FDA places partial clinical hold on Biohaven/SK Biopharma epilepsy drug opakalim (OPCALIM) over toxicity concerns
The partial hold affects a study analysts see as necessary to support a potential approval, and comes weeks after Biohaven sold off rights to the therapy.
Biopharmadive · +4 outlets
Moderna and Merck's mRNA melanoma vaccine meets Phase 3 endpoints, improving survival with Keytruda
A positive Phase 3 readout would mark a landmark for adjuvant melanoma treatment and for mRNA cancer vaccine development more broadly.
streamlinefeed.co.ke · +14 outlets
Novartis hit by trial setbacks: muscular dystrophy AOC drug fails, shares fall, investor seeks board shake-up
A major shareholder called for a board shake-up after the drugmaker's shares suffered a record fall following the trial setbacks.
STAT · +4 outlets
FDA clears Bayer's Hyrnuo (sevabertinib) in first-line HER2-mutated NSCLC, intensifying Hernexeos rivalry
The approval expands Bayer's lung cancer portfolio into first-line targeted therapy for HER2-mutated non-small cell lung cancer.
STAT · +2 outlets
FDA approves breakthrough drug for advanced pancreatic cancer, with MD Anderson involved in the trial
The approval adds a new option for advanced pancreatic cancer, a disease with historically poor treatment outcomes.
The Business Journals · +13 outlets
Solstice Oncology launches with $225M Series A to advance next-gen CTLA-4 drug from China's Harbour BioMed
The startup, led by a former Mural Oncology CEO, aims to address weaknesses of existing drugs targeting the popular but tricky CTLA-4 cancer immunotherapy targe
Biopharmadive · +9 outlets
Kura Oncology spins diabetes work into Lilly-backed startup Caspian with $50M
Caspian Therapeutics will develop menin inhibitors, effective against leukemia, for diabetes and other cardiometabolic conditions.
Biopharmadive · +3 outlets
FDA accepts Nanoscope's BLA for optogenetic gene therapy MOGENRY in retinitis pigmentosa
The acceptance moves Nanoscope's vision-restoring gene therapy closer to a potential approval decision for severe vision loss.
Glance by Eyes On Eyecare · +5 outlets
Mikhail and Davis named permanent CBER and CDER directors, giving FDA leadership continuity
The appointments follow almost two years of turnover in the FDA's top ranks and may ease concerns about further turmoil.
Biopharmadive · +11 outlets
BrainChild Bio raises $116M to advance CAR T therapy for childhood brain cancer
The Seattle biotech's funding supports clinical development of CAR T treatment for pediatric brain tumors.
GeekWire · +11 outlets
Encoded Therapeutics gains $275M to advance Dravet syndrome drug and scale genetic medicine manufacturing
The GV-backed gene therapy developer will use the funds for its Dravet syndrome program and manufacturing capacity.
Fierce Biotech · +5 outlets
Biohaven, uniQure and others: UniQure's Huntington's gene therapy four-year readout expected by end of September
The closely tracked Phase 1/2 data will test the durability of benefit for uniQure's Huntington's disease gene therapy.
STAT · +5 outlets
FDA grants priority review to Roche's Enspryng for MOGAD
Priority review shortens the FDA's assessment timeline for Roche's drug in the rare autoimmune disorder MOG antibody disease.
The Clinical Trial Vanguard · +7 outlets
FDA advisers narrowly vote to add 6 peptides to drug compounding list
The narrow advisory vote shapes which peptides compounding pharmacies may continue to produce amid ongoing regulatory debate.
PBS · +9 outlets
In first interview as FDA oncology chief, Angelo de Claro vows to continue OCE's innovation legacy
The new head of the FDA's Oncology Center of Excellence outlines priorities for cancer drug regulation.
Fierce Pharma · +1 outlets
Tyra Biosciences' bladder cancer data disappoints investors, but company moves toward pivotal study
Phase 2 remission rates fell short of Wall Street expectations, though some analysts expect better results in late-stage testing.
Biopharmadive · +4 outlets
AstraZeneca drug cuts COPD flare-ups in two late-stage trials, with megadeal speculation swirling
The COPD win comes as biotech investors look for a rebound after a brutal July and speculation builds about an AstraZeneca-Bristol Myers deal.
STAT
Insilico Medicine begins Phase 3 trial of AI-discovered drug rentosertib for IPF
The milestone tests whether AI-driven drug discovery can deliver a late-stage candidate in idiopathic pulmonary fibrosis.
The Clinical Trial Vanguard