Recon: FDA authorizes Apple’s AirPods Pro hearing aid software; Moderna slashes R&D spending by $1.1B but praises research advances
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- FDA authorizes first OTC hearing aid software to be used in Apple's AirPods Pro (Reuters) (STAT)
- A rare disease program, portrayed as both lifeline and pharma handout, is set to expire (STAT)
- Gilead’s twice-yearly antiviral protects against HIV infection in second large trial (STAT)
- Key Senate Republican throws cold water on Affordable Care Act repeal, site-neutral payment policy (STAT)
- Moderna touts research progress as it cuts R&D spending by $1.1 billion (STAT) (Reuters)
- How to keep the BIOSECURE Act from hobbling U.S. biotech and pharma (STAT)
- J&J's proposed talc settlement sparks lawsuit between plaintiffs' firms (Reuters)
- Weight-loss market to see 16 new drugs by 2029, report estimates (Reuters)
- Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency (Pink Sheet)
- Roche shares knocked by concern over side effects in obesity pill trial (Reuters)
- Australian RNA manufacturer launches; Forge Biologics’ CEO steps down (Endpoints)
- Debiopharm, ITM ink €300M licensing deal for cancer treatment (Endpoints)
- US FDA sends warning letters to two Chinese firms for violating lab practices (Reuters)
- India And Pakistan Boost Transparency In Industry-Doctor Interactions (Pink Sheet)
- Africa CDC confident it can raise $600 million for mpox response (Reuters)
- Bavarian Nordic sees potential to ramp up mpox vaccine capacity (Reuters)
- Can iTeos and GSK solve TIGIT’s troubles? (STAT)
- Sofinnova’s Jim Healy on ‘more rational market’ as four biotech startups near their IPOs (Endpoints)
- Fulcrum's Phase 3 for old GSK drug fails, stock sinks (Endpoints)
- GSK’s mRNA flu shot is heading to Phase 3; Summit’s $235M offering (Endpoints)
- Charles River to lay off 3% of staffers as it streamlines spending (Endpoints)
- A new startup wants to fight cancer with 'off-the-shelf' gene therapy, securing $26M seed round (Endpoints)
- Roche to launch new CGM in Europe in ‘coming weeks’ (MedTech Dive)
- SS Innovations expects US OK for surgical robot in 2025 (MedTech Dive)
- FDA to investigate presence of metals in tampons (MedTech Dive)
- J&J leads $50M financing for imaging company Spectrawave (MedTech Dive)
- Dexcom, Abbott OTC glucose sensors add to busy year for diabetes tech (MedTech Dive)
- 5 takeaways from Congress’ hearing on overhauling organ transplant system (STAT)
- Update on the DEA's efforts to reschedule cannabis: what you need to know (Reuters)
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