Recon: EU approves Pfizer’s acquisition of Seagen for $43B; Partisan sparks fly at NIH director confirmation hearing

• Intellia Gets Phase III Greenlight from FDA for Gene Editing Therapy (BioSpace)
• UCB Wins FDA Approval for Plaque Psoriasis Therapy After Regulatory Setbacks (BioSpace)
• Pfizer Prices Covid Drug Paxlovid at $1,400 for a Five-Day Course (The Wall Street Journal)
• NIH confirmation hearing highlights just how divisive the agency’s portfolio has become (STAT)
• US FDA Struggling With Long-Term Follow-Up Requirements For Gene Therapies (Pink Sheet)
• Amazon will start testing drones that will drop prescriptions on your doorstep, literally (Associated Press)
• FDA Deputy Commissioner for Human Foods Commits to Fulfilling Vision of Proposed Program (FDA)
• Corporate America weighs risks of the Ozempic effect (Reuters)
• J&J builds out global manufacturing capacity for CAR-T Carvykti (Endpoints)

• Pfizer wins unconditional EU antitrust okay for $43 bln Seagen buy (Reuters)
• EMA looks into falsified Ozempic with German and Austrian origins (Endpoints)
• EU HTA Regulation: Tight Deadlines & The Future Of Collaboration (Pink Sheet)
• WHO Calls For Countries To Regulate Use Of AI In Medicine (Pink Sheet)
• Pharmaceuticals giant Takeda settles with Revenue Commissioners for €130m (The Irish Times)
• Merck KGaA says MS drug has blockbuster potential; key data expected in December (Reuters)
• Japan agreed to buy additional COVID-19 vaccine doses from Pfizer and Moderna (Reuters)
• Royalty Pharma to pay $1 bln for Roche's SMA drug royalties (Reuters)
• Roche makes four pipeline changes on back of trial failures, but sees path ahead for three therapies (Endpoints)
• Scoop: Eli Lilly agrees to acquire another European ADC biotech (Endpoints)

• AstraZeneca shares fall as lung cancer drug trial data abstract disappoints (Reuters)
• Zuckerberg and Chan announce a New York biohub to build disease-fighting cellular machines (STAT)
• Biotech power broker John Maraganore offers advice to the next crop of entrepreneurs (STAT)
• How rising stars in science and medicine think about mentorship and bouncing back from rejection (STAT)
• Bristol Myers' injectable form of Opdivo meets main goal in kidney cancer trial (Reuters)
• Nestle begins work on 'companion products' for weight loss drugs (Reuters)
• Risky biotech M&A therapy will heal more fractures (Reuters)
• Beam cuts 20% of staff, looks to partner on base-edited CAR-T one month after dosing first patient (Endpoints)
• Emergent recruits NFL Hall of Famer for Narcan opioid overdose campaign (Endpoints)

• After years of hype, the first AI-designed drugs fall short in the clinic (Endpoints)
• Biotech Industry Advised To Prepare For Incoming EU AI Regulation (MedTech Insight)
• UK Medtech Takes More Steps To Assert Itself In The Global Market (MedTech Insight)
• Edwards Lifesciences claims European approval for transcatheter tricuspid valve implant (Fierce)
• What if there’s no market for a CRISPR cure? (STAT)
• Non-Invasive Remote Patient Monitoring Guidance Updated For Post-Pandemic World
• (MedTech Insight)
• Abbott raises outlook amid strong Q3, sees momentum into 2024 (MedTech Dive)
• Cybersecurity incident prompts Henry Schein to take systems offline, disrupting operations (MedTech Dive)
• Siemens Healthineers partners to improve tuberculosis screening using AI (MedTech Dive)
• BD recycles 40,000 pounds of medical waste in circular economy pilot project (MedTech Dive)

• Recent ruling doesn't bolster J&J's defamation case, scientist says (Reuters)
• Woman to plead guilty for conspiracy that defrauded Lilly (Inside Indiana Business)
• Senate Finance targets Medicare Advantage brokers (STAT)
• When Medicare paid doctors differently, fewer patients had heart problems (STAT)
• Walgreens to settle Rite Aid investors' merger claims for $192 million (Reuters)
• Illinois man accused of insider trading after making nearly $100K on Pfizer-Array buyout (Endpoints)
• We Will Clear You: DEA’s National Prescription Drug Take Back Day (FDA Law Blog)