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Acquisition of Neogene Therapeutics completed

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Acquisition of Neogene Therapeutics completed

January 16, 2023: “AstraZeneca has completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts).

Neogene will operate as a wholly owned subsidiary of AstraZeneca, with operations in Amsterdam, the Netherlands and California, US.

Financial considerations
AstraZeneca has acquired all outstanding equity of Neogene in exchange for an initial payment of $200m.

Under the terms of the agreement, AstraZeneca will pay up to $120m in additional contingent milestone-based and non-contingent consideration.

https://www.astrazeneca.com/media-centre/press-releases/2023/acquisition-of-neogene-therapeutics-completed.html

Acquisition of Neogene Therapeutics completed

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Acquisition of Neogene Therapeutics completed

January 16, 2023: “AstraZeneca has completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts).

Neogene will operate as a wholly owned subsidiary of AstraZeneca, with operations in Amsterdam, the Netherlands and California, US.

Financial considerations
AstraZeneca has acquired all outstanding equity of Neogene in exchange for an initial payment of $200m.

Under the terms of the agreement, AstraZeneca will pay up to $120m in additional contingent milestone-based and non-contingent consideration.

https://www.astrazeneca.com/media-centre/press-releases/2023/acquisition-of-neogene-therapeutics-completed.html

Bayer to Accelerate Drug Discovery with Google Cloud’s High-Performance Compute Power

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Bayer to Accelerate Drug Discovery with Google Cloud’s High-Performance Compute Power

January11,2023: “Bayer AG and Google Cloud today announced a collaboration to drive early drug discovery that will apply Google Cloud’s Tensor Processing Units (TPUs), which are custom-developed accelerators designed to run cutting-edge machine learning models and computationally-intensive workloads, to help accelerate and scale Bayer’s quantum chemistry calculations.

The theory of quantum mechanics applied to computer-aided drug discovery enables the in-silico modeling of biological and chemical systems with high accuracy, and therefore has the potential to help identify novel drug candidates.

The objectives of the collaboration are to accelerate and scale quantum chemistry calculations using Google Cloud’s TPUs and to demonstrate fully quantum mechanical modeling of protein-ligand interactions.

The results will determine the scientific and economic viability of large-scale density functional theory calculations for practical applications.

“Bayer’s aspiration to be among the leading innovators drives us to continue to invest in novel and disruptive technologies to solve complex problems,” said Bijoy Sagar, Chief Information and Digital Transformation Officer at Bayer AG.

“Partnering with Google Cloud on TPU powered quantum chemistry complements our ambition to work with industry leaders and experts to quickly deliver on digital transformation.”

“Accelerating drug discovery may be one of the most important applications for AI and high performance computing in the healthcare industry,” said Thomas Kurian, CEO of Google Cloud.

“Bringing Bayer’s powerful research and development capabilities together with our industry-leading infrastructure has the potential to unlock new discoveries – with greater accuracy and speed – helping to get medicines to patients faster.”

Increasing R&D efficiency to accelerate development of impactful medicines for patients in need is central to Bayer’s innovation strategy.

“By combining Google Cloud’s computing power with Bayer’s leading expertise in drug discovery we intend to unleash the potential of large-scale quantum chemistry,” said Marianne De Backer, Head of Strategy, Business Development & Licensing/Open Innovation and Member of the Executive Committee, Pharmaceuticals Division at Bayer AG.

“Working with industry leaders and pioneers to leverage scientific advancements fueled by digital innovations is essential to the present and future of patient care.”

https://www.bayer.com/media/en-us/bayer-to-accelerate-drug-discovery-with-google-clouds-high-performance-compute-power/

AZ’s Tezspire approved for self-administration in EU for severe asthma

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AZ’s Tezspire approved for self-administration in EU for severe asthma

January 13, 2023: “AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.

The CHMP opinion can be implemented without the need for a European Commission decision due to the nature of the Type-II label variation.

The approval for self-administration was based on results from the PATHFINDER clinical trial programme, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trial.

The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home throughout the PATH-HOME trial.

The improvements in asthma control and the safety profile of Tezspire observed in the PATH-HOME trial were consistent with previous clinical trials.

Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.

Professor Ian Pavord, Professor of Respiratory Medicine at the University of Oxford and Honorary Consultant Physician at the Oxford University Hospitals, said: “Severe asthma continues to have a debilitating impact for people living with the disease.

I believe the approval of the Tezspire pre-filled pen will be welcome news for physicians and patients in Europe as it offers increased choice and greater flexibility when administering this important medicine.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Tezspire is the first and only biologic approved in Europe for patients with severe asthma with no phenotype or biomarker limitation.

With the approval of the Tezspire pre-filled pen, we can give patients in Europe greater flexibility and support physicians in treating a broad population of severe asthma patients.”

AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (FDA) on self-administration and the new pre-filled pen in the first half of 2023. 

Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries.”

https://www.astrazeneca.com/media-centre/press-releases/2023/tezspire-approved-for-self-administration-in-the-eu-in-a-new-pre-filled-pen.html

Pfizer Invites Public to Listen to Webcast of Pfizer Discussion at Healthcare Conference

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Pfizer Invites Public to Listen to Webcast of Pfizer Discussion at Healthcare Conference

January 03, 2023: “Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 3:00 p.m. Pacific Standard Time.To listen to the webcast, visit our web site at www.pfizer.com/investors.

Information on accessing and registering for the webcast will be available at www.pfizer.com/investors beginning today.

The transcript and webcast replay of the discussion will be made available on our web site at www.pfizer.com/investors within 24 hours after the end of the live discussion and will be accessible for at least 90 days.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives.

We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines.

Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.

Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world.

For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com.

In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice:The webcast may include forward-looking statements about, among other things, our anticipated operating and financial performance, reorganizations, business plans, strategy and prospects; expectations for our product pipeline, in-line products and product candidates, including anticipated regulatory submissions, data read-outs, study starts, approvals, launches, clinical trial results and other developing data, revenue contribution and projections, growth, performance, timing of exclusivity and potential benefits; strategic reviews; capital allocation objectives; dividends and share repurchases; plans for and prospects of our acquisitions, dispositions and other business development activities; and our ability to successfully capitalize on growth opportunities and prospects; manufacturing and product supply; our efforts to respond to COVID-19, including our COVID-19 products; our expectations regarding the impact of COVID-19 on our business, operations and financial results; and other statements about our business, operations and financial results, that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

A description of these risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

The forward-looking statements in the webcast speak only as of the original date of the webcast.

Pfizer assumes no obligation to update forward-looking statements contained in the webcast as the result of new information or future events or developments.“

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-invites-public-listen-webcast-pfizer-discussion-13

How to Find Paid Clinical Trials Near You

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How to Find Paid Clinical Trials Near You

“Are you looking for paid clinical trials near you? Here are a few tips for finding these opportunities:

  • Search online directories – Websites such as ClinicalTrials.gov and CenterWatch offer directories of clinical trials that are being conducted around the world. Use these resources to search for paid clinical trials in your area by location, condition, or treatment type.
    for example, you can follow the below steps to search paid trial in ClinicalTrials.gov.
    • go to ClinicalTrials.gov and in advance search option, you can enter the condition names ,locations and other criteria.
    • click on search option and you will get links of all relevant trials. Open the trial and search the keyword “contact” and you will get sponsor’s contact

  • Contact local hospitals and research centers – Many hospitals and research centers conduct clinical trials, and they may have information about current or upcoming trials that offer compensation to participants. Reach out to these institutions to learn more about paid clinical trial opportunities near you.
  • Ask your healthcare provider – Your healthcare provider may be aware of paid clinical trials that are being conducted in your area and may be able to refer you to these opportunities.
  • Check with patient advocacy groups – Patient advocacy groups, such as the American Cancer Society or the National Multiple Sclerosis Society, may have information about paid clinical trials that are relevant to your condition.

    You can learn more about clinical trial in below links:
  • https://lifepronow.com/2021/01/03/terminologies-of-clinical-trial/
  • https://lifepronow.com/2020/07/03/informed-consent-defination-and-informed-consent-form-example/

Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis

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Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis

December 21, 2022: “Pfizer announced that the U.S. FDA has accepted for review a New Drug Application (NDA) for etrasimod for individuals living with moderately-to-severely active ulcerative colitis (UC).

The FDA’s decision is expected in the second half of 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with the decision anticipated in the first half of 2024.

Etrasimod is an oral, once daily, selective sphingosine-1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptors 1, 4, and 5. In addition to UC, it is being investigated for a range of other immuno-inflammatory diseases.

UC is a chronic and often debilitating condition that affects an estimated 3.8 million people in North America and Europe.

Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain, and urgency.

UC can have a significant effect on work, family, and social activities. There is a need for additional advanced therapeutic options in UC that are oral, effective, and have a favorable risk-benefit profile.

“Ulcerative colitis can substantially impact the day-to-day lives of people living with this chronic and often debilitating disease, and many patients never achieve nor maintain remission on today’s therapies,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development.

“We believe that etrasimod, if approved, has the potential to be a best-in-class, first-line advanced therapy for people living with moderately-to-severely active ulcerative colitis, based on its clinical profile.”

These submissions were based on previously announced results from the ELEVATE UC Phase 3 registrational program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of etrasimod 2 mg once daily on clinical remission in UC patients who had previously failed or were intolerant to at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.

Both randomized, double-blind, placebo-controlled studies achieved all primary and key secondary endpoints, with a safety profile consistent with previous studies.

About ELEVATE UC 52 and ELEVATE UC 12
ELEVATE UC 52 and ELEVATE UC 12 are pivotal trials that are part of the ELEVATE UC Phase 3 registrational program.

ELEVATE UC 52 is a randomized, double-blind, placebo-controlled trial that utilized a treat-through design comprising of a 12-week induction period followed by a 40-week maintenance period.

Beginning at week 12, all patients could continue their randomized treatment; patients whose disease had not improved or had worsened compared to baseline could discontinue and, if eligible, enroll in an open-label extension study.

The primary objective of this trial was to assess the safety and efficacy of etrasimod 2 mg once daily on clinical remission after both 12 and 52 weeks. The primary endpoint is based on the 3-domain, modified Mayo score (MMS).

In ELEVATE UC 52, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P≤.001) and was 32.1% compared to 6.7% at week 52 (25.4% differential, P≤.001).

Statistically significant improvements were attained in all key secondary endpoints, including endoscopic improvement, symptomatic remission, and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52.

ELEVATE UC 12 is a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of etrasimod 2 mg once-daily in subjects with moderately-to-severely active UC.

The primary objective of this trial was to assess the safety and efficacy of etrasimod on clinical remission at 12 weeks assessed by the FDA-required, 3-domain, MMS.

In ELEVATE UC 12, clinical remission was achieved among 24.8% of patients receiving etrasimod compared to 15.2% of patients receiving placebo (9.7% differential, P=.0264).

All key secondary endpoints were met at week 12, including endoscopic improvement, symptomatic remission, and mucosal healing.

In ELEVATE UC 12, a similar proportion of patients experienced treatment-emergent adverse events (AEs) between etrasimod 2 mg and placebo treatment groups, while in ELEVATE UC 52, it was higher in the etrasimod 2 mg group compared to placebo. The proportion of patients experiencing serious AEs was similar between treatment groups in both trials.

The most common treatment-emergent AEs in 3% or more of etrasimod-treated patients and greater than placebo up to week 52 in either trial were headache, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea.

There were no reports of bradycardia or atrioventricular block as serious AEs. Data support initiation of etrasimod treatment does not require complex up-titration regimen.

Nearly two-thirds of patients in ELEVATE UC 52 and ELEVATE UC 12, respectively, were naïve to biologic or JAK inhibitor therapy.”

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-fda-and-ema-acceptance-etrasimod

FDA Approves New HIV Drug for Adults with Limited Treatment Options

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FDA Approves New HIV Drug for Adults with Limited Treatment Options

December 22, 2022: “The U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations.

After the starting dose is completed, Sunlenca is administered as subcutaneous (under the skin) injections once every six months, allowing convenient dosing for patients.

“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.

“The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”

Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1.

Sunlenca works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle.

Sunlenca’s starting dose is given as oral tablets and subcutaneous injections, followed by maintenance injections every six months; Sunlenca is given in combination with other antiretroviral(s). 

The safety and efficacy of Sunlenca were established through a multicenter clinical trial with 72 patients whose HIV infections were resistant to multiple classes of HIV medications.

These patients had to have high levels of virus in their blood despite being on antiretroviral drugs.

Patients were enrolled into one of two study groups. One group was randomized to receive either Sunlenca or placebo in a double-blind fashion, and the other group received open-label Sunlenca.

The primary measure of efficacy was the proportion of patients in the randomized study group who achieved a certain level of reduction in virus during the initial 14 days compared to baseline.

In this group, 87.5% of patients who received Sunlenca achieved such a decrease in virus compared to 16.7% of patients who received a placebo.

After 26 weeks of Sunlenca plus other antiretrovial drugs, 81% of participants in the first group achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable.

After 52 weeks, 83% of participants continued to have HIV RNA suppression.

The most common adverse reactions with Sunlenca were injection site reactions and nausea. Most injection site reactions were described as swelling, pain or redness. Sunlenca comes with certain warnings and precautions.

Injection site reactions described as nodules or indurations may be persistent in some patients.

Additional warnings and precautions include the risk of developing immune reconstitution syndrome, which is when the immune system overreacts after starting HIV treatment.

Also, small (residual) amounts of Sunlenca can remain in the body for up to a year or longer; low levels of drug caused by missing doses of Sunlenca or failing to maintain a fully suppressive HIV treatment regimen after stopping Sunlenca could lead to an increased risk of developing viral resistance.

Residual amounts of Sunlenca could also lead to potential drug interactions.

Patients should not receive Sunlenca if they also take certain drugs that cause reduced levels of Sunlenca. This may result in losing virologic response and developing viral resistance. 

The FDA granted Sunlenca Priority Review, Fast Track and Breakthrough Therapy designations for this indication. 

The FDA granted the approval of Sunlenca to Gilead Sciences.”

https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-drug-adults-limited-treatment-options

Lynparza with abiraterone approved in EU for metastatic castration-resistant prostate cancer

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Lynparza with abiraterone approved in EU for metastatic castration-resistant prostate cancer

December 21, 2022: “AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the European Union for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy is not clinically indicated.

This approval by the European Commission was based on results from the PROpel Phase III trial and follows the positive recommendation in the EU by the Committee for Medicinal Products for Human Use in November 2022.

In the trial, Lynparza in combination with abiraterone and prednisone or prednisolone, reduced the risk of disease progression or death by 34% versus abiraterone and prednisone or prednisolone (based on a hazard ratio [HR] of 0.66; 95% confidence interval [CI] 0.54-0.81; p<0.0001).

Median radiographic progression-free survival (rPFS) was 24.8 months for Lynparza plus abiraterone versus 16.6 months for abiraterone alone.

Furthermore, a planned rPFS analysis by blinded independent central review (BICR) showed Lynparza plus abiraterone had a median rPFS of 27.6 months compared to 16.4 months with abiraterone alone, extending median rPFS by almost one year.

Updated results from a second planned analysis presented at ESMO 2022 showed a favourable trend towards improved overall survival with Lynparza plus abiraterone versus abiraterone alone (based on HR of 0.83; 95% CI 0.66-1.03; p=0.11), however, the difference did not reach statistical significance at the time of this data cut-off (analysis at 40% data maturity).

Prostate cancer is the most common cancer in men in Europe, with an estimated 473,000 patients diagnosed and 108,000 deaths in 2020.

Overall survival for patients with mCRPC is approximately three years in clinical trial settings, and even shorter in the real-world.

Approximately half of patients with mCRPC may receive only one line of active treatment, with diminishing benefit of subsequent therapies.

Noel Clarke, Urological Surgeon and Professor of Urological Oncology at Manchester’s Christie/Salford Royal Hospitals and Manchester University, a senior investigator of the PROpel trial, said: “The results of the PROpel Phase III trial of olaparib in combination with abiraterone as a first-line treatment show that this therapeutic combination can provide significant clinical benefit to patients with metastatic castration-resistant prostate cancer.

Patients with this condition in the EU will now, for the first time, have the opportunity to benefit from this new treatment combination.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Many patients with metastatic castration-resistant prostate cancer are only able to receive one line of active therapy, as the disease can progress quickly. 

Lynparza in combination with abiraterone has been shown to reduce the risk of disease progression by 34% versus the standard of care treatment in the PROpel trial.

Moreover, the combination of Lynparza with abiraterone as a first-line treatment expands the use of Lynparza to a broader group of metastatic castration-resistant prostate cancer patients than those treated with Lynparza alone in the second-line setting in the PROfound trial.

Today’s approval marks a significant advance toward addressing the unmet need of patients with metastatic castration-resistant prostate cancer in the EU.”

Dr. Eliav Barr, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer, MSD Research Laboratories, said: “MSD is committed to developing new treatment options for patients with metastatic castration-resistant prostate cancer, a complex disease that urgently needs more therapies.

This approval by the European Commission marks another step towards delivering on that commitment and we look forward to extending the benefits of Lynparza to more patients with metastatic castration-resistant prostate cancer in the EU.”

The safety and tolerability of Lynparza in combination with abiraterone in PROpel was in line with that observed in prior clinical trials and the known profiles of the individual medicines.

There was no increase in the rate of discontinuation of abiraterone in patients treated with Lynparza in combination with abiraterone and no detrimental effect on health-related quality of life versus those treated with abiraterone alone (Functional Assessment of Cancer Therapy-Prostate questionnaire).

In August, supplemental New Drug Application (sNDA) for Lynparza in combination with abiraterone and prednisone or prednisolone was accepted and granted Priority Review in the US for the treatment of adult patients with mCRPC.

The Prescription Drug User Fee Act (PDUFA) date is anticipated during the first quarter of 2023.

Lynparza is approved in the US based on results from the PROfound Phase III trial as monotherapy for patients with homologous recombination repair (HRR) gene-mutated mCRPC (BRCA and other HRR gene mutations) who have progressed following prior treatment with enzalutamide or abiraterone; and in the EU, Japan, and China for patients with BRCA-mutated mCRPC who have progressed following prior therapy that included a new hormonal agent.

Financial considerations
Following this approval for Lynparza in the EU, AstraZeneca will receive a regulatory milestone payment from MSD of $105m, anticipated to be booked as Collaboration Revenue by the Company during the fourth quarter of 2022.”

https://www.astrazeneca.com/media-centre/press-releases/2022/lynparza-approved-in-eu-for-prostate-cancer.html

Imfinzi plus chemotherapy approved in EU for patients with advanced biliary tract cancer

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Imfinzi plus chemotherapy approved in EU for patients with advanced biliary tract cancer

December 21, 2022: “AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).

The approval by the European Commission was based on the primary results from the TOPAZ-1 Phase III trial published in the New England Journal of Medicine Evidence, and on the updated results presented at the European Society for Medical Oncology Congress 2022.

The approval follows the recommendation by The Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2022.

At the interim analysis, Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone (based on a hazard ratio [HR] of 0.80; 95% confidence interval [CI] 0.66-0.97; p=0.021).

Updated results from TOPAZ-1 after an additional 6.5 months of follow-up showed a 24% reduction in the risk of death versus chemotherapy alone (HR 0.76; 95% CI, 0.64-0.91), with more than two times as many patients treated with Imfinzi plus chemotherapy estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%).

Updated median overall survival (OS) was 12.9 months versus 11.3 with chemotherapy.

BTC is a group of rare and aggressive cancers that occur in the bile ducts (cholangiocarcinoma) and gallbladder.

There are approximately 211,000 new patients diagnosed with gallbladder and biliary tract cancer each year, and about 40,000 of these occur across Europe.

These patients have a poor prognosis, with approximately 5% to 15% of patients with BTC surviving five years.

Juan W. Valle, MD, Professor of Medical Oncology at the University of Manchester and The Christie NHS Foundation Trust, UK, and a lead investigator in the TOPAZ-1 Phase III trial, said: “Today’s approval marks an important shift in the treatment of this aggressive and often overlooked disease and a significant improvement compared to standard of care for these patients.

After waiting over a decade for new therapeutic options, biliary tract cancer patients in the EU will now have the opportunity to benefit from an immunotherapy-based treatment for the first time.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “With this approval, Imfinzi plus chemotherapy becomes the only immunotherapy-based treatment option available to patients in the EU with advanced biliary tract cancer.

This approval underscores our commitment to transform survival outcomes while addressing the high unmet need for new and improved treatments for patients with hepatobiliary cancers.”

Imfinzi plus chemotherapy was generally well tolerated, with no new safety signals observed, and did not increase the discontinuation rate due to adverse events (AEs) compared to chemotherapy alone.

Grade 3 or 4 treatment-related AEs were experienced by 60.9% of patients treated with Imfinzi plus chemotherapy, and by 63.5% of patients treated with chemotherapy alone.

Imfinzi plus chemotherapy is approved in the US and other countries for the treatment of adults with locally advanced or metastatic BTC.

Regulatory applications are also currently under review in Japan and several other countries based on the TOPAZ-1 results.”

https://www.astrazeneca.com/media-centre/press-releases/2022/imfinzi-approved-in-eu-for-biliary-tract-cancer.html

FDA Provides Update on External Evaluation to Strengthen Agency’s Tobacco Program

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FDA Provides Update on External Evaluation to Strengthen Agency’s Tobacco Program

December 19, 2022: “Earlier this year, I commissioned an external evaluation External Link Disclaimer of the U.S. Food and Drug Administration’s Tobacco Program, to be conducted by an external expert panel facilitated by the Reagan-Udall Foundation, led by former FDA Chief of Staff Lauren Silvis.

The panel was asked to assess the Tobacco Program’s regulatory processes and agency operations relating to regulations and guidance, application review, compliance and enforcement and communication with the public and other stakeholders.

Today, the panel released its findings and recommendations to the agency. I want to thank the panel and the Reagan-Udall Foundation for their work and for all those, including FDA staff and external stakeholders, who provided important feedback for the panel to consider. 

Over the next several weeks, Center for Tobacco Products leadership will closely review the report’s findings and recommendations, in consultation with the Commissioner’s Office, to determine next steps and will provide an update by early February.

Importantly, since joining the FDA as the director for the Center for Tobacco Products in July, Brian King, Ph.D., M.P.H., has continued to build on the work of his predecessors while also implementing changes to best position the center for success moving forward.

This work is particularly critical as we focus on preventing initiation, while also helping people quit, especially the deadliest form of tobacco use, combustible tobacco products. Despite meaningful declines in cigarette use over the past several decades, nearly 500,000 Americans still die every year from cigarette smoking.

Additionally, with more than 3 million youth reporting current use of a tobacco product in 2022, and e-cigarettes being the most used product, we risk another generation becoming addicted to these products. 

While we consider potential improvements to our operations and processes for tobacco product regulation, we are committed to communicating any changes with clarity and transparency for our many stakeholders.

For the FDA to build on this work in the ever-evolving tobacco marketplace, it’s also critical to ensure CTP has what it needs to adequately and efficiently address the recommendations in the report. 

We’ve made important progress and reached science-based regulatory decisions across a broad array of products in the 13 years since Congress tasked the FDA with regulating tobacco products.

And as I’ve noted previously, even greater challenges and opportunities lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant impact on public health. 

The hardworking and talented individuals in CTP, and across the FDA, deserve the best support possible so they can fulfill their strong commitment to public health – and the American public that we serve.

It is my belief that this effort will continue strengthening the FDA and better position the agency to deal with the many immediate public health issues related to tobacco products we are facing, while preparing for challenges and opportunities in the future.”

https://www.fda.gov/news-events/press-announcements/fda-provides-update-external-evaluation-strengthen-agencys-tobacco-program

Federal Court Enters Consent Decree Against Oklahoma Drug Compounder

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Federal Court Enters Consent Decree Against Oklahoma Drug Compounder

December 19, 2022: “The U.S. District Court for the Western District of Oklahoma entered a consent decree against Qualgen LLC, an outsourcing facility with a history of violations.

The consent decree prohibits the company from directly or indirectly distributing adulterated drugs in interstate commerce.

The consent decree entered against Qualgen, its majority owner, Shaun Riney, and its Director of Quality, Jasen Lavoie, follows a complaint filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration.

The complaint asserts that Qualgen introduced into interstate commerce adulterated drugs that were manufactured, processed, packed or held under conditions that violate current good manufacturing practice (CGMP) requirements. 

“While drugs compounded by outsourcing facilities are not subject to pre-market review and approval by the FDA for safety and effectiveness, they must comply with rigorous manufacturing quality assurance requirements,” said Jill P. Furman, J.D., acting director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.

“The FDA’s commitment to ensuring compliance with current good manufacturing practice requirements is a critical protection for patients. We will remain vigilant and hold all manufacturers accountable to best protect the public health.” 

Under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a compounder can register as an outsourcing facility, which is defined as a facility at one geographic location or address that is engaged in the compounding of sterile drugs, has elected to register as an outsourcing facility and complies with all the requirements of section 503B of the FD&C Act.

Qualgen is registered with the FDA as an outsourcing facility. 

Drugs compounded by an outsourcing facility can qualify for exemptions from FDA approval requirements and the requirement to label products with adequate directions for use, but not from CGMP requirements. 

The agency inspected and cited Qualgen for violations of CGMP requirements during several inspections since 2015, issuing a safety alert in 2015 and a warning letterExternal Link Disclaimer in 2016.

The FDA’s most recent inspection of Qualgen’s Oklahoma facilities ended in September 2022. Qualgen manufactures and ships compounded drugs from its Oklahoma facilities.

Compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product.

Compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety or efficacy.

The case was filed by the U.S. Department of Justice’s Consumer Protection Branch, on behalf of the FDA.”

https://www.fda.gov/news-events/press-announcements/federal-court-enters-consent-decree-against-oklahoma-drug-compounder

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