WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST A chunk of Pfizer’s plan to add $15 billion in sales went up in smoke after the big pharma decided to hand the rights to the cardiovascular drug vupanorsen back to Ionis. Once slated to deliver peak sales of more than $3 billion, a deeper dive into phase 2b data exposed weaknesses after top-line results late last year were mostly positive. Meanwhile, after Biogen chief Michel Vounatsos called on Aduhelm supporters to fight Medicare’s restrictive coverage proposal last month, the agency received three times as many public comments going the other way, questioning the benefits of the Alzheimer’s drug. Those stories, plus Fierce’s other top reads of the week, follow below. | |
|
Featured Story | By Nick Paul Taylor A big chunk of Pfizer’s plan to add $15 billion to sales just went up in smoke. Having gone over phase 2b data on cardiovascular drug vupanorsen, Pfizer has decided to return the rights to Ionis Pharmaceuticals, leaving it without a candidate it tipped to deliver peak sales of more than $3 billion. read more |
| |
|---|
|
Top Stories Of The Week By Fraiser Kansteiner Despite Biogen and certain Alzheimer's advocacy groups' opposition, the public seems to support the Centers for Medicare & Medicaid Services' restrictive coverage decision on controversial Alzheimer's disease drug Aduhelm. read more By Annalee Armstrong Gilead revealed that a partial clinical hold for its CD47 targeted cancer hopeful is larger than originally thought. Disclosed in the fine print of the pharma giant’s fourth-quarter earnings presentation Tuesday was that two more studies are subject to the hold, bringing the total number of affected trials to seven. read more By Fraiser Kansteiner Two Biogen board members, Nancy Leaming and Brian Posner, will retire next month. Meanwhile, the company continues to weather the rocky launch of its controversial Alzheimer's disease med Aduhelm. read more By Ben Adams Neurologists in the U.S. are agreeing with a new draft decision from the Centers for Medicare & Medicaid Services (CMS) that restricts reimbursement of Biogen’s controversial Alzheimer’s drug, Aduhelm, to clinical trials only. In fact, half of those surveyed said CMS' decision would hit how they prescribe the rival drugs waiting in the wings that are also included in CMS' decision. read more By Nick Paul Taylor Takeda keeps pumping out biotech spinoffs. Months after spawning HilleVax, the Japanese drugmaker has packed off another pair of midphase programs to seed a new rare disease player: Oak Hill Bio. read more By Andrea Park They say you have to spend money to make money, and that definitely proved true for Thermo Fisher Scientific in 2021. read more By Kevin Dunleavy With a Jan. 30 target date fast approaching for approval of Libtayo as a second-line treatment in cervical cancer, Regeneron and Sanofi have voluntarily withdrawn their application. The companies and the FDA were not “able to align on certain post-marketing studies," Regeneron and Sanofi said. read more By Fraiser Kansteiner Eli Lilly has designs on a new biologics factory in Ireland. It's investing some $445 million in the plant, with plans to hire 300 full-time staffers once the facility is complete. Details on the work planned for the site are slim, but Lilly made a point to say the facility will support its Alzheimer's portfolio, currently led by potential Aduhelm rival donanemab. read more By Angus Liu The hallucination side effect has stalled the use of psychedelics such as LSD and psilocybin from “magic mushrooms” to treat depression. Now, scientists in China have offered new insights into the drugs' activity and designed LSD analogs that appear to have solved the hallucination problem. read more Resources Sponsored by: Blue Matter, strategic consultants in the life sciences What’s in store for the CNS therapeutics market in 2022? This paper looks ahead in Alzheimer’s, Parkinson’s, DMD, psychiatric disorders, pain, and more. Sponsored by: Thermo Fisher Scientific Learn how a CDMO partnered with Thermo Fisher Scientific to manage high-volume process liquid and buffer preparation scale-up. Download the free case study from Thermo Fisher Scientific Sponsored by: Thermo Fisher Scientific A variety of genetic analysis methods are valuable in ensuring that ex vivo human cells to be used for cell-based therapies are correctly identified, have the correct characteristics, and are free of contaminants. Sponsored by: IQVIA Learn how to elevate your omnichannel marketing strategy with Next Best - a combination of data and analytics, deployed to facilitate decision making. Sponsored by: Catalent Biologics Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. | 