WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Hope springs, for the second week in a row: Moderna’s COVID-19 vaccine hit its phase 3 primary endpoint, posting 94.5% efficacy with no severe cases of the disease. That news joins Pfizer and BioNTech’s similarly mRNA-based shot, which has delivered similar levels of effectiveness—and now both teams have their eyes on obtaining the FDA’s blessing, before racing to produce tens of millions of doses. Still, the agency’s review may take weeks, as it pursues a thorough and transparent process that aims to not only validate the injections, but to also ensure the public has trust in any vaccine, with the stakes being so high. | |
|
Featured Story | By Nick Paul Taylor Moderna’s phase 3 COVID-19 vaccine has hit its primary endpoint with efficacy of 94.5%. Ninety cases of COVID-19, including all 11 severe cases seen so far, happened in the placebo cohort, versus five cases among people who received mRNA-1273. read more |
| |
|---|
|
|  | Webinar: Examining Rare Disease Biology with NLP Text Mining Wednesday, December 2 | 11am ET / 8am PT Dr. David Merberg, from Takeda, will discuss the value of text analytics for the identification of genetic mutations, genotype-phenotype association and disease severity, in order to develop a better understanding around the biology of rare diseases. Register now! |
Top Stories Of The Week By Angus Liu Scientists are continuing to try to repurpose existing medicines as a fast approach to containing COVID-19. After analyzing a large patient registry, researchers at the Cleveland Clinic suggested that a popular over-the-counter sleep aid melatonin may be a possible option for the disease. read more By Eric Sagonowsky Gilead’s remdesivir, now known as Veklury, is perhaps the most successful COVID-19 drug so far. It scored a full FDA nod in October after months of emergency use and brought in $873 million last quarter. But an influential European medical association now says it shouldn't be used in intensive care patients. read more By Eric Sagonowsky A week after Pfizer posted impressive early coronavirus vaccine efficacy numbers, Moderna took the spotlight early Monday with impressive findings of its own. But separate from its big announcement, the mRNA biotech said its vaccine can be kept at refrigerated temperatures for 30 days, reducing hurdles for a potential large-scale rollout. read more By Nick Paul Taylor Pfizer is preparing to file its COVID-19 vaccine for emergency use authorization (EUA) after passing a key safety milestone. CEO Albert Bourla, Ph.D., said Pfizer now has the median two-month follow-up data needed to secure EUA from the FDA, putting it a step closer to bringing its vaccine to market in the U.S. read more By Eric Sagonowsky As leading COVID-19 vaccines post positive phase 3 data and near FDA submissions, the agency official in charge of reviewing vaccines is emphasizing transparency and patience during the high-stakes process. Americans should expect reviews to take weeks rather than days, according to Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research. read more By Conor Hale The FDA has authorized its first all-in-one COVID-19 diagnostic that allows people to test themselves within their own home, from a swab to a result in about 30 minutes. read more By Ben Adams Johnson & Johnson is confident that it has a one-dose knockout vaccine that can protect against COVID-19, but it’s now starting a late-stage two-dose test just in case. read more By Kyle Blankenship With a range of COVID-19 vaccine candidates nearing the finish line, more eyes are turning to the strength of drugmakers' supply chains to meet global demand. One of the drugmakers leading the pack—Johnson & Johnson—can tout a supply chain that's the best in its field, a new report finds. read more By Angus Liu Roche’s Tecentriq has some company in triple-negative breast cancer. Merck’s Keytruda, used in tandem with chemo, has won FDA accelerated approval to treat triple-negative breast cancer patients whose tumors express high levels of PD-L1 at a combined positive score of at least 10. read more By Nick Paul Taylor D3 Bio has emerged with $200 million from a syndicate of heavy hitters and an ex-AstraZeneca leader in the CEO role. George Chen, M.D., set up D3 Bio after seven years at AstraZeneca and persuaded investors including Sequoia Capital China and Temasek to bankroll his plans. read more Resources Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored By: WCG Need additional site resources for your current or upcoming clinical trial? Sponsored By: BioAnalytix Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. Sponsored By: Medidata Responding to site challenges. Approaching virtualization. Leveraging real-time data. Medidata shares 8 parameters to implement your virtualization strategy during COVID-19 and beyond. Download Now. Sponsored By: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. Sponsored By: Thermo Fisher Scientific One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline. Sponsored By: Clinical Ink This white paper covers a Phase III case study; BYOD advantages and misconceptions; and regulatory, copyright, and equivalency considerations. Sponsored By: Thermo Fisher Scientific Anticipate early development challenges to avoid rework and costs. Sponsored By: Cytiva Accelerating the production of viral-vector based therapy requires both understanding of strategies to address viral vector manufacturing and how to select the most cost-effective solution for your therapeutic. Read more in this article. Sponsored by: LexisNexis Risk Solutions Get insights into healthcare decision-makers networks. Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Learn about proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. 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: 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: 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. | 
