AbbVie wins FDA approval for Juvmo (tavapadon), a once-daily Parkinson's pill from its $8.7B Cerevel takeover
The approval gives AbbVie a new oral Parkinson's treatment sourced from its $8.7 billion Cerevel acquisition and validates a key pipeline bet.
STAT · +14 outlets
Merck and Daiichi Sankyo withdraw accelerated approval filing for lung cancer ADC ifinatamab deruxtecan after FDA pushback
The FDA said existing data would not support accelerated clearance, erasing an early edge the partners held in small cell lung cancer.
Biopharmadive · +14 outlets
Kodiak Sciences stock surges as eye drug matches Eylea in Phase 3, adding over $3B in market value
Positive late-stage results for tabirafusp suggest Kodiak could mount multiple challenges to Regeneron's Eylea franchise.
Biopharmadive · +8 outlets
FDA approves first gene therapy for Sanfilippo syndrome type A, a win for Ultragenyx after Angelman setback
The standard approval is the first gene therapy cleared for children with the rare neurodegenerative disorder.
progress.org.uk · +14 outlets
Summit Therapeutics shares surge after-hours on $2 billion AstraZeneca equity deal
The equity investment deepens ties between Summit and AstraZeneca in the competitive lung cancer drug space.
Yahoo! Finance Canada · +6 outlets
Merck licenses SciBrunch oral KRAS G12D inhibitor SPR2015 in deal worth up to $2.13 billion
The exclusive global license adds an oral KRAS G12D candidate to Merck's oncology pipeline in a hotly contested target class.
Yahoo Finance · +8 outlets
Merck discontinues antibiotic Recarbrio in the US despite superbug resistance concerns
The move removes a treatment option seen as important in the fight against drug-resistant infections.
STAT
Adicet Bio's off-the-shelf CAR-T shows lupus remissions in early trial, surpassing personalized CAR-T benchmarks
The early data signal potential for allogeneic cell therapy in autoimmune disease, where personalized CAR-Ts have shown promise.
Biopharmadive · +3 outlets
Mirum Pharma posts Phase 3 hepatitis win with challenger to Gilead and Vir treatments
The company frames the result as commercially differentiated as it targets the hepatitis B market.
Fierce Biotech
GLP-1 drugs increasingly marketed as lifestyle products for 'customers' rather than obesity patients
The shift in messaging raises questions about how blockbuster weight-loss medicines are positioned to the public.
STAT · +14 outlets
Scientists overcome cellular defenses against self-amplifying mRNA vaccines using a viral protein
The finding could improve next-generation vaccines that require smaller doses and offer broader protection.
Genetic Engineering and Biotechnology Ne · +13 outlets
FDA maintains clinical hold on Newron's Phase 3 ENIGMA-TRS trial of schizophrenia drug
The continued hold keeps patient enrollment paused and delays the program's path to late-stage data.
marketscreener.com · +6 outlets
Nonprofits' gene therapy for ultra-rare immune disease priced at $3.25 million
The price tag underscores the pricing challenges facing ultra-rare disease treatments even when developed by nonprofit groups.
Endpoints News
LIB Therapeutics and Sun Pharma sign global licensing and manufacturing deal for PCSK9 inhibitor lerodalcibep, approved in EU
The ex-US and China agreement pairs an EU-approved cholesterol drug with Sun Pharma's commercial and manufacturing reach.
BioSpace · +14 outlets
Scynexis wins $214M BARDA contract for antifungal development
Federal funding backs development of antifungals as drug-resistant fungal infections draw growing concern.
Fierce Biotech · +2 outlets
FDA approves Gazyva to reduce relapse risk in pediatric idiopathic nephrotic syndrome
The label expansion adds a new option for children with the kidney disorder.
AllSci · +7 outlets
Risk from toxic metals can persist months after wildfires, Maui study finds
The findings suggest post-wildfire air quality needs long-term monitoring, not just immediate testing.
STAT
FDA approves Atebrioz as third drug for rare FOP, a daily pill for patients 12 and older
The approval expands oral options for the ultra-rare bone disorder that causes abnormal bone growth.
inkl