Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

ReconRecon
| 13 June 2022 | By Michael Mezher 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • Stock Trader Pleads Guilty to Defrauding Investors in Medical Technology Company (DoJ)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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