Recon: Moderna announces bivalent booster more effective than current vaccine; Regeneron acquires Checkmate for $250M

• Moderna says dual variant booster with Beta more effective vs Omicron than current shot (Reuters) (Fierce) (STAT) (Biospace)
• Developing non-opioid pain drugs: Companies question if FDA is raising the bar (Endpoints)
• Axsome moves ‘closer to judgement day’ for stalled depression therapy (Fierce) (Endpoints)
• FDA issues warning to companies selling unapproved skin lightening products (Reuters)
• Kite’s Maryland CAR T-cell therapy site gets FDA go-ahead (BioPharma Reporter)
• Brewing Alzheimer’s Drug Plan Fights Rest in Patients’ Hands (Bloomberg)
• New CDC team: A weather service to forecast what’s next in pandemic (Washington Post)
• CMS Announces Two Public Meetings To Discuss Clinical Diagnostic Lab Tests (MedTech Insight)
• Industry Urged To Share Potential Regulatory Challenges To Decentralized Manufacturing (The Pink Sheet)
• Nation’s top cancer hospitals slap hefty markups on drugs, study says (STAT)

• Analysis: Demand for Pfizer's COVID pills lags around the world (Reuters)
• Ukrainian Firm To Receive mRNA Tech Transfer From WHO Hub (The Pink Sheet)
• Malaysia Announces Voluntary Pharmacovigilance Inspections From Jan 2023 (The Pink Sheet)

• J&J suspends sales forecast for COVID vaccine, cuts profit view (Reuters)
• Poland declines to take or pay for more COVID-19 vaccines for now (Reuters)
• China’s Home-Grown Oral COVID Antiviral Eyes Wider Population (Scrip)
• Fourth COVID-19 vaccine shot possible for some in Mexico, official says (Reuters)

• Regeneron sees skin cancer potential beyond PD-1s with $250M Checkmate acquisition (Fierce) (STAT)
• In nation’s biotech hub, layoffs, closures, and mergers expected as part of an industry ‘correction’ (STAT)
• Fierce Biotech Layoff Tracker: Layoffs hit small biotechs Finch, Imara (Fierce)
• Enhertu nabs priority review for NSCLC as AstraZeneca and Daiichi Sankyo continue charting a blockbuster course (Endpoints)
• OrbiMed-backed biotech looks to challenge Vertex in cystic fibrosis by 'drugging the undruggable' (Endpoints)
• Korea’s GC inks deal to secure US cell and gene therapy focused CDMO (BioPharma Reporter)
• Acadia's prized pain drug from $52M buyout flops its first test (Endpoints)
• AstraZeneca's Alexion to take new R&D space in biotech tower in New Haven (Endpoints)
• The 20(+1) under 40: Your guide to the next generation of biotech leaders (Endpoints)
• Scientists Question Data Behind an Experimental Alzheimer’s Drug (NYT)
• Getting Into Drug Trials Is Easier If You’re White (Bloomberg)
• Animal rights group urges USDA to probe research facilities for failing to inspect monkey shipments (STAT)

• AstraZeneca strengthens ties with Chinese cancer diagnostic developer AmoyDx (Fierce)
• Axionics kicks off U.S. launch of recharge-free sacral neuromodulation implant (Fierce)
• Another SPAC deal cracks as spine implant maker Accelus calls off Nasdaq plans (Fierce)
• Investigating FDA’s breakthrough devices, big data ethics, & AI for colon cancer (STAT)
• Bionic limbs lift Gaza amputees' self-esteem (Reuters)

• J&J Pays $25 Million to End Antitrust Case Over Autoimmune Drug (Bloomberg)
• Vifor Sued for Damages on Process for Making Injectafer Drug (Bloomberg)
• New Court Takes The Wheel In NY’s Vast Opioid Litigation (Law360)
• Crescendo Bioscience, Myriad Settle Blood Test Kickback Claims (Bloomberg)