Merck's Welireg scores FDA nod in cancers spurred by rare disease—and its label is broader than expected Ipsen pulls FDA rare disease filing, dealing yet another blow to $1B bet on rare disease drug Teladoc, Epic and Intermountain execs share their thoughts on HIMSS21 and why they made the trek to Las Vegas FDA veteran and outspoken expert Unger retires as the agency finds itself at a crossroads FDA denies Rigel's COVID-19 hopeful Tavalisse for hospitalized patients, asks for late-stage data Amwell expects fewer telehealth visits in fall, winter as delta variant creates uncertainty Ogilvy Health's new PR practice chief talks pharma image and social trends CMS outlines reforms to benchmarks, financial incentives to entice providers to participate in models Chutes & Ladders—Merck's Vaxneuvance lead exits to make rival vaccine at Affinivax COVID-19 tracker: San Francisco, New Orleans require vaccines or negative tests at indoor businesses Featured Story | By Noah Higgins-Dunn Belzutifan, now sold as Welireg, snared its first FDA approval on Friday for patients with a number of cancers associated with the rare disorder known as von Hippel-Lindau disease. The agency’s decision comes a month ahead of its expected decision date, and its label is broader than what some analysts expected. read more |
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Top Stories By Nick Paul Taylor The curse of palovarotene continues. After struggling through a series of setbacks, Ipsen filed for FDA approval of the rare disease drug earlier this year, moving it a step closer to realizing some return on its $1 billion bet on the asset. Now, Ipsen has pulled the filing. read more By Dave Muoio,Heather Landi They came for the vaccine mandate and they stayed for the face-to-face (albeit masked) networking. Here’s what executives had to say about their reasons for attending the 2021 HIMSS Global Conference and Exhibition and how they strategized their presence at the show. read more By Amirah Al Idrus The FDA is losing a top official as the search for its new commissioner drags on. Ellis Unger, M.D., a cardiologist who led the agency’s Office of Drug Evaluation I, is retiring after 25 years at the agency. read more By Angus Liu The FDA has authorized a few of drugs for emergency use in hospitalized COVID-19 patients, but Rigel Pharmaceuticals’ autoimmune disease drug Tavalisse won’t be joining the group right now. read more By Heather Landi As the delta variant continues to drive the nation's latest coronavirus surge, Amwell expects fewer telehealth visits through the fall and winter. The telehealth giant is projecting an $8 million impact on its 2021 revenue as a result of the drop in projected virtual care visits. read more By Beth Snyder Bulik Shannon Walsh, recently tapped to lead the public relations practice at Ogilvy Health, talks about the pharma industry PR shift now underway from image to impact, along with other trends in the field, in a recent discussion with Fierce Pharma. read more By Robert King CMS laid out a new vision for value-based care models that aims to ensure providers don't lose money in a bid to entice more participation. read more By Kyle LaHucik Merck is losing the person who led clinical development of its pneumococcal conjugate vaccine Vaxneuvance as Kara Bickham, M.D., picks up the CMO role at Affinivax to bring a rival shot to market. read more By Noah Higgins-Dunn,Kevin Dunleavy,Fraiser Kansteiner New Orleans and San Francisco will require patrons of restaurants, gyms and other indoor businesses to show proof of vaccination before entering. CDC advisors are scheduled to meet later on Friday to discuss the need for booster shots following the FDA's move to authorize the jabs for immunocompromised Americans. Plus more headlines. read more |
