Lilly's retatrutide beats Ozempic on blood sugar and weight loss in Phase 3 diabetes trial
The triple-G drug produced roughly double the weight loss of Novo Nordisk's Ozempic at its highest dose, though with more side effects and discontinuations.
Biopharmadive · +12 outlets
Genmab soars to record high as Merus bispecific halves death risk in head and neck cancer trial
Positive Phase 3 results for the recently acquired antibody added more than $7 billion to Genmab's market value, with the drug potentially becoming a new standa
Biopharmadive · +5 outlets
FDA issues draft guidance to speed approval of personalized gene editing therapies for rare diseases
The framework would let a single approval cover multiple patient-specific therapies, a shift regulators say could accelerate access for rare disease patients.
Biopharmadive · +13 outlets
Personalized mRNA cancer vaccine cuts melanoma recurrence or death by 42% in Phase 3
The mRNA vaccine combined with Keytruda showed improved recurrence-free survival, results researchers called a major step for personalized cancer immunotherapy.
Oncology News Central · +14 outlets
HHS lets compounders make six unapproved peptides, despite FDA scientist objections
RFK Jr.'s enforcement-discretion policy gives a regulatory boost to the peptide wellness craze over concerns from career FDA staff about limited evidence.
Biopharmadive · +7 outlets
Labor Department finalizes rule forcing pharmacy benefit managers to disclose fees
Starting in 2027, PBMs must share compensation data with self-funded employer clients, a change employers praised and the industry called government overreach.
Biopharmadive · +14 outlets
China's cheap, rapid human trials upend global drug development
The country's growing stature in clinical research is reshaping how multinationals source trials and licensing deals.
Bloomberg.com · +2 outlets
Aspen Neuroscience raises $140M IPO for Parkinson's cell therapy
The San Diego startup is among several firms pursuing cell therapy to slow or halt the neurodegenerative condition.
Biopharmadive · +2 outlets
California biotech lays off nearly all staff after trial deaths; cell therapy scrapped
Two patient deaths in a trial led to the program's discontinuation and the loss of 94% of staff.
The Mercury News · +7 outlets
Vertex kidney disease drug scrutinized for infection risk ahead of Nov 30 FDA decision
Reviewers and investors are weighing safety concerns before the regulator rules on the therapy.
STAT · +2 outlets
Dren Bio lands $350M to push rare blood cancer therapy toward market
The financing backs late-stage development of a bispecific antibody for a rare hematologic malignancy.
BioSpace · +1 outlets
Flagship merges three biotech startups into AI-aided drugmaker Etcelera
Etiome, Cellarity and Empress Therapeutics are being combined into a company claiming better prediction of how medicines will fare in humans.
Biopharmadive · +2 outlets
Iovance stock crashes on surprise lung cancer trial setback
The top-ranked biotech stock fell sharply after an unexpected result in a lung cancer study.
Investor's Business Daily
FDA approves GSK's functional cure for hepatitis B
The approval marks a new option for chronic hepatitis B, a condition affecting hundreds of millions worldwide.
Drug Discovery News · +14 outlets
FDA enforces long-awaited trial result transparency rules
The move requires sponsors to post results from completed trials, addressing years of criticism over missing data.
Undark Magazine · +2 outlets
Revolution Medicines wins FDA nod for $39,800-a-month pancreatic cancer pill
The approval of Rasonque for previously treated advanced pancreatic cancer drew scrutiny over its monthly price.
Stocktwits · +6 outlets
FDA approves first-ever drug for a rare neurological disorder after 30 years
The approval ends a decades-long drought for patients with the rare condition.
ScienceAlert
Merck to lift next-decade revenue forecast on new drug optimism
The guidance targets growth as the company works past key patent expirations, with another cliff looming.
KELO-AM