Late Friday approval; Trio of biotechs wind down; Stem cell pioneer finds new frontier; Biotech icon to retire; and more

28 Jan 2023
endpts.com
VaccinePhase 3
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here . I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities. News of several biotechs shuttering came out this week. A small player looking to carve a lane in the tRNA field by the name of Theonys has folded , Kyle LaHucik reports, due to disagreements between investors, although the scientific co-founder hinted the work may be continued elsewhere. Xenikos , a 13-year-old Dutch biotech, is going through a liquidation process after disappointing results in its Phase III trial in graft-versus-host disease. Then kidney-focused Goldfinch Bio confirmed it’s the latest to shut down . Thirty-five years after the first cell therapy company she worked for went under, stem cell pioneer Jeanne Loring is still pushing for more recognition for the setback-ridden field — and she’s making another shot using a unique approach that’s set to enter the clinic soon. Endpoints features editor Jared Whitlock takes a long look back at her career just as she marked another special moment: sending her cells into space. George Scangos , one of the all-time great biotech CEOs, says the time has come to turn over the reins one last time. After spending close to three decades in a CEO post, the 74-year-old biotech legend is handing the Vir Biotechnology keys to Marianne De Backer , one of the most prominent BD chiefs in the business currently at Bayer . He talks to Endpoints founding editor John Carroll about the “complicated” decision. Newly released FDA emails shed new light on a series of vigorous exchanges among top officials, including how the top vaccine leader raised concerns that a sharply accelerated process to review and formally approve Pfizer’s Covid-19 vaccineCovid-19 vaccine would undermine public confidence in the shots. Endpoints senior editor Zach Brennan distilled the biggest takeaways from well over 100 pages of internal documents. Eli Lilly succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitorsBTK, inhibitors to market, pushing it past rival Merck. The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma. Amid frequent chatter about R&D layoffs as biotechs of all stripes seek longer runways, buzz about a burst of Bristol Myers Squibb resumes hitting the market out of New Jersey drew some special attention. Endpoints’ John Carroll got an answer — but the company isn’t saying much. PREMIUM For those who missed our events at #JPM23, we have some more video recaps and transcripts for you: PEOPLE DEALS CELL/GENE TX CORONAVIRUS PHARMA R&D FINANCING STARTUPS LAW MARKETINGRX FDA+ MANUFACTURING DON’T MISS
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