WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST As we look to a new year and new vaccines to get us past the COVID-19 pandemic, concerns over availability have driven some—including Warp Speed chief Moncef Slaoui—to suggest tweaking dosing regimens to stretch out supplies. However FDA leadership came forward to say that any changes now would be premature, and could place the public health effort at risk. Meanwhile new treatments may be on the way, as scientists in China have used AI to identify an older chemotherapy drug they say could potentially outperform remdesivir. Those stories plus our top reads of the week and over the holiday break follow below. | |
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Featured Story | By Angus Liu Amid concerns over limited COVID-19 vaccine supplies, some have proposed tweaking the shots’ dosing to immunize more people. One suggestion came from none other than U.S. vaccine czar Moncef Slaoui. But the FDA’s stepping forward to dismiss the idea—at least for now. read more |
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Top Stories Of The Week By Ben Adams A new year and a new chief medical officer for Big Pharma Pfizer, as Mace Rothenberg announced via Twitter that he’s off to pastures new, with Pfizer tapping Stanford University’s Aida Habtezion to help run its R&D. read more By Beth Snyder Bulik Pfizer’s got a new blue. Two new blues in fact, with the company’s rebrand and new logo design. Gone is the staid blue oval pill background, replaced by a two-tone blue double helix spiral. The new logo signals Pfizer’s “shift from commerce to science. We’ve unlocked the pill form to reveal the core of what we do,” Pfizer explains on its website. read more By Angus Liu By using a combination of computational screening tools, scientists at the Chinese Academy of Sciences’ Shenzhen Institutes of Advanced Technology showed that Acrotech’s Folotyn, a chemotherapy originally developed to treat lymphoma, could potentially be repurposed to treat COVID-19. read more By Eric Sagonowsky Pharma's routine January price hikes are here once again—and not even a global pandemic seems to be slowing the number of increases. Amid ongoing scrutiny from politicians and the public, though, the level of many of the price hikes seems muted compared with previous years. read more By Eric Sagonowsky AstraZeneca's early COVID-19 trial data not only fell short of Pfizer and Moderna's expectation-beating stats, they raised a host of questions thanks to a dosing error in one group of trial patients. But with the U.K. suffering under a new viral strain and a quick vaccine approval expected, CEO Pascal Soriot says AZ has a new "winning formula." read more By Nick Paul Taylor Betsy Nabel is stepping down as the president of Brigham and Women’s Hospital to enter biotech. Nabel is reportedly set to join her husband, the former chief scientific officer of Sanofi, at a stealthy new biotech startup. read more By Conor Hale Senseonics’ plans to roll out its new, long-term diabetes sensor implant will be pushed to the middle of next year as FDA reviewers continue to be swamped by product submissions aimed at the COVID-19 pandemic. read more By Arlene Weintraub Regeneron CEO Leonard Schleifer and CSO George Yancopoulos just won rejigged performance-pay plans that promise a combined payday of up to $1.4 billion eight years from now. But their ability to nab those bonuses will rely on Regeneron's ability to grow market share for hits like Dupixent, while also getting novel drugs out of the pipeline. read more By Angus Liu For existing PD-1/L1 inhibitors, China represents an opportunity for new growth. But Merck, Bristol Myers Squibb, AstraZeneca and Roche have all failed to cut deals with the country's national drug reimbursement list, whereas domestic players won national coverage by offering whopping 80% discounts. read more By Ben Adams Just a few weeks after being snapped up by AstraZeneca, rare disease specialist Alexion has nabbed a priority review voucher from Rhythm that can speed up the approval of one of its late-stage meds. read more By Arlene Weintraub Canadian researchers discovered a state of “injury response” in the brain that's marked by signals of inflammation and immune activity and that can give rise to glioblastoma. They believe the details they uncovered about this phenomenon could be used to find better ways to target and kill glioblastoma cells. read more By Angus Liu For most of 2020, investors were placing bets on whether Bristol Myers Squibb would hit its targets to trigger a follow-up payment tied to its Celgene buyout. Short answer? It didn't. The FDA didn’t approve the CAR-T drug liso-cel by year-end as required—and disappointed investors might now channel their anger toward the company. read more By Conor Hale After COVID-19 testing sales pushed the company’s quarterly income to over $1.3 billion last year, Hologic is beginning to spend some of that cash—kicking off 2021 with a $64 million acquisition of a German manufacturer of breast cancer biopsy markers and guidance equipment. read more 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 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. | 
