Recon: FDA rejects Astellas’ gastric cancer drug; GSK to buy Aiolos Bio for $1.4B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- New Year’s Predictions From FDA Leadership Past And Present: GLP-1s, Mental Health, Big Data (Pink Sheet)
- Florida’s gambit to import drugs from Canada: ‘a complicated road’ ahead (STAT)
- Sanders, other lawmakers open probe into asthma inhaler makers over pricing, patent maneuvers (STAT)
- #JPM24 quick hits: A 'great year for M&A'; an optimistic Sarepta; Pfizer's CEO + more (Endpoints)
- Astellas hit with CRL for Claudin 18.2 drug due to third-party manufacturing concerns (Endpoints)
- Amazon launches program to connect customers with digital health benefits: #JPM24 (Endpoints)
- Pfizer CEO says it's back to basics after painful 2023 for investors: #JPM24 (Endpoints)
- RTW, Bayer back Cytokinetics-allied Ji Xing Pharmaceuticals with $162M: #JPM24 (Endpoints)
- China approves Alzheimer's treatment Leqembi by Eisai and Biogen (Reuters)
- MedTech Europe Report Shows Strong Market Growth, Unparalleled Innovation and European Trade Surplus (MedTech Insight)
- EMA To Become Observer Of FDA’s Project Orbis Early This Year (Pink Sheet)
- EU Regulators Bemoan Lack Of Trial Applications With Critical Decentralized Elements (Pink Sheet)
- UK ABPI Seeks Feedback On Plans To Tighten & Simplify Code Of Practice (Pink Sheet)
- Patient Input To Help Shape EU Level Joint Clinical Assessments, But Input Quality Will Vary (Pink Sheet)
- Gotham City accounting queries wipe $3.83 billion off Grifols value (Reuters)
- JPM 2024: FogPharma’s new CEO, Mathai Mamman, unveils ‘contrarian’ plan in oncology (STAT)
- GSK to acquire Aiolos Bio in $1.4 billion deal, picking up an experimental asthma drug (STAT) (Reuters)
- Doudna institute hatches plan to ‘cure hundreds of diseases’ left behind by CRISPR revolution (STAT)
- US FDA Says Opioid Database Firm With Purdue Pharma Connections Reported No Conflicts (Pink Sheet)
- Blueprint to pull Gavreto in certain markets, shelve EGFR programs as it focuses on Ayvakit launch (Endpoints)
- Ultragenyx nears $50M Series A for its Alzheimer's gene therapy spinout: #JPM24 (Endpoints)
- BioNTech predicts return to revenue growth in 2025 (Reuters)
- CAR-T Development In Autoimmune Should Continue, FDA’s Marks Says; Malignancy Reports Not ‘Overly Concerning’ (Pink Sheet)
- Mayo Clinic partners with supercomputing startup Cerebras to build custom AI tools (STAT)
- Nvidia says a biological revolution is happening now. But is it? (STAT)
- 5 medtech trends to watch in 2024 (MedTech Dive)
- Medtronic focused on delivering durable revenue and profit growth (MedTech Dive)
- Dexcom plans to launch new CGM this summer for people who don’t take insulin (MedTech Dive)
- Susan Tousi leaves Illumina to become CEO of liquid biopsy firm Delfi (MedTech Dive)
- News We’re Watching: GE And Google Announce AI Initiatives, Medtronic Announces Approvals, And More (MedTech Insight)
- Sen. Maggie Hassan on what Congress must do next to fight the opioid crisis (STAT)
- As Bernie Focuses On Older Drug-Device Combos, Can Innovators Catch Their Breath? (Pink Sheet)
- Anthony Fauci talked Covid in Congress in a nine-hour, closed-door grilling — and that was just day one (STAT)
- HHS’s Xavier Becerra, once an ‘invisible’ secretary, is racing to cement a clearer legacy (STAT)
- The Afghan father aided US soldiers. Now Texas Medicaid won’t pay for his son’s gene therapy (STAT)
- Athersys files for Chapter 11 bankruptcy, sells everything to partner Healios (Endpoints)
- Regulatory Due Diligence Becomes More Critical in a “Hot” Year for Deals in the FDA Space (FDA Law Blog)
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