade 3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution.

Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

  • Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation.

    Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.
  • Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade ≥3) hyperglycemia, and resume treatment when metabolic control is achieved.

    Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment.

Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower.

Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation.

For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes.

Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate.

Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper.

Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barré syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions.

Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions.

Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions.

Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction.

Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events.

MACE occurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death.

Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk.

Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, ≥ 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, ≥ 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, ≥ 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, ≥ 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, ≥20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, ≥20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

Merck KGaA, Darmstadt, Germany-Pfizer Alliance

Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer.

The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany.

The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.

https://www.pfizer.com/news/press-release/press-release-detail/european-medicines-agency-validates-application-bavencior

PFIZER ANNOUNCES START OF FOUR PHASE 3 CLINICAL TRIALS FOR INVESTIGATIONAL VACCINES

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PFIZER ANNOUNCES START OF FOUR PHASE 3 CLINICAL TRIALS FOR INVESTIGATIONAL VACCINES

June 22, 2020: “Pfizer Inc. announced the initiation of four Phase 3 clinical trials within its current pipeline of investigational vaccines:

  • Two studies (NCT04382326 and NCT04379713) of the 20-valent pneumococcal polysaccharide conjugate vaccine candidate, 20vPnC, evaluating a four-dose series in infants starting at 2 months of age.

    Both studies will expand the data on the safety and tolerability of the investigational vaccine in infants and include a control group of Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]).

    Study NCT04382326 has the goal of determining immunologic noninferiority between 20vPnC and Prevnar 13®, a critical requirement for vaccine licensure.
  • One study (NCT04424316) of the respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, in pregnant women to evaluate the safety and efficacy of RSVpreF in infants born to immunized pregnant women as compared to placebo.
  • One study (NCT04440163) of the pentavalent meningococcal vaccine candidate, MenABCWY, in adolescents and young adults to assess the safety, tolerability, and immunogenicity of the MenABCWY vaccine candidate compared to licensed meningococcal vaccines, with the goal of determining immunologic noninferiority.

“The start of four Phase 3 studies across our portfolio of investigational vaccines is a testament to the talented and dedicated colleagues working throughout Pfizer, and the continued commitment to unlock the potential promise and value that vaccines hold for our world,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc.

“If approved, all three vaccine candidates could help prevent serious, possibly deadly infectious diseases that negatively impact millions of people of all ages globally.”

20vPnC Pediatric
Approximately 3,500 infants will be enrolled in total for these two studies. In both studies, infants will be vaccinated with either 20vPnC or Prevnar 13® (13vPnC) at 2, 4, 6, and 12-15 months of age, along with other routine infant vaccines according to the current CDC recommended schedule.

Additional information can be found at www.clinicaltrials.gov under the identifiers NCT04382326 and NCT04379713. The results of the descriptive Phase 2 infant study with 20vPnC (NCT03512288) have been submitted for presentation at ID Week 2020.

In May 2017 the FDA granted Fast Track status for a pediatric indication for 20vPnC.

Global Burden of Pneumococcal Disease
Pfizer’s 20vPnC vaccine candidate includes 13 serotypes already included in Prevnar 13® (13vPnC). Together, the 20 serotypes included in 20vPnC are responsible for the majority of currently circulating pneumococcal disease in the U.S. and globally.

RSVpreF
The Phase 3 trial of RSVpreF is a global, double-blind, placebo-controlled study that will enroll 6,900 pregnant women ages 18 through 49 and their infants.

Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT04424316.

In April 2020, positive top-line results were achieved for a Phase 2b proof-of-concept study of RSVpreF, which evaluated the safety, tolerability and immunogenicity of RSVpreF in vaccinated pregnant women ages 18 through 49 and their infants.

Detailed results from the study will be shared at a future medical conference.

In November 2018, the FDA granted Fast Track status to RSVpreF for prevention of RSV-associated lower respiratory tract illness in infants by active immunization of pregnant women.

Global Burden of RSV
RSV is a virus that can cause severe respiratory disease in infants and older adults.

Globally, there are an estimated 33 million cases of RSV annually in children less than 5 years of age, with about 3 million hospitalized and approximately 120,000 dying each year from complications associated with the infection.

Nearly half of these pediatric hospitalizations and deaths occur in infants less than 6 months of age.

The medical community is limited to offering only supportive care for those with the illness.

MenABCWY
The Phase 3 trial will enroll approximately 2,413 adolescents and young adults (10 through 25 years of age) from the United States and Europe. Additional information about the study can be found at www.clinicaltrials.gov under the identifier NCT04440163.

Initiation of the Phase 3 trial is based on positive results from a proof-of-concept study (NCT03135834) in 543 adolescents and young adults.

Detailed results from the proof-of-concept study have been submitted for presentation at ID Week 2020.

Pfizer’s pentavalent meningococcal vaccine candidate combines its two approved meningococcal vaccines, Nimenrix™ (meningococcal group A, C, W-135, and Y conjugate vaccine) and Trumenba® (meningococcal group B vaccine). Approvals of Nimenrix™ and Trumenba® vary by country.

Global Burden of Meningococcal Disease
Meningococcal disease is an uncommon but serious disease that can attack without warning and lead to meningitis and serious blood infections.

The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis groups (A, B, C, W and Y).

 Together, these meningococcal groups account for 96% of all invasive meningococcal disease (IMD), with group B accounting for the majority of disease in adolescents and young adults in the U.S. and Europe.

INDICATIONS FOR PREVNAR 13®

  • Prevnar 13® is a vaccine approved for adults 18 years and older for the prevention of pneumococcal pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F
  • Prevnar 13® is also approved for children 6 weeks through 17 years of age (prior to the 18th birthday) for the prevention of invasive disease caused by the 13 strains of Streptococcus pneumoniae in the vaccine, and for children 6 weeks through 5 years (prior to the 6th birthday) for the prevention of ear infections caused by 7 of the 13 strains in the vaccine
  • Prevnar 13® is not 100% effective and will only help protect against the 13 strains in the vaccine

IMPORTANT SAFETY INFORMATION

  • Prevnar 13® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine
  • Children and adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response
  • In adults, the most common side effects were pain, redness, and swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, vomiting, fever, chills, and rash
  • A temporary pause of breathing following vaccination has been observed in some infants born prematurely
  • The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
  • In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
  • Ask your healthcare provider about the risks and benefits of Prevnar 13®. Only a healthcare provider can decide if Prevnar 13® is right for you or your child

INDICATION FOR TRUMENBA® IN THE U.S.

  • Trumenba® is a vaccine indicated for individuals 10 through 25 years of age for active immunization to prevent invasive disease caused by Neisseria meningitidis group B
  • The effectiveness of the two-dose schedule of Trumenba® against diverse N. meningitidis group B strains has not been confirmed

IMPORTANT SAFETY INFORMATION

  • Trumenba® should not be given to anyone with a history of a severe allergic reaction after a previous dose of Trumenba
  • Some individuals with weakened immune systems may have a reduced immune response
  • Persons with certain complement deficiencies and persons receiving treatments such as Soliris® (eculizumab), are at increased risk for invasive disease caused by Neisseria meningitidis group B even with receipt of vaccination with Trumenba®
  • As with any vaccine, vaccination with Trumenba® may not protect all vaccine recipients against N. meningitidis group B infections
  • Fainting can occur in association with administration of injectable vaccines, including Trumenba
  • The most common adverse reactions in adolescents and young adults were pain at injection site, fatigue, headache, and muscle pain. Nausea was reported in adolescents in early phase studies
  • Data are not available on the safety and effectiveness of using Trumenba® and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • Tell your health care provider if you are pregnant, or plan to become pregnant
  • Ask your health care provider about the risks and benefits of Trumenba®. Only a health care provider can decide if Trumenba® is right for you or your child

INDICATION FOR NIMENRIX™ IN THE E.U.

  • Nimenrix™ is a vaccine indicated for individuals six weeks of age and older for active immunization to prevent invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y

IMPORTANT SAFETY INFORMATION

  • Nimenrix™ should not be given to anyone with a history of a severe allergic reaction after a previous dose of Nimenrix™
  • Some individuals with weakened immune systems may have a reduced immune response
  • Persons with certain complement deficiencies and persons receiving treatments such as Soliris® (eculizumab), are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W, and Y, even with receipt of vaccination with Nimenrix™
  • As with any vaccine, vaccination with Nimenrix™ may not protect all vaccine recipients against N. meningitidis groups A, C, W and Y
  • Fainting can occur shortly before or after injecting vaccines, including Nimenrix™
  • The most common adverse reactions were loss of appetite, irritability, drowsiness, headache, fatigue, fever, and pain, redness, and swelling at the injection site
  • Tell your healthcare provider if you are pregnant, or plan to become pregnant
  • Ask your healthcare provider about the risks and benefits of Nimenrix™. Only a healthcare provider can decide if Nimenrix™ is right for you or your child

Pfizer Inc: Breakthroughs that change patients’ lives

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https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-start-four-phase-3-clinical-trials

Coronil: ICMR, AYUSH Ministry distance themselves from Patanjali’s cure for coronavirus

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Coronil: ICMR, AYUSH Ministry distance themselves from Patanjali’s cure for coronavirus

June 23, 2020: “As per India Today Indian Council of Medical Research and AYUSH Ministry have distanced themselves from Patanjali’s cure for coronavirus Coronil.

Yoga Guru Baba Ramdev on Tuesday claimed that Patanjali Research Institute has invented coronil – an ayurvedic cure for novel coronavirus. At a press conference held at Patanjali headquarter in Haridwar, Ramdev said that Coronil has been tested in a randomised placebo-controlled clinical trial on Covid-19 patients.

“We conducted a clinical case study and clinical controlled trial, and found 69 per cent patients recovered in three days and 100 per cent patients recovered in seven days,” Ramdev said.

The Yoga guru claimed that coronil was the first Ayurvedic-clinically controlled, research, evidence and trial based medicine for Covid-19. The research was conducted in collaboration with the National Institute of Medical Science, Jaipur.

However, ICMR, which is the apex medical body and nodal agency for the Covid-19 treatment in India, has declined to be associated with the new medicine. When asked about coronil, ICMR officials said that they do not deal with ayurvedic medicines, AYUSH Ministry does.

When the queries on coronil were directed at AYUSH Ministry officials, they first said ICMR officials will give details regarding the new medicine. When we informed them of the ICMR response, the ministry officials said that the state government, in this case, Uttarakhand government, was responsible for granting a license to a pharma firm, including Ayurvedic drug manufacturer.

According to top sources in Patanjali, coronil has received a license as a medicine. “It contains salts and herbs suggested by AYUSH Ministry. Allopaths call these salts as anti-viral, whereas Ayurved knows them as immunity boosters,” the sources said.”
https://www.indiatoday.in/india/story/coronil-icmr-ayush-ministry-distance-themselves-from-patanjali-s-cure-for-coronavirus-1691936-2020-06-23

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