Archive snapshot · Biotech
Thu, Oct 29, 4:03 AM ET
Lilly says retatrutide beat Ozempic on blood sugar and weight in diabetes trial
The head-to-head data boost expectations for Lilly's 'triple-G' drug as a major growth driver, though higher side-effect rates and discontinuations were reporte
STAT · +13 outlets
Personalized mRNA melanoma vaccine cuts recurrence or death risk by 42% in phase 3
The positive trial data mark the first major success for an individualized cancer vaccine and spur efforts to expand the approach.
Oncology News Central · +14 outlets
Genmab's bispecific combo halves risk of death in phase 3, validating $8B Merus bet
The late-stage win supports Genmab's multibillion-dollar acquisition of Merus and lifts its shares.
Fierce Biotech · +2 outlets
FDA unveils draft guidance to speed approval of individualized gene editing therapies
The framework creates a 'plug and play' pathway for patient-specific therapies and draws praise from rare disease advocates.
Biopharmadive · +10 outlets
FDA and CMS announce joint steps to advance gene therapies and expand rare disease access
The agencies are coordinating on policy to widen access to personalized treatments for rare diseases.
HHS.gov · +4 outlets
Astellas bets up to $1.34B (A$2B) on Melbourne startup's cancer candidate
The deal hands Astellas rights to a Melbourne-developed cancer therapy it calls potentially best-in-class.
BiotechDispatch · +2 outlets
Artiva shuts down after two patient deaths in autoimmune cell therapy trial
The closure is the third recent report of fatal events in autoimmune cell therapy trials, following Novartis and BMS.
STAT · +11 outlets
FDA approves GSK's functional cure for hepatitis B
The approval adds a new functional cure option for chronic hepatitis B.
Drug Discovery News · +14 outlets
Judge rejects Novo bid to block Lilly obesity drug advertising
The ruling found Novo failed to prove Lilly's superiority claims meaningfully harmed Wegovy sales.
Biopharmadive · +13 outlets
FDA approves Rasonque for previously treated advanced pancreatic cancer
The approval gives a new option for advanced pancreatic cancer patients who have already received treatment.
Denkstrom · +13 outlets
Kelun-Biotech wins China NMPA review for sac-TMT plus pembrolizumab in first-line lung cancer
The combination moves toward possible approval in China for first-line lung cancer.
BioPharma APAC · +7 outlets
HHS moves to allow compounding of some unapproved peptides after FDA advisers' narrow vote
The policy reflects MAHA movement interest in peptides despite limited evidence for many wellness compounds.
STAT · +13 outlets
Ferring to acquire next-gen IVF startup Gameto for up to $1.4B
The buyout gives Ferring rights to technology aimed at simplifying in vitro fertilization.
Biopharmadive · +3 outlets
Merck drug extends survival in endometrial cancer trial, wins US priority review
The survival benefit and priority review move the Merck therapy closer to approval.
The Hindu · +5 outlets
House lawmaker asks GAO to probe TrumpRx drug savings claims
The request questions whether the TrumpRx platform has saved Americans any money on prescription drugs.
STAT · +2 outlets
STAT investigation: Epic's EHR dominance is choking health tech innovation
The investigation found Epic selectively withholds patient data access, disadvantaging rival developers and drawing antitrust scrutiny.
STAT · +2 outlets
Missouri AG warns Lilly to stop requiring hospital claims data for 340B discounts
The warning signals growing state pushback against drugmaker conditions on 340B discounted medicines.
STAT · +1 outlets
HUTCHMED drug gets rare-disease status, could win 7 years of US exclusivity
The designation could grant seven years of US market exclusivity for the drug if approved.
Stock Titan · +2 outlets

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