Recon: Lilly to acquire DICE in $2.4B deal; FDA places hold on Gilead BCMA CAR-T trial

• Agepha Pharma gets ancient gout remedy colchicine across FDA finish line for heart disease (Fierce)
• FDA Pilots Program for Oncology Drug Products, Diagnostic Tests (Bloomberg)
• US FDA extends review for GSK-owned Sierra's blood cancer therapy (Reuters)
• FDA puts Gilead’s $225M BCMA CAR-T on hold over patient death, delaying potential rival to J&J, BMS (Fierce) (BioSpace)
• F2G gets rejected by the FDA, which wants more data before it will approve antifungal drug, company says (Endpoints) (Fierce)
• ‘Falling through the cracks’: Why ADHD is under-diagnosed among Asian Americans (STAT)
• Testosterone supplementation not linked to heart attacks in study, reversing earlier finding (STAT)

• Indian drugmaker denies syrup exported to Liberia is toxic (Reuters)
• Exclusive: WHO says toxic syrup risk 'ongoing', more countries hit (Reuters)
• EU Pilots Real-Time Generation Of Electronic Product Information By Drug Companies (Pink Sheet)
• Two Hemophilia Treatments Among 15 New EU Filings (Pink Sheet)
• French President Calls For Repatriation Of Essential Drug Production (Pink Sheet)
• Vaccines & Oligonucleotides Flagged As Key UK Manufacturing Opportunities (Pink Sheet)
• Another Step Forward for African Medicines Agency (Pink Sheet)
• Analysis: New rules set to shake up China's shrinking infant formula market (Reuters)

• Merck closes $10.8B deal with Prometheus (Endpoints) (BioSpace)
• Eli Lilly to acquire DICE Therapeutics in $2.4 billion deal (STAT) (Bloomberg) (Endpoints)
• Game on, AbbVie. Roche’s Columvi nabs FDA nod as 2^nd bispecific for large B-cell lymphoma (Fierce) (Pink Sheet) (Endpoints)
• Novo Nordisk lowers European launching pace of Wegovy in face of huge demand (MedWatch) (Reuters)
• Report: Mounjaro will overtake Novo Nordisk’s diabetes and obesity drug in short time (MedWatch)
• Former British Prime Minister Boris Johnson’s first big job after quitting Parliament: Chewing the fat on Ozempic (Fierce)
• ChatGPT Gaining Foothold in Drug Development, Clinical Trials (Bloomberg)
• Keytruda combination hits primary endpoint in a rare form of gastric cancer (Endpoints)
• Bavarian Nordic bites back in chikungunya vaccine race, hitting phase 3 goal to stay on Valneva’s heels (Fierce)
• Denali claims a neurofilament victory in Hunter syndrome, two years after letting down Wall Street (Endpoints)
• Frazier and Alamar Biosciences create immune and cancer biotech Attovia with $60M in funding (Endpoints)
• Fierce Biotech Layoff Tracker 2023: More layoffs at Molecular; Surface shrinks by half (Fierce) (Endpoints)
• Thermo Fisher Cuts 88 Jobs in San Diego in Fourth Round of Layoffs This Year (BioSpace)
• Merck's Keytruda fails to meet one main goal in gastric cancer trial (Reuters)

• Musk expects brain chip start-up Neuralink to implant 'first case' this year (Reuters)
• Notified Bodies Must Be Involved In EU Joint HTA Discussions, Urges BSI Clinical Compliance Lead (MedTech Insight)
• COCIR Report Maps Digital Health Market Access Routes In 6 European Countries (MedTech Insight)
• UK Medtech's Gateway to Regulatory Opportunity is Open – But for How Long? (MedTech Insight)
• The Frontier Of Digital Therapeutics Regulations (MedTech Insight)
• Surmodics secures FDA nod for PAD balloon, earning payment from Abbott (MedTech Dive)
• Siemens Healthineers lays off 67 New Jersey workers amid diagnostic cuts (Fierce) (MedTech Dive)
• BD plans $540M sale of surgical instrumentation platform to Steris (MedTech Dive)

• J&J, Depuy Must Face Sales Representative’s Retaliation Claim (Bloomberg)
• Will US Pharma See Lawsuits over COVID Vaccine Side Effects? (BioSpace)
• US FDA Rejects Melinta Effort To Go Beyond Court Order In FedEx-Driven ANDA Dispute (Pink Sheet)
• Novo Nordisk sues spas, wellness clinics for selling counterfeit weight-loss drugs (Reuters)
• BMS sues US government over drug price negotiations (MedWatch)
• For groups fighting U.S. opioid crisis, settlement money can be hard to come by (Reuters)