VC biotech funding drops 46% in first quarter as firms guard against bear market Déjà vu: FDA rejects NRx filing for emergency use in COVID-19 Otsuka pays Akebia $55M to exit anemia pill pacts amid dispute and FDA rejection Provention's embattled diabetes med delayed again by FDA to consider new info Hit with 'current market realities,' Heron axes more than a 3rd of 300-person workforce Fierce Next Gen: Eikon drops hints at early pipeline, plans for $660M-plus reservoir 'The Top Line' podcast: FDA's coming COVID shot makeover, what's driving new M&A activity, plus this week's headlines FDA recommends Pfizer, Moderna update their COVID boosters to target omicron subvariants HHS issues guidance on patient privacy in wake of SCOTUS abortion ruling MMS set for expansion under new private equity backer Lindsay Goldberg Intuitive, Siemens score FDA nod to add 3D imaging to robotic lung biopsies Blueprint rounds up $1.25B to grow cancer portfolio through internal R&D and dealmaking Chutes & Ladders—FDA fortifies executive team with 2 new hires, including a chief scientist Fierce Pharma Asia—Astellas' gene therapy setback and new partnerships; Fujifilm's $1.6B expansion Featured Story | By Annalee Armstrong Just when biotechs could use cash the most, the well has dried up. Venture financing deal value for U.S.-based biotechs fell by 46% in the first quarter, compared to the same period a year ago, according to GlobalData. read more |
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Top Stories By Nick Paul Taylor Aviptadil has gone 0 for 2 on emergency use authorization filings at the FDA. The new rejection is the latest in a series of blows to the COVID-19 candidate, driving NRx Pharmaceuticals to shift focus to its bipolar depression prospect. read more By Nick Paul Taylor Akebia Therapeutics has extracted one final payday from Otsuka Pharmaceutical. With Otsuka cutting its ties to oral anemia drug vadadustat in the wake of rejection by the FDA, Akebia has secured a $55 million settlement, sending its bargain basement share price up 50% in after-hours trading. read more By Gabrielle Masson Provention Bio thought the resubmission for its diabetes prevention drug teplizumab was in the clear. But now, the FDA needs more time for the application after getting a look at some new information. read more By Gabrielle Masson Heron Therapeutics has joined the gaggle of biotechs laying off staff, cutting a third of its workforce as part of restructuring efforts that could bring an annual $43 million in savings. read more By Max Bayer After raising more than $660 million in less than a year, Eikon Therapeutics' future plans are coming into clearer view, with an oncology pipeline underway as the star-studded biotech looks to capitalize on—and expand—Nobel Prize-winning tech. read more By Teresa Carey This week on "The Top Line," we discuss what FDA advisors want added to future COVID vaccine doses—and why. Also, experts predict an uptick in dealmaking, particularly for a few key companies. read more By Zoey Becker After the FDA's independent vaccine committee voted to update COVID-19 shots, the agency recommends that manufactures update their vaccines to target omicron subvariants BA.4 and BA.5. read more By Heather Landi Healthcare providers are not permitted to disclose patient health information unless faced with a court order, including information relating to abortion and other sexual and reproductive health care, HHS said Wednesday. read more By Gareth Macdonald Private equity firm Lindsay Goldberg has invested in Michigan-based contract research firm MMS as new therapeutic modalities drive growth in the drug development industry—particularly cell and gene therapies. read more By Andrea Park Too many cooks in the kitchen may spoil the broth, but medtech developers are betting that adding increasingly more tech tools to the operating room will only improve procedure success rates. read more By Angus Liu Blueprint Medicines is “converting future revenue to cash,” as CEO Kate Haviland put it. The company is selling royalties to its targeted cancer drugs Ayvakit and Roche-partnered Gavreto and securing additional money for future dealmaking. read more By Max Bayer The FDA has shored up its executive team, naming both a chief scientist and chief medical officer. GSK has scooped up a couple of dealmakers from AstraZeneca. Biopharma veteran Huang joins upstart biotech backed by Novarits. read more By Angus Liu Astellas hit another gene therapy clinical hold, but the Japanese pharma signed two partnerships focused on novel antibody-drug conjugate technology and undruggable targets. Fujifilm is pouring $1.6 billion to bolster its cell culture manufacturing services. And more. read more Resources Sponsored by: Lumanity Check out our 22 on-demand panels, featuring 100+ speakers. Tap into discussions of scientific progress in oncology around development, regulatory, clinical, commercial and investment perspectives. 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