ORG
Biotech Restructuring and European Regulatory Setbacks
LifeMine Therapeutics, layoffs, PTC Therapeutics, Translarna, Duchenne muscular dystrophy, European Commission, regulatory decision
FDA Shakeup: Peter Marks’ Resignation Rattles Biotech Industry
Peter Marks, FDA resignation, biotech stocks, regulatory uncertainty, drug approvals
CHMP recommends seven label expansions and one new approval, rejects Lilly Alzheimer’s drug
CHMP, Labels (device), expansions, Approved
FDA Rejects Milestone Pharmaceuticals’ Etripamil Nasal Spray for PSVT
Etripamil, Cardamyst, PSVT, FDA rejection, Complete Response Letter, manufacturing issues, Milestone Pharmaceuticals
Novo inks second obesity deal of the week, with Lexicon oral drug partnership worth up to $1B
Obesity, LX9851, lexicon, Mechanism (attribute)
BioNTech shows off lung cancer survival data behind phase 3 push for red-hot bispecific
BNT327, BioNTech, month, BioNTech ‘s, Small cell carcinoma of lung, Pharmacotherapy
BioAtla lays off 30% of staff, hunts out partners for ADC and cancer antibody
Staff, Partner in relationship, CAB, BioAtla, 30%
HHS Overhaul: RFK Jr. Cuts 20,000 Jobs in Major Restructuring
Robert F. Kennedy Jr., Department of Health and Human Services (HHS), job cuts, restructuring, Administration for a Healthy America (AHA), chronic disease epidemic, efficiency, cost-saving
FDA to Decide on Merck’s Subcutaneous Keytruda in September 2025
Subcutaneous Keytruda, FDA decision, September 23, 2025, Merck & Co., cancer treatment, PDUFA date