Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Pfizer COVID vaccines safe and effective for small children, FDA staff say (Reuters) (NYTimes)
- U.S. FDA staff says Moderna COVID vaccine effective and safe for children (Reuters) (Politico)
- FDA requires disclosure of suicide risk for anti-baldness drug (Reuters)
- Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms (Reuters) (STAT)
- U.S. Supreme Court rebuffs opioid maker Insys founder's conviction appeal (Reuters)
- EU agency sees risk of COVID deaths rising as Omicron subvariants spread (Reuters)
- Sanofi says next-gen COVID booster shot has potential against main variants (Reuters)
- Valneva shares plunge as European COVID vaccine deal flounders (Reuters)
- Amylyx gets first approval for ALS drug from Canada (Reuters) (STAT)
- GSK says RSV vaccine for older adults ‘offers exceptional protection’ (STAT)
- Indiana manufacturer to construct facility for radioligand production (Endpoints)
- SPAC merger called off as company connected to ex-Purdue CEO decides to remain private (Endpoints)
- With pan-RAF drug from Takeda, Day One unveils its first pediatric brain cancer data. And the market loves it (Endpoints)
- On bluebird's heels, CRISPR Therapeutics and Vertex take the air with interim CRISPR blood cell therapy data (Endpoints) (STAT)
- Ivermectin Has Little Effect on Recovery Time From Covid, Study Finds (NYTimes)
- Novartis may still be grappling with Kymriah sales, but historic CAR-T promise still shines through 5-year data (Endpoints)
- Homology cleared to resume gene therapy trial for rare metabolic disease after FDA lifts hold (Endpoints)
- Looking to expand nasal spray indication, Optinose secures second PhIII win (Endpoints)
- A biotech upstart just scored $103M from Pfizer et al to fuel its pursuit of a new (to you) I/O pathway (Endpoints)
- US FDA’s ‘Mature’ Approach To Quality: ‘Encourage More, Punish Less’ (Pink Sheet)
- Lensar eyes launch of AR-assisted cataract surgery system after FDA clearance (Fierce)
- Ekso Bionics nabs FDA exoskeleton clearance for multiple sclerosis rehabilitation (Fierce)
- FDA clears digital tool to help diagnose autism in children as young as 16 months (Fierce)
- ADA: Beta Bionics' automated insulin pump slashes glucose levels, diabetes distress in Type 1 patients (Fierce)
- Dräger’s breathing system filter recall gets Class I label from FDA after ventilation obstruction (MedtechDive)
- ResMed warns supply constraints may last 18 months after Philips completes recall of sleep-apnea devices (MedtechDive)
- UnitedHealth links CGM use in people with Type 2 diabetes to improved blood sugar control (MedtechDive)
- Q&A: Meet DHCOE Acting Chief Brendan O’Leary, FDA’s New Digital Health Guru (MedtechInsight)
- Stock Trader Pleads Guilty to Defrauding Investors in Medical Technology Company (DoJ)
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