Archive snapshot · Biotech
Fri, Oct 9, 9:32 PM ET
FDA approves Roche's Tecentriq with chemo for stage III dMMR colon cancer, cutting recurrence risk 50%
The label expansion makes atezolizumab plus chemotherapy the first immunotherapy regimen approved in this earlier-stage colon cancer setting, where a trial show
Pharmaceutical Executive · +14 outlets
Pfizer halts development of closely watched weight-loss drug
The move removes a late-stage contender from Pfizer's obesity pipeline as competition in the GLP-1 market intensifies.
www2.polskieradio.pl · +10 outlets
Novo Nordisk sues Hims & Hers over copycat weight-loss drugs
The lawsuit escalates the brand-versus-compounded GLP-1 dispute as regulators weigh broader compounding access.
www.polskieradio.pl · +13 outlets
Korea's first homegrown GLP-1 obesity drug, Hanmi's Eppe, wins domestic approval; shares swing
Eppe gives Korea a locally developed rival to Wegovy and Mounjaro, though investors questioned its weight-loss efficacy and pricing ahead of an October launch.
조선일보 · +9 outlets
Teva wins FDA approval for Weltruza, first once-monthly subcutaneous injectable olanzapine
The long-acting schizophrenia treatment avoids the pill burden and post-injection monitoring requirements associated with older olanzapine formulations.
Teva Pharmaceuticals · +7 outlets
PhRMA sues Trump administration over most-favored-nation Medicare drug pricing rule
The industry lobby argues the pricing model is unlawful overreach, setting up a legal fight over the scope of Medicare drug price controls.
DCAT Value Chain Insights · +14 outlets
India caps trade margins on cancer drugs at 30%, with MRPs seen falling up to 70%
The government's proposed margin cap on non-scheduled cancer medicines is welcomed by industry groups but raises questions about affordability versus sustainabi
NDTV · +13 outlets
Novartis wins FDA approval for Rhapsido label expansion in immunology
The approval broadens Novartis's immunology portfolio and drew analyst price-target updates on the stock.
The Globe and Mail · +13 outlets
Zealand and Roche's amylin weight-loss data impress on efficacy but spook on blood sugar
The mixed petrelintide results highlight safety questions for next-generation amylin-based obesity drugs even as their weight-loss profile draws interest.
Fierce Biotech · +1 outlets
Bayer's kidney disease drug application accepted by FDA for adults without diabetes
The filing targets a patient population beyond the diabetes-linked kidney disease indications that dominate current therapies.
Stock Titan · +14 outlets
ImmunityBio resubmits Anktiva application to FDA with additional data, stock declines
The resubmission revives the company's bladder cancer filing after a prior setback, with retail investors watching the stock closely.
Stocktwits · +5 outlets
Replimune shares surge as analyst raises melanoma approval odds after positive panel outcome
The FDA advisory panel's favorable vote could improve the path to approval for Replimune's melanoma therapy.
Stocktwits · +3 outlets
Eli Lilly leans on deals and new segments to extend obesity drug lead
The company is pursuing acquisitions and new indications to defend its position in the weight-loss market.
MedWatch · +2 outlets
Rocket Pharmaceuticals maps remaining steps for RP-A501 in Danon disease after clinical hold
The gene therapy developer is charting a path forward to resume its rare cardiac disease program following a regulatory hold.
BioPharm International · +1 outlets
FDA advisers narrowly vote to add 6 peptides to drug compounding list
The vote has implications for the availability of compounded peptide therapies, including weight-loss drugs.
PBS · +5 outlets
Newron provides update on FDA clinical hold and Phase 3 ENIGMA-TRS program
The company detailed next steps for its central nervous system candidate after the regulator paused the late-stage study.
The Manila Times
XORTX shares jump as gout drug program accelerates with Canadian testing
The company expects Canadian trial data to speed its planned U.S. gout drug application, lifting the stock.
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