CLINSQUARE: CLINICAL RESEARCH COURSES
Tuesday, February 11, 2025
CLINSQUARE: Clinical Rsearch Courses by LIFEPRONOW
Home Blog Page 117

CDC releases resources to assist states to open

admin
-
0
CDC releases resources to assist states to open

May 20, 2020: “Across America, states and localities are experiencing different phases of the COVID-19 pandemic.

Many have chosen to begin moving gradually and strategically toward resuming civic life.

To help states, tribes, localities, and territories, as well as businesses and community organizations operate as safely as possible during the COVID-19 pandemic, CDC released two new resources to aide in reopening.

The first, CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Againpdf icon, summarizes CDC’s initiatives, activities, and tools in support of the whole-of-government response to COVID-19.

The document includes information on general and healthcare surveillance as well as previously posted guidance on infection control, contact tracing, and testing. 

Additionally, the document includes a standardized way to look at the gating criteria in the Opening Up America Againexternal icon guidance and tools to assist establishments after they open; this is a supplement to the decision trees CDC released May 14.

The second resource is a set of health considerations to be used by summer camps, schools, youth sports organizations, institutes of higher education, and restaurants and bars, that are open.

Considerations documents are concrete, actionable resources that focus on four categories of safeguards:

  • promoting behaviors to reduce spread,
  • maintaining healthy environments,
  • maintaining healthy operations, and
  • preparing for when someone gets sick.

Decisions and strategies about how to operate are implemented at the state, tribal, local, and territorial levels because every locale is different, and individual jurisdictions have the authority and local awareness needed to protect their communities.

CDC is continuing to work with state, tribal, local, and territorial leaders to provide technical assistance, and resources that can help support decisions about how Americans begin to re-engage in civic life while adhering to mitigation strategies such as social distancing, hand-washing and wearing face coverings.”

https://www.cdc.gov/media/releases/2020/s0520-cdc-resources-open.html

CDC Investigation Notice – Salmonella Infections Linked to Live Poultry in Backyard Flocks

admin
-
0
CDC Investigation Notice – Salmonella Infections Linked to Live Poultry in Backyard Flocks
May 20, 2020: “A CDC investigation notice regarding a multistate outbreak of Salmonella infections linked to contact with backyard poultry has been posted.

Importants Points:

  • CDC and public health officials in several states are investigating an outbreak of Salmonella infections linked to contact with live poultry, such as chicks and ducklings, in backyard flocks.
  • There have been 97 ill people reported from 28 states.
  • 17 people have been hospitalized. No deaths have been reported.
  • About one-third of the ill people are children younger than 5 years.
  • People can get sick from Salmonella from touching live poultry or their environment. Birds carrying the bacteria can appear healthy and clean.
  • Spring and summer are always popular times for people to purchase chicks, ducklings, and other live poultry. As people tend to their new flocks, increases in Salmonella infections linked to live poultry are usually reported.
  • Whether you are building your first coop or are a seasoned backyard poultry owner, know the risks of keeping poultry and the simple things you can do to stay healthy.

Tips for backyard flock owners:

  • Always wash hands thoroughly with soap and water right after touching chickens, ducks, or anything in their environment.
  • Don’t let children younger than 5 years touch live poultry. Young kids are more likely to get a severe Salmonella infection.
  • Set aside a pair of shoes to wear while taking care of your birds and keep those outside of your home. Do not wear them inside your house.
  • Don’t let live poultry inside the house. This is especially important in areas where food or drink is prepared, served, or stored, including kitchens and outdoor patios.
  • Don’t kiss or snuggle backyard poultry.

    About Salmonella:
  • Most people infected with Salmonella develop diarrhea, fever, and stomach cramps 6 hours to 6 days after being exposed to the bacteria.
  • The illness usually lasts 4 to 7 days, and most people recover without treatment.
  • In some people, the illness may be so severe that the patient is hospitalized. Salmonella infection may spread from the intestines to the bloodstream and then to other parts of the body.
  • Children younger than 5, adults 65 and older, and people with weakened immune systems are more likely to have severe illness.

If you have questions about cases in a particular state, please call that state’s health department.”

https://www.cdc.gov/media/releases/2020/s0520-salmonella-infections-live-poultry-backyard-flocks.html

HHS Delivers Funding to Expand Testing Capacity for States, Territories, Tribes

admin
-
0
HHS Delivers Funding to Expand Testing Capacity for States, Territories, Tribes

May 18, 2020: “The Department of Health and Human Services (HHS) is delivering $11 billion in new funding to support testing for COVID-19.

The Centers for Disease Control and Prevention (CDC) will provide $10.25 billion to states, territories, and local jurisdictions through CDC’s existing Epidemiology and Laboratory Capacity for Prevention and Control of Emerging Infectious Diseases (ELC) cooperative agreement.

  The Indian Health Service (IHS) will provide $750 million to IHS, tribal, and urban Indian Health programs to expand testing capacity and testing-related activities.

A detailed allocation and distribution methodology will be announced for the IHS funds in the coming days.

This funding is part of the Trump Administration’s broader effort to ensure that states, territories, and tribes have the resources necessary to meet their testing goals as they begin to reopen.

This funding from the Paycheck Protection Program and Health Care Enhancement Act will provide critical support to develop, purchase, administer, process, and analyze COVID-19 tests, conduct surveillance, trace contacts, and related activities.

These funds, along with the previous funding support CDC and IHS provided, will help states, tribes, and territories with their efforts to re-open America.

“This funding secured by President Trump for state, tribal, and local public health activities is a historic investment in America’s ability to track and control the spread of the virus, which is essential to a safe reopening,” said HHS Secretary Alex Azar.

“For the sake of all Americans’ health and well-being, we must help Americans get safely back to work and school, and that requires continued expansion of testing, surveillance, and contact tracing.

The Trump Administration stands ready to support and guide states in their life-saving work to combat the virus and reopen our country.”

“As the Nation cautiously begins the phased approach to reopening, this considerable investment in expanding both testing and contact tracing capacity for states, localities, territories and tribal communities is essential,” said CDC Director Robert R. Redfield, MD.

“Readily accessible testing is a critical component of a four-pronged public health strategy – including rigorous contact tracing, isolation of confirmed cases, and quarantine.

  As communities move toward a blended mitigation and containment strategy, I encourage all Americans to continue to embrace powerful public health measures – social distancing, hand washing and face coverings. We are not defenceless in the battle against this pandemic.”

“These resources will greatly expand testing capacity at federal, tribal, and urban Indian organization facilities throughout the Indian health system,” said IHS Director Rear Adm. Michael Weahkee.

“Testing is critical to our public health response as we work to defeat this pandemic.”

MORE RELATED NEWS: HHS Announces CARES Act Funding Distribution to States and Localities in Support of COVID-19 Response

Each Governor or designee of each State, locality, territory, tribe, or tribal organization receiving funds shall submit to HHS its plan for COVID-19 testing, including goals for the remainder of calendar year 2020, to include:

  • Number of tests needed, month-by-month to include diagnostic, serological, and other tests, as appropriate
  • Month-by-month estimates of laboratory and testing capacity, including related to workforce, equipment and supplies, and available tests
  • Description of how the resources will be used for testing, including easing any COVID-19 community mitigation policies

Jurisdictions will use the funding they receive to meet the testing goals laid out in their COVID-19 testing plans, including purchasing supplies (such as test kits and other testing supplies, as necessary).”

https://www.cdc.gov/media/releases/2020/p0518-hhs-funding-expand-testing-states.html

Historic health assembly ends with global commitment to COVID-19 response

admin
-
0
Historic health assembly ends with global commitment to COVID-19 response

May 19, 2020: “At the meeting of the 73rd World Health Assembly —its first-ever to be held virtually—delegates adopted a landmark resolution to bring the world together to fight the COVID-19 pandemic.

The resolution, co-sponsored by more than 130 countries, was adopted by consensus.

It calls for the intensification of efforts to control the pandemic, and for equitable access to and fair distribution of all essential health technologies and products to combat the virus.

It also calls for an independent and comprehensive evaluation of the global response, including, but not limited to, WHO’s performance.

As WHO convened ministers of health from almost every country in the world, the consistent message throughout the two-day meeting—including from the 14 heads of state participating in the opening and closing sessions —was that global unity is the most powerful tool to combat the outbreak.

The resolution is a concrete manifestation of this call and a roadmap for controlling the outbreak.

In his closing remarks, WHO Director-General Dr Tedros Adhanom Ghebreyesus said “COVID-19 has robbed us of people we love.

It’s robbed us of lives and livelihoods; it’s shaken the foundations of our world; it threatens to tear at the fabric of international cooperation.

But it’s also reminded us that for all our differences, we are one human race, and we are stronger together.”

The World Health Assembly will reconvene later in the year.”
https://www.who.int/news-room/detail/19-05-2020-historic-health-assembly-ends-with-global-commitment-to-covid-19-response

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

admin
-
0
Coronavirus (COVID-19) Update: Daily Roundup May 19, 2020

May 19, 2020: “The U.S. FDA announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • Today, the FDA approved succinylcholine chloride injection USP 200 mg/10 mL, which is indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

    Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia.

    FDA recognizes the increased demand for certain products during the novel coronavirus pandemic and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 104 tests under EUAs, which include 91 molecular tests, 12 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-may-19-2020

Johnson & Johnson Stops Selling Talc-Based Baby Powder In U.S. And Canada

admin
-
0
Johnson & Johnson Stops Selling Talc-Based Baby Powder In U.S. And Canada
May 19, 2020: “Johnson & Johnson will stop selling talcum-based baby powder in the United States and Canada after being ordered to pay out billions of dollars related to lost legal battles over claims the product causes cancer.

The company made the announcement Tuesday. It denied allegations that the powder is responsible for health problems.

“Demand for talc-based Johnson’s Baby Powder in North America has been declining due in large part to changes in consumer habits and fueled by misinformation around the safety of the product and a constant barrage of litigation advertising,” Johnson & Johnson said in a statement.

“From at least 1971 to the early 2000s, the company’s raw talc and finished powders sometimes tested positive for small amounts of asbestos, and that company executives, mine managers, scientists, doctors and lawyers fretted over the problem and how to address it while failing to disclose it to regulators or the public,” Reuters reported.

Asbestos can occur naturally underground near talc.

It becomes harmful when it breaks down and lodges in the lung tissue, possibly leading to diseases including lung cancer, asbestosis and mesothelioma.

Company leaders called the news reports “false and inflammatory.” And on Tuesday, they reiterated denials of the veracity of such claims:

“Decades of scientific studies by medical experts around the world support the safety of our product. We will continue to vigorously defend the product, its safety, and the unfounded allegations against it and the Company in the courtroom. All verdicts against the Company that have been through the appeals process have been overturned.”

In 2018, a St. Louis jury ordered Johnson & Johnson to pay $4.7 billion to 22 women and their families who say the powder contributed to their ovarian cancer.

Last year, a woman in California who says Johnson & Johnson baby powder caused her to develop mesothelioma was awarded $29 million.

The company is appealing the decisions.

Johnson & Johnson faces more than 16,000 talc-related lawsuits nationwide, Reuters reported.

The company’s big moneymakers are no longer its lines of household medicine cabinet brands.

“Fully half of its revenue now comes from pharmaceuticals, used to treat everything from depression to blood clots,” NPR’s Scott Horsley reported.

That has opened up the company to a variety of other massive lawsuits over its role in the nation’s opioid crisis.

Oklahoma, which was the first to take Johnson & Johnson to court in such a case, accused the company of creating a “public nuisance” by oversupplying prescription painkillers.

The state won the case and was eventually awarded $465 million. (The judge had initially ordered a $572 million payout in error.)

Stores around the country and in Canada will continue to sell whatever remaining inventory of baby powder remains on their shelves, the company said.

Additionally, cornstarch-based Johnson’s Baby Powder will remain available in North America.

Both types of the powder will continue to be sold in other countries around the world “where there is significantly higher consumer demand for the product.”

Johnson & Johnson is one of a handful of companies working with the National Institutes of Health to develop potential treatment options for the coronavirus pandemic and a vaccine for COVID-19.”

https://www.npr.org/2020/05/19/859182015/johnson-johnson-stops-selling-talc-based-baby-powder-in-u-s-and-canada

Johnson & Johnson to Provide Webcast Fireside Chat on Clinical Data

admin
-
0
Johnson & Johnson to Provide Webcast Fireside Chat on Clinical Data
May 18, 2020: “The Janssen Pharmaceutical Companies of Johnson & Johnson will participate in a pre-recorded fireside chat webcast hosted by Cantor Fitzgerald focused on clinical data being presented at the virtual 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

The webcast is intended for investors and other interested parties and will be available beginning at 8:00 a.m ET on Tuesday, May 19, 2020.

The webcast will feature Peter F. Lebowitz, MD, PhD, Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC, who will highlight key clinical data including updated results from the Phase 1b/2 CARTITUDE-1 study of the BCMA CAR-T (JNJ-68284528) in relapsed/refractory multiple myeloma, final overall survival results from the ERLEADA® (apalutamide) Phase 3 SPARTAN study in nonmetastatic castration-resistant prostate cancer, an update on Amivantamab (JNJ-61186372, EGFRxcMET bispecific antibody) in patients with exon20ins-mutated non-small cell lung cancer, and initial Phase 1 study results of Teclistamab (JNJ-64007957, BCMAxCD3 bispecific antibody) in relapsed/refractory multiple myeloma. Dr Lebowitz will also discuss the company’s oncology strategy and portfolio.

The webcast can be accessed by visiting the Johnson & Johnson website at www.investor.jnj.com and clicking on “Webcasts/Presentations.” The webcast duration is approximately 30 minutes and will be available through the end of July.”
https://www.jnj.com/johnson-johnson-to-provide-webcast-fireside-chat-on-clinical-data-to-be-presented-at-the-american-society-of-clinical-oncology-and-the-janssen-oncology-strategy-and-portfolio

FDA Clears Phase II COVID-19 Trial of ViralClear’s Merimepodib

admin
-
0
FDA Clears Phase II COVID-19 Trial of ViralClear’s Merimepodib
May 18, 2020: “BioSig Technologies (“BioSig” or the “Company”) and its majority-owned subsidiary, ViralClear Pharmaceuticals, Inc. (ViralClear), announced that the U.S. FDA has completed its review of ViralClear’s IND application.

The FDA informed ViralClear that it may proceed with a proposed phase II study of merimepodib oral solution in adults with COVID-19 who are hospitalized and either require supplemental oxygen or are on non-invasive ventilation or high flow oxygen devices.

This study will be a randomized, double blind, placebo-controlled trial to evaluate the efficacy and safety of merimepodib as an orally administered treatment.

The trial will occur in hospitalized patients who have confirmed infection with SARS-CoV-2 and require supplemental oxygen.

“I’m very pleased to be involved in this planned Phase II study of merimepodib for the treatment of patients with COVID-19 disease,” said Andrew D. Badley, M.D., Professor and Chair of Department of Molecular Medicine and the Enterprise Chair of COVID-19 Task Force.

“We are grateful to the FDA for their prompt response in helping accelerate opportunities to find treatments for the novel coronavirus.

We plan to begin enrollment of this trial as soon as practicable given the importance of finding solutions to this pandemic.”

“FDA clearance for our proposed phase II trial to proceed is an important step for the development of merimepodib,” commented Jerome B. Zeldis, M.D., Ph.D, Executive Chair, co-founder and acting Chief Medical Officer of ViralClear Pharmaceuticals, Inc.

“We intend to conduct Phase II evaluations of our drug both in the hospital and outpatient settings as part of our clinical development plan.”

“We thank the Mayo Clinic for collaborating with us to conduct the trials under the leadership of Professor Badley,” said Nick Spring, Chief Executive Officer of ViralClear Pharmaceuticals, Inc. “Of the therapies that are currently being evaluated as treatments and can be available in the short term, we believe that a broad-spectrum antiviral that is orally administered and widely available could be very helpful in addressing the COVID-19 pandemic.

We further believe it can play a pivotal role in helping manage this type of public health crisis.”


BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals

The Company’s first product, PURE EP(tm) System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Merimepodib, a broad-spectrum anti-viral candidate, that demonstrates strong activity against COVID-19 in cell cultures in laboratory testing and additional antiviral studies are underway.  

Merimepodib was previously in development as a treatment for chronic hepatitis C and psoriasis by Vertex Pharmaceuticals Incorporated (Vertex), with 12 clinical trials conducted (including 315 chronic hepatitis C patients, 24 psoriasis patients, and 98 healthy volunteers) and an extensive preclinical safety package completed.

A manuscript titled, “The IMPDH inhibitor merimepodib provided in combination with the adenosine analogue remdesivir reduces SARS-CoV-2 replication to undetectable levels in vitro”, was submitted to an online peer-reviewed life sciences journal.

This manuscript is authored by Natalya Bukreyeva, Rachel A. Sattler, Emily K. Mantlo, John T. Manning, Cheng Huang and Slobodan Paessler of the UTMB Galveston National Laboratory and Dr Jerome Zeldis of ViralClear Pharmaceuticals, Inc. (“ViralClear”) as a corresponding author.

This article highlights pre-clinical data generated under contract with Galveston National Laboratory at The University of Texas Medical Branch.”

https://www.biosig.com/news-media/press-releases/detail/200/fda-clears-the-investigational-new-drug-application-to

FDA OK’s for Lynparza for metastatic castration-resistant prostate cancer

admin
-
0
FDA OK’s for Lynparza for metastatic castration-resistant prostate cancer

May 20, 2020: “AstraZeneca and MSD announced that Lynparza (olaparib) has been approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

The approval by the US FDA was based on results from the Phase III PROfound trial, which were published in The New England Journal of Medicine.

Prostate cancer is the second-most common cancer in men and despite an increase in the number of available therapies for men with mCRPC, five-year survival remains low.

HRR gene mutations occur in approximately 20-30% of patients with mCRPC.

Maha Hussain, one of the principal investigators of the PROfound trial and deputy director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, said: “Prostate cancer has lagged behind other solid tumours in the era of precision medicine.

I am thrilled by the approval of Lynparza which now brings a molecularly targeted treatment to men with HRR gene-mutated metastatic castration-resistant prostate cancer in the US. The PROfound trial was an international effort and I want to thank the patients, their families, the investigators and their teams involved in making it possible.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “Today marks the first approval for Lynparza in prostate cancer.

In the PROfound trial, Lynparza more than doubled the median radiographic progression-free survival and is the only PARP inhibitor to improve overall survival, versus enzalutamide or abiraterone for men with BRCA or ATM mutations. These results further establish that genomic testing for HRR mutations should be a critical step for the diagnosis and determination of treatment options for men with advanced prostate cancer.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said, “Lynparza is the only PARP inhibitor approved with Phase III data for men with HRR gene-mutated metastatic castration-resistant prostate cancer.

This approval highlights the importance of genomic testing to help identify treatment options for men in this patient population. We are proud to work in collaboration with AstraZeneca toward our overall goal of improving outcomes for patients.”

The primary endpoint of the trial was radiographic progression-free survival (rPFS) in men with BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations. Results showed Lynparza reduced the risk of disease progression or death by 66% (equal to a hazard ratio of 0.34; p-value <0.0001) and improved rPFS to a median of 7.4 months versus 3.6 months with enzalutamide or abiraterone.

Lynparza alsoshowed an rPFS benefit in the overall HRR gene-mutated trial population, a key secondary endpoint, and reduced the risk of disease progression or death by 51% (equal to a hazard ratio of 0.49; p-value <0.0001) and improved rPFS to a median of 5.8 months versus 3.5 months with enzalutamide or abiraterone.

Related News: Lynparza approved in the US as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer

Lynparza demonstrated overall survival benefit in Phase III PROfound trial for BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer

Lynparza recommended by FDA advisory committee for 1st-line maintenance treatment of germline BRCA-mutated metastatic pancreatic cancer, not Progressed on Platinum-Based Chemotherapy

Additional results from the PROfound trial announced on 24 April 2020 demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS) with Lynparza versus enzalutamide or abiraterone in men with mCRPC and BRCA1/2 or ATM gene mutations.

Results showed Lynparza reduced the risk of death by 31% (equal to a hazard ratio of 0.69; p-value=0.0175) and improved OS to a median of 19.0 months versus 14.6 months with enzalutamide or abiraterone.

The full indication is for the treatment of adult patients with deleterious or suspected deleterious germline or somatic HRR gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone. Patients are to be selected for treatment based on an FDA-approved companion diagnostic test for Lynparza.

Lynparza is currently under regulatory review in the EU and other jurisdictions as a treatment for men with HRR gene-mutated mCRPC.

AstraZeneca and MSD are testing Lynparza in additional trials in metastatic prostate cancer including the ongoing Phase III PROpel trial as a 1st-line treatment in combination with abiraterone acetate for patients with mCRPC versus abiraterone acetate alone.

Financial considerations

Following this approval for Lynparza in the US, AstraZeneca will receive a regulatory milestone payment from MSD of $35m, anticipated to be booked as Collaboration Revenue by the Company during the second quarter of 2020.

Metastatic castration-resistant prostate cancer

Prostate cancer is the second-most common cancer in men, with an estimated 1.3 million new cases diagnosed worldwide in 2018 and is associated with a significant mortality rate.1 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.

 mCRPC occurs when prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.

Approximately 10-20% of men with advanced prostate cancer will develop CRPC within five years, and at least 84% of these will have metastases at the time of CRPC diagnosis.

 Of men with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years.3 Despite an increase in the number of available therapies for men with mCRPC, five-year survival remains low.3

HRR gene mutations

HRR gene mutations occur in approximately 20-30% of patients with mCRPC.

 HRR genes allow for accurate repair of damaged DNA in normal cells.

 HRR deficiency (HRD) interferes with normal cell DNA repair mechanisms and can result in normal cell death. This is different in cancer cells, where a mutation in HRR pathways leads to abnormal cell growth and therefore cancer.

The inability to properly repair DNA damage leads to genomic instability and contributes to cancer aetiology.

HRD is a well-documented target for PARP inhibitors, such as Lynparza. PARP inhibitors block a rescue DNA damage repair mechanism by trapping PARP bound to DNA single-strand breaks which leads to replication fork stalling causing their collapse and the generation of DNA double-strand breaks, which in turn lead to cancer cell death.

PROfound

PROfound is a prospective, multicentre, randomised, open-label, Phase III trial testing the efficacy and safety of Lynparza versus enzalutamide or abiraterone in patients with mCRPC who have progressed on prior treatment with enzalutamide or abiraterone and have a qualifying tumour mutation in BRCA1/2, ATM or one of 12 other genes involved in the HRR pathway.

The trial was designed to analyse patients with HRRm genes in two cohorts: the primary endpoint was in those with mutations in BRCA1/2 or ATM genes and then, if Lynparza showed clinical benefit, a formal analysis was performed of the overall trial population of patients with HRRm genes (BRCA1/2, ATM, CDK12 and 11 other HRRm genes; key secondary endpoint).

In the US, patients are selected for treatment with Lynparza based on the following FDA-approved companion diagnostics:

  • FoundationOne CDX: to identify patients with HRR-gene alterations in prostate tumour tissue. FoundationOne is a registered trademark of Foundation Medicine, Inc.
  • BRACAnalysis CDX: a germline test to identify patients with BRCA1 and BRCA2 gene mutations. Myriad Genetics, Inc. owns and commercialises BRACAnalysis CDX.

Lynparza

Lynparza is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair, such as mutations in BRCA1 and/or BRCA2.

Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer.

It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy.

It is also approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. 

Lynparza is approved in the US and several other countries for the treatment of germline BRCA-mutated metastatic pancreatic cancer.

Regulatory reviews are underway in several jurisdictions for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 30,000 patients worldwide. 

Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. 

Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.”
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/lynparza-approved-in-the-us-for-hrr-gene-mutated-metastatic-castration-resistant-prostate-cancer.html

Merk’s Strategic Investments from UPMC Enterprises for Infectious Diseases and Antimicrobial Stewardship

admin
-
0
Merk’s Strategic Investments from UPMC Enterprises for Infectious Diseases and Antimicrobial Stewardship
May 19, 2020: “Merck and UPMC announced that Infectious Disease Connect Inc., a UPMC-backed company offering telemedicine-enabled solutions to hospitals for treatment of infectious diseases, has combined with Merck’s ILÚM Health Solutions, a provider of technology and services to support infectious disease management, clinical decision support and precision antibiotic therapy.

“The addition of ILÚM’s platform and capabilities arms Infectious Disease Connect’s physicians with an important tool to accelerate informed decision-making for the hospitals and patients they serve,” said David Zynn, president of Infectious Disease Connect.

“Combining our respective expertise and resources positions us to enhance the care of patients with infections, optimize antimicrobial therapy, lower costs and reduce the potential for drug resistance.”

As part of this agreement, UPMC Enterprises, the innovation and commercialization arm of UPMC, and Merck Global Health Innovation Fund each are investing $5 million to support the development of customer offerings and business growth for the newly combined entity.

UPMC will retain a majority stake in the combined company.

Infectious Disease Connect has established a telemedicine solution for infectious disease care enabling doctors to access the expertise of an infectious disease specialist to facilitate timely diagnosis and treatment of patients under their care.

With ILÚM’s platform, physicians and pharmacists will receive real-time antimicrobial usage and resistance data from partner hospitals to help them select appropriate therapy, while managing costs, toxicity and the potential for further resistance and transmission of infection.

ILÚM uses machine learning to evaluate a patient’s demographic factors, medication history, past hospitalizations and other data to generate individualized treatment recommendations.

ILÚM also has developed a public health surveillance platform in conjunction with the New York State Department of Health to track and limit the spread of drug-resistant organisms and other infectious disease threats, including COVID-19.

“The rising level of resistance to antimicrobials remains a serious threat to public health, food safety and global security,” said Paul Edwards, chief executive officer, ILÚM.

“This combination marries the excellence of Infectious Disease Connect’s physicians and telemedicine platform with the real-time intelligence needed to effectively manage increasingly complex and life-threatening infectious diseases, as seen in this current pandemic.”

With its expanded capabilities and efficiencies, the new Infectious Disease Connect aims to address the nationwide shortage of infectious disease physicians, the rapidly rising risk of hospital-acquired infections and inappropriate antimicrobial usage, which are estimated to cost hospitals more than $40 billion annually.

The company can provide hospitals with infectious disease expertise and tools to help meet new federal regulations requiring evidence-based antimicrobial stewardship programs that produce measurable results.

Infectious Disease Connect, headquartered in Pittsburgh, will continue to serve ILÚM’s hospital customers and integrate most of its employees.

The expanded company now serves hospitals in nine states.”
https://www.mrknewsroom.com/news-release/corporate-news/%C2%A0infectious-disease-connect-and-ilum-health-solutions-combine-advance-pr

USDA, FDA Strengthen U.S. Food Supply Chain Protections

admin
-
0
USDA, FDA Strengthen U.S. Food Supply Chain Protections

May 19, 2020: “As the COVID-19 pandemic response continues, the U.S. Department of Agriculture and the U.S. Food and Drug Administration have been working around the clock on many fronts to support the U.S. food and agriculture sector so that Americans continue to have access to a safe and robust food supply.

As a next step in carrying out Executive Order 13917, the USDA and FDA today announced a Memorandum of Understanding (MOU) to help prevent interruptions at FDA-regulated food facilities, including fruit and vegetable processing.

This is an important preparedness effort as we are approaching peak harvesting seasons, when many fruits and vegetables grown across the U.S. are sent to be frozen or canned.

The MOU creates a process for the two agencies to make determinations about circumstances in which the USDA could exercise its authority under the Defense Production Act (DPA) with regard to certain domestic food resource facilities that manufacture, process, pack, or hold foods, as well as to those that grow or harvest food that falls within the FDA’s jurisdiction.

While the FDA will continue to work with state and local regulators in a collaborative manner, further action under the DPA may be taken, should it be needed, to ensure the continuity of our food supply.

As needed, the FDA will work in consultation with state, local, tribal and territorial regulatory and public health partners; industry or commodity sector; and other relevant stakeholders (e.g. Centers for Disease Control and Prevention, Occupational Safety and Health Administration) to chart a path toward resuming and/or maintaining operations while keeping employees safe.

We are extremely grateful to essential workers for everything they do every day to keep our pantries, refrigerators and freezers stocked.

All of the food and agriculture sector — whether it is regulated by the USDA or FDA — are considered critical infrastructure, and it is vital for the public health that they continue to operate in accordance with guidelines from the CDC and OSHA regarding worker health and safety.

As we work to get through the current challenge together, we remain committed to workers’ safety, as well as ensuring the availability of foods, and that our food remains among the safest in the world.

Additional Information

On April 28, 2020, President Donald J. Trump signed Executive Order 13917, Delegating Authority Under the Defense Production Act with Respect to the Food Supply Chain Resources During the National Emergency Caused by the Outbreak of COVID-19, delegating the powers of the President under the DPA to the Secretary of Agriculture to ensure continuity of operations for our nation’s food supply chain.

The Executive Order gave the Secretary of Agriculture the authority to utilize the DPA if needed to require the fulfillment of contracts at food processing facilities.

The MOU makes clear that the FDA will work with stakeholders to monitor the food supply for food resources not under the USDA’s exclusive jurisdiction in order to prevent interruptions at FDA-regulated food facilities.

This action is another in a series of proactive steps the USDA and FDA have taken to maximize food availability following unprecedented disruptions the COVID-19 pandemic has caused to food supply chains that have been established and refined for decades.

Supporting Industry and Protecting Frontline Workers

Our nation’s food and agriculture facilities and workers play an integral role in the continuity of our food supply chain.

The USDA and FDA have been working to ensure that frontline workers in food facilities and retailers that have remained on the job during this crisis have the information and resources they need for business continuity and to continue working safely, which includes mitigating the risk of spreading COVID-19. We continue to provide information and update frequently asked questions on both the FDA and USDA’s websites.

We will continue to work with facilities and farms, CDC, OSHA, and state, tribal, and local officials to ensure facilities and farms are implementing practices consistent with federal worker safety guidelines to keep employees safe and continue operations.

We are working with our federal partners who have the authority and expertise over worker safety to develop information on protecting worker health.

We are also working with other federal partners to assist the food and agriculture industry in addressing shortages of personal protective equipment (PPE), cloth face coverings, disinfectants and sanitation supplies.

Monitoring and Securing Human and Animal Food Supply Chains 24/7

Throughout the pandemic, the USDA and FDA have been closely monitoring the food supply chain for shortages in collaboration with industry and our federal and state partners. We are in regular contact with food manufacturers and grocery stores.

We have issued guidance to ensure regulatory flexibility to safely reroute food that typically would be bought in bulk by food facilities and restaurants, like eggs and flour, directly to consumers.

Food Safety Reminders for Every American

As we continue to respond to COVID-19, we want to remind consumers that there is no evidence that COVID-19 has been transmitted by food or food packaging, as well as the importance of taking precautionary food safety steps to protect against foodborne illness pathogens such as Salmonella and E. Coli.

With respect to the safety of food across the U.S., both the USDA and FDA continue to use their respective authorities, including conducting inspections, as appropriate.

The agencies also continue to monitor foods for hazards, work with industry on any potential or reported issues in their facilities, and conduct food recalls when appropriate.

This applies to both domestically produced food and food that is imported from other countries.

Unlike foodborne gastrointestinal (GI) viruses like norovirus and hepatitis A that often make people ill through contaminated food, foodborne exposure is not known to be a route of transmission for SARS-CoV-2, which causes COVID-19.

With respect to foodborne pathogens, the CDC, FDA and FSIS continue to work with state and local partners to investigate foodborne illness and outbreaks.

During this coronavirus outbreak, we will continue to operate to prepare for, coordinate and carry out response activities to incidents of foodborne illness in both human and animal food.”
https://www.fda.gov/news-events/press-announcements/usda-fda-strengthen-us-food-supply-chain-protections

How to Become a Medical Writer in 2020

admin
-
0
How to Become a Medical Writer in 2020
Medical writing is the making of scientific documents by specialized writers.
Generally, a medical writer closely works with scientists, doctors and other subject matter experts in order to create effective documentation that deeply defines research results and product’s usage.

As you already know, Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature, publication articles like journal manuscripts and abstracts, health-related magazines, content for healthcare websites or news articles.

The scientific facts found in such publications have to be interpreted to match the intended audience’s level of understanding, including patients or the general public, physicists or regulators.

 Also, Medical writers require an understanding of the medical concepts and expressions, knowledge of suitable guidelines as regards the structure and contents of specific documents, and good writing skills.

Skills to become a Medical Writer

The basic requirement for becoming a medical writer is off course, familiarity with medical concepts and terminology.

Advanced training in one of the life sciences such as medicine or paramedic sciences such as pharmacy, microbiology, nutrition and dietetics, biochemistry, and biotechnology will have the right context to familiarize the writer with scientific principles and evidence from study.

Other important requirement is the ability to write. Since a medical writer’s basic necessity is to convey science knowledge to the target audience, some degree of command over the language, expressed by the ability to write grammatically correct text, and the ability to simply and succinctly articulate and present knowledge is most critical.

So, in this blog, we are going to understand “what are the various skills required to become a good medical writer?”
Familiarity with medical concepts and terminology is a must before proceeding on the way to become a medical writer.

Others skills that are important to be a medical writer are as follows:

  • Knowledge of Scientific & therapeutic area.
  • The drug development process, pharmacology, drug safety.
  • Statistics. (interpreting or analyzing graphs)
  • Any medical writer has to deal with schemes of randomization, confidence interval, P +values and t-tests.
  • phases (I-IV) of clinical trials.
  • Technical guidelines (ICH guidelines)
  • Knowledge of Scientific & therapeutic area: Since the medical writer publishes information about medical science, it is needless to say that he / she knows the medical terms and principles.

    Someone must also have strong grammatical skills and how to write an argument or description.

    The writing of professional papers relating to particular medical areas, e.g. cardiology or neurology, may be greatly improved by information in this paper.
  • The drug development process, pharmacology, drug safety: Medical writers dealing with the preparation of clinical research and regulatory documents such as trial protocols, investigator brochures, clinical trial results of different phases (I-IV) of clinical trials, effectiveness and safety summaries need a detailed understanding of the drug development cycle, clinical research and various recommendations relating to them.

    Even those writing reports of early clinical development need a good pharmacology framework and an understanding of pharmacokinetic principles.

    Similarly, health writers who write safety papers need to consider the mechanism of drug protection and the protection reporting standards imposed by specific regulators.
  • Statistics: Medical writers come across statistics when they write about the clinical trials and the research studies they write.

    The statistical results of the clinical research must be presented in a way that helps clinicians to determine the consistency and reliability of both the design of the analysis and any conclusions that could impact the clinical practice significantly.

    Meta-analysis is a statistical technique for summarising the results of multiple studies in a quantitative manner

    Any medical writer has to deal with schemes of randomization, confidence interval, P +values and t-tests. Effective medical writing includes an understanding of the facts.

    Another way to know is by conducting conferences on medical statistics provided by qualified statisticians.

    It is very useful for a medical writer to have the knowledge of different statistical methods, but it depends entirely on the type of industry / company in which you work. Yet if you’re able to read or evaluate diagrams, it will be a great benefit in the near future.
  • Technical guidelines: The EU, the USA and Japan have developed a set of common guidelines on the drug development and registration (International Conference on Harmonization [ICH] guidelines).

    ICH Stability Guidelines for Stability Conditions and Testing for Product Quality are followed around the world.

Information about these technical requirements is usually available on the ICH website or websites of the Regulatory Authorities.

Knowledge of these guidelines is a “must” for every medical writer.

In addition, new guidelines emerge, old ones are revised but a medical writer has to keep up to date.

“Publication guidelines like Good Publication Practices, guidelines for reporting clinical trials (e.g. CONSORT), the International Committee of Medical Journal Editors’ (ICMJE) guidelines for manuscripts are available. Moreover, all medical journals have their own instructions for the authors.”

The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ( ICH) is an initiative which brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of the development and registration of pharmaceutical products.

The aim of the ICH is to promote public health through the creation of technical guidelines and specifications for the registration of pharmaceutical products.

The ICH guidelines are divided into the four categories below and ICH topic codes are assigned according to these categories.

Q: Quality Guidelines

“Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for the impurities testing and a more flexible approach to the pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management.

S: Safety Guidelines

ICH has developed a comprehensive set of safety guidelines to identify potential risks such as cancer, genotoxicity and neurotoxicity.

A recent development has been a non-clinical research technique for determining the responsibility for QT interval prolongation: the most significant single cause of drug withdrawals in recent years.

E: Efficacy Guidelines

ICH ‘s research under the heading Efficacy deals with the design, behavior, health and reporting of clinical trials.

It also includes novel types of biotechnological-derived medicines and the use of pharmacogenetics / genomics techniques to develop better-targeted medicines.

M: Multidisciplinary Guidelines

Those are the cross-cutting subjects that do not fall directly into either of the categories of efficiency, health and efficacy.

It includes the ICH medical terminology (MedDRA), the The Technical Document (CTD), and the creation of regulatory knowledge transmission electronic standards (ESTRI).

Among all the ICHGuidelines, Efficacy Guidelines are available on how to write clinical study reports (ICH E3), investigator′s brochures, patient information leaflets, clinical overviews, periodic safety reports (ICH E2C) and other documents required for regulatory submission.

ICH E3: structure and content of clinical report

In November 1995 the ICH Harmonized Guideline was finalized under step 4.

This document describes the format and content of a report on a clinical study that will be acceptable to all ICH Regional regulators.

This consists of a central report suitable for all submissions and appendices that need to be made available but in all cases should not be submitted.

ICH E2C(E2A-E2F): Pharmacovigilance
E2C(R2): Periodic Benefit Risk Evaluation Report

The ICH Harmonised Guideline was finalised under Step 4 in November 1996.

The document includes guidelines on the format and content of security updates, which must be given to regulatory authorities at intervals after goods have been marketed.

The Guideline is intended to ensure that authorities are provided with maximum efficiency and prevent duplication of effort at specified times after promotion, with the worldwide safety experience.

E2F: Development safety update Report

The ICH Harmonised Guideline was finalised under Step 4 in August 2010.

The Development Safety Update Report (DSUR) proposed in this Guideline is intended to serve as a shared standard between the ICH regions for periodic reporting on drugs under clinical (including marketed drugs under further study).

The DSUR’s key focus is on evidence and results from interventional clinical trials (referred to as “clinical trials”) of the examined drugs and biologics, whether or not they have a marketing license.

Upon completion of the E2F Step 4 Guideline, the E2F EWG has produced DSUR Examples for commercial and non-commercial partners to assist with the application of the E2F Guideline.

It should be noted that these documents are the only examples and therefore did not go through the Formal ICH Procedure.

The Periodic Benefit-Risk Evaluation Report described in this Guideline is intended to serve as a common standard for periodic benefit-risk evaluation reports on branded products (approved drugs under further study) between the ICH regions.

This Guideline describes the structure and content suggested for a PBRER, and sets out the points to be included in the planning and presentation.

https://www.ich.org/page/efficacy-guidelines
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149406/
https://journal.emwa.org/statistics/statistics-for-medical-writers/
file:///C:/Users/Rahul/Downloads/mew-253-jacobs.pdfhttps://database.ich.org/sites/default/files/E2C_R2_Guideline.pdf

1...116117118...156Page 117 of 156

EDITOR PICKS

POPULAR POSTS

POPULAR CATEGORY

ABOUT US

LifeProNow provides guidance and high quality contents to help job seekers to get their dream Job. All the contents are written by experienced folks and peer reviewed by experts.

Contact us: [email protected]

FOLLOW US

© LifeProNow | All Rights Reserved