WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Though Moderna’s vaccine deal with the U.S. was announced with a $1.5 billion tag, it could be worth a lot more. With options fully exercised, follow-up doses and an early approval, the mRNA developer may take home $8.125 billion, all told. Meanwhile AstraZeneca is adding more to its to-do list, pledging 400 million doses to the EU after inking deals with several countries. Elsewhere, the FDA greenlit the saliva test used in the NBA Bubble, and Fitbit shows its trackers can pick up early signs of COVID-19. Those stories and more follow below. | |
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Featured Story | By Nick Paul Taylor The FDA has rejected Gilead’s filing for approval of filgotinib in rheumatoid arthritis. With the FDA asking to see data from an ongoing clinical trial, Gilead is unlikely to be able to refile until toward the middle of next year, pushing it still further behind its rivals for the JAK inhibitor market. read more |
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Top Stories Of The Week By Eric Sagonowsky Under Moderna's coronavirus vaccine deal with the U.S., announced last week with a $1.525 billion price tag, the mRNA biotech stands to gain a whopping $8.125 billion if all options are exercised. That's according to a securities filing that offers more details of the partnership, including a $300 million for early approval and the price for follow-up doses. read more By Conor Hale The company said its devices have been able to detect nearly half of COVID-19 cases at least one day before the participant reported any fever, cough or pain. read more By Eric Sagonowsky As Johnson & Johnson, Sanofi and GlaxoSmithKline move ahead in advanced COVID-19 vaccine supply negotiations with the EU, AstraZeneca has signed into the union’s first finalized agreement. read more By Ben Adams As the months tick down before the November election, President Donald Trump is seemingly under increasing pressure to find vaccines and treatments for COVID-19. read more By Eric Sagonowsky Now that the intense hydroxychloroquine debate has lost steam, President Trump is reportedly eyeing another “miracle” therapy without evidence to back it up. The president and allies see oleandrin, an extract of the oleander plant, as a useful dietary supplement—or even an FDA-approved therapy—to treat or prevent COVID-19, Axios reports. read more By Ben Adams Making good on its 2017 promise to back post-Brexit Britain, U.S. Big Pharma Merck is set to spend £1 billion ($1.31 billion) on a new unifying early research hub in England’s capital city. read more By Eric Sagonowsky Treatment for neuromyelitis optica spectrum disorder has transformed over the last year with FDA approvals for Alexion‘s Soliris and Viela Bio’s Uplizna, but now pharma giant Roche is entering the fray. Enspryng, formerly known as satralizumab, has scored an FDA approval. read more By Conor Hale The rapid, saliva-based coronavirus test used to screen NBA players within “the bubble” as they work through their current basketball season has now been authorized by the FDA for use across the country. read more By Angus Liu UnitedHealthcare has a history of limiting HIV drug costs, including offering cash incentives to patients who opt for low-priced regimens. Now, in a potentially major blow to HIV giant Gilead Sciences, the insurer has set its eyes on one of the California drugmaker's new therapies. read more By Arlene Weintraub UCSF researchers engineered a three-part antibody chain to block COVID-19 that's inspired by the tiny nanobodies that llamas and other camelids make naturally to fight off pathogens. They believe the treatment could be delivered as an aerosol and used as a self-administered form of protection against the virus. read more By Kyle Blankenship With the last three months of the year fast approaching, players in the global hunt for a COVID-19 vaccine are gearing up for what will likely be a busy final quarter. Now, one of the world's largest vaccine makers is looking to raise a massive sum to boost its production of up to five candidates. read more Enrollment Showcase | Presented by: Biotility Taught by experienced professionals, Biotility’s online short courses provide the knowledge and practical skills valued by the bioscience industry. Enhance your career through coursework in one of our certificate pathways, including Document Management, Operations Management, and Quality Management. Learn more. |
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Resources 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: LexisNexis Risk Solutions Pharma marketing ROI soars when powered by claims data insights. 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. | 
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