Biomedical or Dental Material
AbbVie Buys Gilgamesh’s Psychedelic Drug Bretisilocin for $1.2B
AbbVie; Gilgamesh Pharmaceuticals; psychedelic drug; bretisilocin; GM-2505; major depressive disorder; acquisition; mental health; neuroscience; pharmaceutical deal
IO Biotech’s cancer vaccine Cylembio narrowly misses Phase III primary endpoint in advanced melanoma, but company eyes FDA filing in 2025
Cylembio; IO Biotech; melanoma; Phase 3; pivotal trial; progression-free survival (PFS); hazard ratio 0.77; p-value 0.056; Keytruda (pembrolizumab); FDA BLA; overall survival (OS) trend; IOB-013/KN-D18; NCT05155254; imsapepimut; etimupepimut; stock drop
XtalPi and DoveTree Announce Landmark $6 Billion AI-Powered Drug Discovery Collaboration
XtalPi; DoveTree Medicines; AI drug discovery; robotics; pharmaceutical R&D; Gregory Verdine; oncology; immunology; neurology; metabolic diseases; collaboration; upfront payment; milestone payments; royalties
FDA Approves LENZ Therapeutics’ VIZZ Eye Drop for Presbyopia
FDA approval; VIZZ; LENZ Therapeutics; presbyopia; aceclidine; eye drop; near vision
Novo Nordisk’s Leadership Shakeup and Wider Implications; Ex-FDA Official Takes Regulatory Role at GSK
Novo Nordisk; leadership shakeup; new CEO; Maziar Mike Doustdar; share price drop; obesity drug market; competition; GSK; regulatory affairs; Former FDA
Ignoring China’s Biotech Industry Is No Longer an Option: Recent Developments and Implications
China biotech industry; global drug development; clinical trials; innovation ecosystem; pharmaceutical R&D; biotech patents; US-China competition
Viridian Licenses Promising Eye Disease Candidates to Kissei for Japanese Market
Viridian Therapeutics; Kissei Pharmaceutical; veligrotug; VRDN-003; thyroid eye disease; Japan partnership; anti-IGF-1R antibodies; clinical trials; biopharma deal
Bausch Health to Acquire DURECT and Breakthrough Liver Disease Candidate Larsucosterol for $63M Upfront
Bausch Health; DURECT; larsucosterol; liver disease; alcoholic hepatitis; epigenetic modulator; FDA Breakthrough Therapy; acquisition; pharmaceutical; milestone payments
FDA Investigates Elevidys Death; Sarepta and Roche Deny Link to Gene Therapy
FDA; Elevidys; Sarepta Therapeutics; Roche; gene therapy; Duchenne muscular dystrophy; patient death; Brazil; market suspension; safety concerns
Sarepta Halts US Shipments of Duchenne Therapy Elevidys After FDA Pressure
Sarepta Therapeutics; Elevidys; Duchenne muscular dystrophy (DMD); FDA; gene therapy; safety concerns; shipment suspension; patient deaths