Zymeworks rejects All Blue's $773M offer as an 'opportunistic' public attack Sanofi's Xenpozyme, Lilly's Olumiant among batch of new EU approvals FDA denies NeuroOne's bid to extend brain-monitoring electrode use past 24 hours Startup Tia moving into fertility services as part of integrated women's health care Bayer pulls plug on $670M CAR-T cell therapy pact with Atara in wake of patient death 'The Top Line' podcast: The aftermath of Roche's failed TIGIT, Big Pharma's Q1 growth vs. mRNA stars, plus this week's headlines iCAD’s 3D mammography AI catches more breast cancers in real-world study Judge strikes down CMS' Medicaid copay rule, handing PhRMA major win 100% overall survival data for gene therapy fuel Rocket for flight to regulators Novartis hands over Tasigna patent as part of coalition with Roche, BMS and more to boost cancer drug access in poor countries Death triggers FDA hold on Foghorn blood cancer clinical trial, shrouding timing of data drop MeMD rebrands as Walmart Health Virtual Care Featured Story | By Max Bayer Zymeworks is nixing a $773 million offer from shareholder All Blue Capital to buy the company, saying the proposal “lacks credibility,” was “opportunistic” and ultimately, undervalues the company. read more |
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Top Stories By Kevin Dunleavy Following the FDA’s familiar playbook with a flurry of Friday afternoon approvals, the European Medicines Agency has signed off on several drugs, including Sanofi’s Xenpozyme, an enzyme replacement therapy for acid sphingomyelinase deficiency and Eli Lilly and Incyte’s Olumiant for alopecia areata. read more By Andrea Park In the May 13 letter, the FDA upheld its initial decision to limit the Evo sEEG system’s use to just 24 hours at a time, noting that the company’s supporting evidence failed to prove that the device was substantially equivalent to other electrodes that have been cleared for longer wear periods. read more By Heather Landi Women's health startup Tia is expanding its integrated care model to include fertility services with a focus on connecting family planning with counseling, preventive care and mental health support. read more By Nick Paul Taylor Bayer is pulling the plug on its $670 million CAR-T pact with Atara Biotherapeutics. Three months after a death paused a study of the lead candidate, the German drugmaker has decided to cut its ties to Atara’s two mesothelin-directed CAR-T cell therapies. read more By Teresa Carey This week on "The Top Line," we discuss what's left in the wake of Roche’s failed high-risk bet on an anti-TIGIT cancer drug. We also talk about Big Pharma’s growth in the first quarter and the week's biggest headlines. Plus, Fierce journalists share what it was like to finally be in a newsroom together again. read more By Conor Hale iCAD’s ProFound program was one of the first pieces of AI cleared by the FDA for 3D mammography, an imaging method also referred to as digital breast tomosynthesis or DBT. read more By Robert King A federal judge struck down a controversial Trump-era rule that required mandated drug makers to include copay assistance costs into Medicaid drug rebate calculations. read more By Annalee Armstrong One hundred percent overall survival in just seven patients has provided the jet fuel needed by Rocket Pharmaceuticals to head to regulators for a rare childhood immunodeficiency disorder gene therapy. The company unveiled the phase 2 pivotal results from patients with severe leukocyte adhesion deficiency-I at the 25th Annual Meeting of the American Society of Gene and Cell Therapy Thursday. read more By Angus Liu Several large pharma companies have joined hands with global health organizations in a new partnership that aims to improve access to essential cancer medicines in poorer nations. read more By Nick Paul Taylor The FDA has sounded a warning about Foghorn Therapeutics’ blood cancer candidate FHD-286, putting a phase 1 clinical trial on a partial hold in response to the death of a patient with potential differentiation syndrome. read more By Paige Minemyer Telehealth provider MeMD is changing its name to Walmart Health Virtual Care, marking one of the final steps in its integration into the retail giant's healthcare enterprise. read more |
