WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST AstraZeneca’s temporary pause of its COVID-19 vaccine trial has caused concerns at “the highest levels of NIH,” as the FDA assesses the case and U.K. regulators give the green light to resume. Observers have called for AstraZeneca to be more forthcoming on the diagnosis that led to the clinical hold, as well as with the data that cleared it to continue. Meanwhile, Eli Lilly found that its Olumiant helped improve patient recovery when combined with Gilead’s remdesivir—and it’s pursuing an FDA authorization to provide one of the few treatments we’ve seen for COVID-19 so far. | |
|
Featured Story | By Nick Paul Taylor Leaders at the National Institutes of Health are “very concerned” about the adverse event that led AstraZeneca to pause its COVID-19 vaccine clinical trial, according to the intramural clinical director at one of its divisions. read more |
| |
|---|
|
Top Stories Of The Week Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. read more By Eric Sagonowsky The pharma industry’s massive pandemic response may have yielded another winner, as Eli Lilly’s Olumiant—combined with Gilead Sciences' remdesivir—improved recovery time in patients hospitalized with COVID-19. And with those data, Lilly's plotting its course for an FDA emergency authorization. read more By Nick Paul Taylor Merck has struck a deal to develop Seattle Genetics’ antibody-drug conjugate ladiratuzumab vedotin. The agreement will see Merck pay $600 million and make a $1 billion investment in Seattle Genetics in return for the chance to embark on a joint development program. read more By Kyle Blankenship As new COVID-19 infections and deaths continue to march downward in the U.S., companies are having to make a difficult choice: Stay at home or back to business as usual? For drugmaker AbbVie, this week marks a return to normal for part of its workforce—but some employees have their reservations. read more By Angus Liu A research team led by the University of Pittsburgh School of Medicine has identified an antibody component that’s 10 times smaller than a full-sized antibody. They constructed a drug with it and found it to be effective in preventing and treating SARS-CoV-2 in rodent models. Its small size might make it amenable to inhaled formulations. read more By Eric Sagonowsky As Pfizer moves ahead in COVID-19 vaccine research at record speeds, executives on Tuesday detailed a "mostly mild to moderate” safety profile, with rare instances of severe or grade 4 side effects. read more By Amirah Al Idrus Frequency Therapeutics’ hearing loss treatment showed early signs of efficacy last year, with some patients showing improvements after a few months. Now, as the biotech plugs away at a phase 2a study, it’s reporting new data showing the drug’s effects lasting as far out as 21 months. read more By Angus Liu Despite Tagrisso rapidly establishing itself as the new standard of care for EGFR-mutated non-small cell lung cancer, its maker AstraZeneca has had a hard time convincing England’s drug cost watchdog of its worth. As of Friday, though, it's made some progress in that department, convincing the The National Institute for Health and Care Excellence (NICE) to reverse a negative decision. read more By Conor Hale The FDA outlined the limits of 58 different COVID-19 tests, illustrating their ability to detect smaller amounts of the novel coronavirus. read more By Kyle Blankenship Despite a lackluster history of taking vaccines to market, Maryland's Novavax is streaking through clinical trials for its promising COVID-19 shot candidate. Going commercial is a whole other beast, however, and Novavax is now expanding one of its key manufacturing deals to aid the cause. read more Resources Sponsored by: Evidation Health Achieving patient centricity depends on evolving how evidence is generated. Sponsored by: 4G Clinical This white paper addresses the complexity of basket and umbrella designs, and how modern technology is critical to run flexible, agile and quality-driven trials. Sponsored by: EVERSANA How independent drug launch and commercialization can lead to higher market capitalization. Sponsored by: AMRI Download our white paper to learn more about the growth trends, complex anatomy and intricacies of developing these armed antibodies, as well as AMRI’s approach to their discovery and development. Sponsored by: LexisNexis Risk Solutions Avoid severe compliance penalties by staying on top of evolving laws. Sponsored by: Quotient Sciences This white paper will discuss four principal CMC challenges for the developers of orphan drugs, and the potential solutions which are emerging. Download now >> Sponsored by: Clarify Health In 2020, QED Therapeutics launched first-in-class infigratinib for cholangiocarcinoma (CCA). Learn how the launch team precisely identified and characterized eligible patients by taking an evidence-based approach to its commercial strategy. Sponsored by: Benchling Life science R&D generates a LOT of data. Learn how to make sense of it and harness its potential with this step-by-step guide. Sponsored by: Thermo Fisher Scientific Don’t oversimplify your solubility challenges. Sponsored by: Clinical Ink Download this free whitepaper to learn how to execute fast, high-quality clinical trials through eSource for studies that boost efficiency for both sponsors and sites. Sponsored by: PRA Health Sciences Drug developers and stakeholders must find ways to collaborate, rather than compete, as the RACE Act prompts the need for more pediatric research. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Thermo Fisher Scientific Download the whitepaper to learn more. 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. 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: 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: 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. | 
.gif)
