| | Webinar: 2021 Apollo Healthcare Predictions Thursday, February 4, 2021 | 1pm ET / 10am PT With so much disruption from COVID-19, this year’s global insights will provide a unique window into the minds of those professionals perhaps most tested by 2020 and their hopes and perspectives for 2021. Register Now! |
WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Pfizer and BioNTech plan to boost their vaccine production to 2 billion doses this year—but to do so will require disrupting production to upgrade factory equipment. That means supplies may run short in Europe, Canada and elsewhere before getting back on track with “significantly more doses” later this year. Meanwhile, a former Merck scientist is facing up to 10 years after being charged with stealing Keytruda trade secrets. Also, our reader poll got a clear answer: Most would be surprised if J.P. Morgan’s healthcare conference returned to San Francisco after going virtual this year. But if JPM does move, where will it go? Those responses, plus our top stories of the week, follow below. | |
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Featured Story | By Eric Sagonowsky Last week, Pfizer and BioNTech said they were boosting vaccine production to 2 billion doses this year. There's a catch, though: Scaling up a factory in Belgium to help meet that goal means supplies will run short temporarily. read more |
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Top Stories Of The Week By Nick Paul Taylor A former Merck immuno-oncology director faces up to 10 years in prison for allegedly stealing trade secrets about Keytruda and other drugs. The researcher is charged with stealing and transmitting trade secrets around the time he left Merck to take up a position at AstraZeneca in 2019. read more By Ben Adams A drug that Pfizer passed over but saw a revitalized cancer R&D-focused GlaxoSmithKline jump on for $4.2 billion has come up as a dud in a key trial pitting it against U.S. Merck’s blockbuster Keytruda. read more By Angus Liu As supplies of Pfizer-BioNTech and Moderna’s authorized COVID-19 vaccines make their way around the country, many states are expanding beyond the 75-plus age group to reach people 10 years younger. That broader rollout has older people asking to drop out of Novavax's phase 3 vaccine trial. read more By Angus Liu The top concern for Bayer’s pharma business is the looming patent cliff for its two best-sellers—blood thinner Xalreto and eye drug Eylea. The meds will leave a revenue gap that even a couple blockbuster launches won’t be able to fill in the next few years, Bayer pharma president Stefan Oelrich said. read more By Ben Adams The November election now seems such a long time ago: It has, in fact, been less than three months, but that time has been filled with political and scientific catastrophes that will shape President Joe Biden’s term in office. read more By Carly Helfand We hear you guys loud and clear: You’re pretty sure J.P. Morgan’s days in San Francisco are done, and you basically couldn’t be happier about it. At least, that’s the message we got from voters who weighed in on last week’s poll about what the meeting will look like after it returns from virtual-only. read more By Conor Hale Thermo Fisher's CEO said 2021 will see the company quickly accelerate its long-term plans, including a full pipeline of M&A deals. He wasn’t kidding. read more By Nick Paul Taylor A clinical trial has found a COVID-19 vaccine in development at a Sinopharm subsidiary to be safe in children aged three to 17 years, according to Chinese state media. read more By Arlene Weintraub GlaxoSmithKline CEO Emma Walmsley is overseeing a makeover that includes major capital investments meant to boost the company's pharmaceutical pipeline. But with recent disappointments—including Wednesday's failure for a cancer drug licensed in a $4.6 billion deal—analysts are questioning its outlook. read more By Angus Liu Daiichi Sankyo and partner AstraZeneca have taken their HER2-targeted cancer drug Enhertu another step toward blockbuster land. The FDA cleared the med for use in HER2-positive stomach cancer patients who previously received Roche’s standard-of-care Herceptin. read more By Arlene Weintraub Studies have shown that disruptions in circadian rhythms caused by chronic sleep deprivation and other lifestyle-related issues are linked to an increased incidence of some cancers, including prostate cancer. A new study found that a "clock" gene called CRY1 is elevated in late-stage prostate cancer—a discovery that could inspire new treatments. read more | | Whitepaper: The Art of Recognizing Clinical Supply Risk Factors In an industry survey of 150+ individuals with responsibility for clinical supplies, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, Catalent's Clinical Supply Management team developed a factbased methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Download Now. |
Resources 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: Blue Matter Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.” Sponsored by: GenScript A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields. Sponsored by: Catalent Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity. Sponsored by: AllianceRx Walgreens Prime Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. 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: 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: 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 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. | 