WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST Biogen and the drug pricing watchdogs at ICER went back-and-forth over whether Aduhelm provides benefits over the current standard for Alzheimer’s disease, and whether those benefits are worth the money. They disagreed. Though the drugmaker said “innovative thinking” would be needed to fully assess the treatment’s value and its $56,000 annual price tag, ICER’s panel voted unanimously against the drug. But that’s not stopping the company’s new, high-profile ad campaign urging people to get screened for Alzheimer’s at the first signs of cognitive impairment—even while certain hospital systems, such as the Cleveland Clinic, say they won’t administer the drug themselves. Those stories, plus the big changes planned for GSK and Regeneron’s R&D sites, follow below. | |
| Featured Story By Noah Higgins-Dunn With Aduhelm facing troubles with prescribers, Biogen and Japanese partner Eisai are pushing a new Alzheimer's ad campaign focused on the importance of early disease detection. read more |
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| | eBook: Drug Design and the Patient Journey Patient-focused drug design can be a key factor in real-world therapeutic outcomes and business success. But if successful treatments should be created with patients in mind, when is the optimal time to solicit this feedback? This eBook features insights from experts in the industry on patient-centric drug development challenges and strategies on advancing drug design and development effectively. Learn more. | Top Stories Of The Week By Noah Higgins-Dunn In a stinging rebuke against Biogen's Alzheimer's drug Aduhelm, a group of independent experts with U.S. cost watchdog ICER issued a 15-to-0 vote against the treatment. Biogen brought its own set of arguments to the meeting but was unable to convince the group. read more By Nick Paul Taylor GlaxoSmithKline is planning to sell more than one-third of its 92-acre R&D site in Stevenage, U.K. The proposed sale, which comes amid criticism of GSK’s historically low R&D investment, is part of a plan to turn part of the site into a life science campus. read more By Fraiser Kansteiner Regeneron laid plans for a six-year, $1.8 billion expansion at its existing Westchester County campus, according to the New York Governor’s office. The expansion will see the company grow its New York headcount by 1,000 over the next five years. read more By Fraiser Kansteiner Pfizer, which put global Chantix distribution on hold late last month, is escalating its response to discovering a potential cancer-causing agent in the drug. The latest development involves as 12-lot recall of a drug that's already in shortage. read more By Amirah Al Idrus Months after finally revealing its first weapons against cancer, Erasca has pulled off a $300 million IPO. The proceeds will propel an SHP2 inhibitor and an ERK inhibitor through the clinic and get at least one more prospect into human trials. read more By Noah Higgins-Dunn AbbVie and Eli Lilly said separately that the FDA again delayed decisions over their applications for Rinvoq and Olumiant for adults and adolescents with moderate to severe atopic dermatitis. read more By Arlene Weintraub The protein produced by the gene HTRA1 naturally increases with age and has long been thought to contribute to age-related macular degeneration (AMD) and other diseases of aging. But researchers at University of Utah Health believe that in some cases, the HTRA1 protein might be protective, not destructive—and augmenting it could be a new treatment strategy. read more By Kevin Dunleavy Facing astronomical costs over talc lawsuits, Johnson & Johnson is exploring the possibility of starting a new company to absorb the litigation liabilities and declare bankruptcy, according to Reuters. read more By Conor Hale Velano’s PIVO device, first cleared by the FDA in 2017, collects blood painlessly after the initial placement of an IV line. read more | Executive Summary: Are Real-time Gene Therapy Results Possible? As science and tech companies continue to make advancements in vaccine and viral vector-based gene therapy development, there is an increasing need for analytical techniques to help assess quality parameters, especially in real-time. Download this Executive Summary to learn how Catalent applied more rapid and accurate measurement of quality attributes—such as viral titer and infectivity—to cell testing. | Resources Sponsored by: Patheon by Thermo Fisher Scientific Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: Blue Matter Consulting E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic. Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: PA Consulting What does the future of Cell & Gene Therapy look like? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored By: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. 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. |