Recon: Novo to finalize its $16.5B Catalent acquisition; FDA approves Neurocrine’s CAH treatment

• Novo Holdings is set to close its $16.5 billion acquisition of Catalent after FTC declines to challenge the deal (STAT)
• Outgoing CDC director girds against an overhaul, and tries to calm staff nerves (STAT)
• I used to do health insurance company PR. Here’s what I think the backlash is missing (STAT)
• Three major health care policy issues to watch in 2025 (STAT)
• Weight-loss drugs draw Americans back to the doctor (Reuters)
• Neurocrine's Crenessity ends 70-year drought with FDA nod for rare genetic disease (Fierce Pharma) (Reuters)
• NDA Yo-Yo: FDA Receives Second-Lowest Submission Count In October After September Bolus (Pink Sheet)
• Consulting firm McKinsey to pay $650 million to resolve US opioid charges (Reuters)

• South African regulator decides Vertex provides sufficient access to CF drugs, angering activists (STAT)
• Novo Nordisk to spend $1.2B for new rare disease drug factory in Denmark (Endpoints)
• Indonesia detects African swine fever in most of its provinces (Reuters)
• What Will It Take For Korea To Become A Trial Hot Spot? (Pink Sheet)
• Don't Let Drug Regulators Handle Medical Devices: EU Needs Dedicated Agency’' (MedTech Insight)
• Have Your Say: European Commission’s Targeted Evaluation Consultation Open (MedTech Insight)
• Nvidia Acquires Vingroup's VinBrain AI Firm (MedTech Insight)

• Viridian confirms benefit of drug for thyroid eye disease (STAT)
• Broken promises, lax scrutiny: Inside Massachusetts’s failure to regulate Steward Health (STAT)
• (Your name here) gene therapy: new fund-raising gambit for family with rare disease (STAT)
• My oral cancer shows the deep connections between chronic and infectious disease (STAT)
• GLP-1 drugs spark disagreements in Trump’s circle (STAT)
• Bristol Myers drops cell therapy pacts with Immatics, Century as part of portfolio review (Endpoints)
• Roche terminates a Phase 3 Spark gene therapy in hemophilia A (Endpoints)
• Biohaven’s protein degrader cuts antibodies by 60% (Endpoints)
• PureTech declares mid-stage trial win for pulmonary fibrosis drug (Endpoints)
• Candid inks three T cell engager deals; PepGen trial put on hold (Endpoints)
• Novo's Ozempic faces scrutiny over potential link to rare eye disease (Reuters)
• AstraZeneca Says Andexxa Will Not Convert To Full Approval, Quietly Reveals Complete Response (Pink Sheet)
• FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What CMC Questions Did They Answer? (Part 2) (FDA Law Blog)
• Checkpoint Therapeutics takes on Merck's mighty Keytruda with FDA approval for Unloxcyt in skin cancer (Fierce Pharma)
• FDA blesses atopic dermatitis label expansions for Organon's Vtama, Galderma's Nemluvio (Fierce Pharma)

• FDA authorizes many AI devices for use in kids. Are they validated in a pediatric population? (STAT)
• Inside Isomorphic Labs: Demis Hassabis’ lab-free vision for biotech’s AI future (Endpoints)
• How AI can help bring better care to Medicaid patients (STAT)
• CDRH cyber chief on compliance with new rules, ongoing security threats (MedTech Dive)
• Augmedics names Paul Ziegler as CEO (MedTech Dive)
• FDA issues first early alert with Fresenius Kabi infusion pump recall (MedTech Dive)
• Endoquest robotic system gets FDA OK to launch clinical trial (MedTech Dive)

• Feds threaten Sanofi with sanctions over plan to change payment terms for a federal drug discount program (STAT)
• CMS Tells MA Plans Not To Exclude Biogen’s Qalsody Because Of Accelerated Approval (Pink Sheet)