Recon: FDA steps ahead of partner nations in approving six cancer drugs under Project Orbis; BIO names John Crowley as new CEO

• Project Orbis 2023: FDA Approves Six New Cancer Drugs, But Partner Nations Lag Behind (Pink Sheet)
• FDA Puts Clinical Hold on Roche BTK Inhibitor Multiple Sclerosis Program (BioSpace)
• CRISPR Reorganizes CAR-T Pipeline Ahead of FDA’s Landmark Decision (BioSpace)
• BIO selects rare disease advocate, biotech executive John Crowley as new CEO (STAT)
• Cancer drug shortages won’t get better under Biden’s latest plan (STAT)

• Controversial EU Study On Pharma Innovation & Access Sees The Light Of Day (Pink Sheet)
• Stigma, regulatory barriers delay mpox response in country that needs it most (Reuters)
• Abbisko signs $70M upfront deal with Merck KGaA for PhIII cancer drug (Endpoints)
• India's Apollo Hospitals' operator rejects allegations of illegal kidney transplants (Reuters)
• US regulators inspect Dr Reddy's, other Indian pharma majors (Reuters)

• Johnson & Johnson forecasts as much as 6% sales growth in 2024 (Reuters)
• Carmot’s chance of beating the odds in the biotech market just ended (STAT)
• New CAR-T company, Brainchild Bio, will focus first on brain tumors in children (STAT)
• J&J to emphasize cancer drugs and stop much of its vaccine research (STAT)
• Roche’s bid to build a better Piqray yields phase 3 breast cancer win, opening doors to regulators  (Fierce)
• Drug Companies Explore Making Most Lucrative Drugs in Space (Bloomberg)
• Scoop: Infectious disease biotech eyes $25M Series A to advance antibody for chronic lung infection (Endpoints)
• AbbVie’s new AI deal; Roche's PhIII win in breast cancer; SpringWorks to raise $275M (Endpoints)
• Bausch Health’s Salix initiates first awareness day for opioid-induced constipation (Endpoints)
• Boehringer looks 'beyond stable' to display the everyday realities of life with schizophrenia (Endpoints)
• Travere plans to lay off 20% of workforce as it focuses on full approval for kidney disease drug (Endpoints)
• A CAR-T therapy invented at Seattle Children’s was never approved for kids. Now the hospital is launching its own pediatric CAR-T startup (Endpoints)

• EU Regulatory Roundup, November 2023: Notified Body Advances But Sector Still Demands System Rethink (MedTech Insight)
• Baxter sends another safety notice about syringe infusion pump errors (MedTech Dive)
• ChatGPT doesn’t know much about drugs, Hims & Hers enters weight-loss market (STAT)
• Intuitive’s venture capital arm launches second investment fund (MedTech Dive)

• Laboratory trade group, providers oppose FDA’s lab developed test proposal (MedTech Dive)
• Device Maker B. Braun Must Face Product Warning, Defect Lawsuit (Bloomberg)
• J&J Pushing to Settle Baby Powder Cases Linked to Asbestos (Bloomberg)
• CVS Health joins in on a new way for pharmacies to get paid for prescription drugs (Endpoints)