Recon: FDA approves Akebia’s anemia drug Vafseo; US senators told WuXi AppTec shared companies’ IP with Chinese government
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- U.S. FDA approves Akebia's anemia drug (Reuters)
- Roche wins FDA approval for first molecular malaria blood donor screening test (MedTech Dive)
- How GLP-1’s moved from research labs to national TV (STAT)
- Oprah kicked off a national conversation on obesity and GLP-1 drugs. Let’s have it (STAT)
- Ozempic-like drugs linked to low, but increased risk of post-endoscopy pneumonia, study finds (STAT)
- Bernie Sanders implores Novo to cut list prices of Ozempic, Wegovy (Endpoints)
- Who can sue the FDA? Answering Justice Alito’s question from the mifepristone arguments (STAT)
- China's WuXi AppTec shared US client's data with Beijing, US intelligence officials told senators (Reuters)
- WuXi AppTec, WuXi Biologics continue to build out US presence despite political tensions (Endpoints)
- U.K. becomes the first country to release detailed data on sponsors that fail to register clinical trials (STAT)
- WHO Launches Twin-Track Procedure To Speed Access To Health Products (Pink Sheet)
- England’s NICE Says No To Santhera’s DMD Drug Agamree Due To ‘Unreliable Modeling’ (Pink Sheet)
- EU Regulatory Assessors Get AI Boost In Reaching Scientific Decisions (Pink Sheet)
- Sanofi's distribution deals; AstraZeneca to supply US and China independently; Merck KGaA expands in China (Endpoints)
- A contrarian view on Viking Therapeutics, biotech’s hottest obesity stock (STAT)
- Why the world’s most expensive drug might not be all that overpriced (STAT)
- Gilead pays $43M to license Xilio’s IL-12 program that could turn ‘cold’ tumors ‘hot’ (Endpoints)
- Aldeyra to run another trial for its dry eye disease drug as part of resubmission plans (Endpoints)
- Exclusive: ADC startup Mythic recruits Jazz exec to lead company; Dyne’s CEO shuffle (Endpoints)
- Bayer to cut 90 workers; Avalo's up to $185M private placement (Endpoints)
- Pelago raises $58M to expand online substance use treatment (Endpoints)
- Of the few preclinical IPOs, Metagenomi keeps details about IND plans close (Endpoints)
- Exclusive: Intellihealth, a startup working with the state of Connecticut to provide weight loss care, raises $24M (Endpoints)
- 'Don't Compromise The Pharma Innovation System,' Says Outgoing IFPMA Head Thomas Cueni (Pink Sheet)
- Bristol Myers to conduct layoffs at Mirati facility in California (Endpoints)
- Hologic expects facility closures in diagnostics division (MedTech Dive)
- Boston Scientific’s $3.7B Axonics buy tops list of medtech M&A in 2024 (MedTech Dive)
- J&J in talks to buy Shockwave Medical: WSJ (MedTech Dive)
- FDA hits Renovo with warning letter over reprocessed medical devices (MedTech Dive)
- Neuronetics wins FDA clearance for device to treat adolescents with depression (MedTech Dive)
- J&J files for FDA approval of Varipulse pulsed field ablation platform (MedTech Dive)
- Abbott receives CE mark for 6-year insertable cardiac monitor (MedTech Dive)
- UnitedHealth offers over $3.3 bln in loans to providers hit by attack on unit (Reuters)
- Covid’s scientific silver lining: A chance to watch the human immune system respond in real time (STAT)
- J&J can contest evidence linking its talc to cancer, US judge rules (Reuters)
- Merck’s Winrevair Well Positioned To Benefit From Medicare Part D Redesign (Pink Sheet)
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