Recon: FDA steps ahead of partner nations in approving six cancer drugs under Project Orbis; BIO names John Crowley as new CEO
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
Government, Regulatory & Legal
- 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
