WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Critics slammed the FDA for authorizing convalescent plasma prematurely and overstating its benefits, with the agency’s reputation on the line as the election nears and drugmakers race to complete their COVID-19 vaccines. Reports surfaced this week that the White House may fast-track AstraZeneca’s before November, and before a late-phase trial. Meanwhile, the Trump administration revoked the FDA’s authority over lab-developed tests, days after the president accused agency staff of slowing approvals to hurt his re-election chances. Commissioner Hahn later walked back his claims of plasma’s successes, but Congress still wants assurances that the agency is protected from political pressure. Those stories and more follow below. | |
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Featured Story | By Amirah Al Idrus As seen in 45 younger adults, the middle dose of Moderna’s COVID-19 vaccine triggered the production of neutralizing antibodies against SARS-CoV-2, the virus that causes COVID-19, in 10 patients aged 56 to 70 and 10 patients over 71. The patients’ antibody levels were two to three times higher than those seen in patients who recovered from the disease. read more |
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Top Stories Of The Week By Eric Sagonowsky It’s been some months since Biogen’s February management conference has been in the news, but as the pandemic drags on, researchers are now linking the early “superspreading event” with tens of thousands of cases in the U.S.—if not more. read more By Nick Paul Taylor President Donald Trump is considering fast-tracking the authorization of AstraZeneca’s COVID-19 vaccine to ensure a jab is available in time for the November election, according to the Financial Times. The mooted plan is to allow AstraZeneca to gain emergency use authorization on the basis of a 10,000-subject U.K. clinical trial. read more By Beth Snyder Bulik The flip-flop emergency approval of convalescent plasma by the FDA sparked a social media wildfire of criticism—and cast a shadow on the agency’s reputation. Many criticized the FDA and Commissioner Stephen Hahn over the plasma EUA for COVID-19 patients and the appearance of President Trump's involvement. read more By Eric Sagonowsky As criticism of the FDA's convalescent plasma authorization mounted Monday, Commissioner Stephen Hahn, M.D., sought to clear the air. But his defense—and his attempt to correct a misplaced statistic—didn't sit well with some experts. read more By Conor Hale The Trump administration has revoked the FDA’s authority over lab-developed tests, including requirements that diagnostics made for COVID-19 go through the agency’s emergency review and authorization process. read more By Eric Sagonowsky With several COVID-19 vaccines already in phase 3 trials and investigators aiming to enroll tens of thousands of participants, Johnson & Johnson is prepping the largest study so far. The pharma giant aims to enroll a whopping 60,000 participants—twice as many as rivals Moderna and Pfizer—in a phase 3 trial set to begin next month. read more By Kyle Blankenship After finding high levels of a probable carcinogen in samples of the common diabetes med metformin, the FDA has scrambled to get affected lots out of consumers' hands. Now, the agency has spotted a sixth drugmaker with a contaminated version of the drug. read more By Nick Paul Taylor Pfizer and BioNTech have published clinical data on the COVID-19 vaccine they advanced into phase 3. The early clinical data link the phase 3 candidate to a far lower rate of adverse events than another prospect, explaining Pfizer and BioNTech’s decision to move it into late-stage testing. read more By Arlene Weintraub Scientists at Rutgers University have developed a technique that uses light to detect changes in RNA at the single-cell level. The method could be used to track the evolution of SARS-CoV-2 and perhaps help solve mysteries such as why some people are super-spreaders of the virus and others are not. read more | | Webinar: Wearable Technology for High-Frequency Cognitive and Mood Assessments in Depression September 17, 2020 | 11am ET / 8am PT The widespread adoption of smartphones and wearables makes monitoring symptoms in real time a credible option using brief measures designed for these devices – but is this acceptable and feasible for patients? Register now to learn the research findings of Takeda Pharmaceuticals, Cambridge Cognition, and CTRL Group, and share lessons learned adopting new technologies in clinical trials. |
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Resources Sponsored by: LexisNexis Risk Solutions Traditionally, pharma companies use a combination of prescription data & internal sales reports to look for potential buyers. Such practice provides only a LIMITED VIEW without competitor information. Sponsored by: Optum Download the whitepaper by Optum to see how novel data platforms can uncover hidden insights on medication adherence helping life sciences companies maximize product utilization. Sponsored by: Oracle Health Sciences Patient-facing digital technologies are playing an important role in clinical trials for new drugs and medical devices, to the point where conducting virtual trials is becoming mainstream. But terms like remote trials, direct-to-patient trials, hybrid trials, decentralized trials, and more all add to the confusion of what makes a trial "virtual." Sponsored by: Oracle Health Sciences The research conducted here is to help understand and solve the top challenges in clinical operations, to remove barriers that are slowing down our ability to bring new drugs to market as quickly as possible to patients waiting in need. Sponsored by: Thermo Fisher Scientific How to select the right dosage form for your Phase I clinical supply. Sponsored by: Thermo Fisher Scientific Quality by Design (QbD) reduces risk within drug development, while bringing therapies to market quicker. Sponsored by: Evotec Two informative webcasts will present practical and methodological approaches to preclinical drug abuse liability assessment Sponsored by: Catalent Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. Sponsored by: Acorn AI by Medidata, a Dassault Systèmes company Case Study: Oncology-focused pharmaceutical company strengthens product launch by identifying hundreds of high-value physicians with Acorn AI. Sponsored by: Cardinal Health 3PL Services Identifying opportunities to simplify channel strategies and business processes for biopharma companies, their customers and patients. Sponsored by: Paysign Download the whitepaper for a solution designed to connect manufacturers, pharmacists, and patients. In this special guide, you will learn not just about the law but about the portal platform designed to change the entire process for all. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Catalent Learn about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. | 