WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST The FDA said it would need three more months to consider Cytokinetics’ heart failure therapy after getting their hands on additional data, pushing a decision into early 2023. Meanwhile, not content with a mere stake in Seagen, Merck is reportedly considering buying out the cancer-focused biotech. However a deal may not be imminent, and Merck may not be the only suitor. Merck, along with BMS and Pfizer, all face patent cliff exposure later this decade—but they also have the cash for major acquisitions to potentially head off the loss. Those stories, plus our other top reads of the week, follow below. | |
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Featured Story | By Annalee Armstrong The FDA needs more time to consider Cytokinetics’ omecamtiv mecarbil after getting a look at some additional data. read more |
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Top Stories Of The Week By Angus Liu Merck & Co. already owns a stake in antibody-drug conjugate specialist Seagen. But now, the New Jersey pharma appears to want the whole thing, according to The Wall Street Journal. read more By Annalee Armstrong In a moment of public reflection, the partners on Genentech's failed Alzheimer's disease therapy consider what happened, what they learned and what happens next. read more By Kevin Dunleavy Bristol Myers Squibb, Pfizer and Merck will face extreme patent cliff exposure later in this decade. But those companies also have the financial flexibility to strike mergers and acquisitions to address the anticipated losses, according to recent research from Moody's Investors Service. read more By Conor Hale Eli Lilly has joined forces with the digital therapeutics developer Sidekick Health to offer tailored apps that help patients with breast cancer stick to their medication regimens. read more By Zoey Becker As the industry sees more biosimilar uptake, Amgen says it's well prepared. Last week, the company presented a preview of its annual trends in biosimilars report at the BIO 2022 convention in San Diego. Next year, Amgen is planning to really make its mark with the industry's first US biosimilar of AbbVie's Humira. read more By Annalee Armstrong,James Waldron Galapagos CEO Paul Stoffels, M.D., has finally taken the plunge on M&A. The newly minted chief executive has signed not one but two deals in an attempt to right the ship, bringing two small biotechs aboard for a combined 239 million euros ($251.4 million). read more By Angus Liu A death risk signal has taken a toll on Clovis Oncology’s already lagging ovarian cancer drug, Rubraca. The company has taken FDA's hint, withdrawing the med in a late-line setting, but it remains undeterred in newly diagnosed patients despite an FDA warning. read more By Fraiser Kansteiner GSK has cut the ribbon at its new aseptic smart manufacturing plant in Barnard Castle, England, local news outlet Business Live reported Tuesday. Bankrolled by a £90 million ($110.45 million) investment, the facility—dubbed Q Block—will add another fixture to one of GSK’s biggest U.K. manufacturing sites, the publication said. read more By James Waldron Leukemia is notorious for being very aggressive and hard to eradicate from the body. The culprits are leukemic stem cells—known as “seed” cells—that drive resistance to chemotherapy and can trigger a relapse of the cancer. read more By Teresa Carey This week on "The Top Line," we discuss why scientists say we need an Alzheimer's moonshot. We also talk about a controversial take on a diversity during a panel at the BIO conference. Plus, we'll hear award-winning ads that tug at our heartstrings. read more Resources Sponsored by: Blue Matter, strategic consultants in the life sciences Medical Affairs plays a critical role in generating insights to inform strategic decisions, but that role is changing. This paper explores why, and how MA teams can stay ahead of the curve. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Sponsored By: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored By: Thermo Fisher Scientific Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. Sponsored by: Catalent Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Fierce Health Payer Summit October 12, 2022 | Free Virtual Event Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Drug Development Boot Camp® 2022 November 16-17, 2022 Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Free Virtual Event | 