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Recon: FDA links India-made eye drops to serious adverse events and one death; Gilead’s Trodelvy approved for a third US indication

ReconRecon | 06 February 2023 |  By 

Recon: FDA links India-made eye drops to serious adverse events and one death; Gilead’s Trodelvy approved for a third US indication

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA says India-made eye drop linked to some infections, blindness and one death (Reuters) (Bloomberg) (IndianExpress)
  • Gilead’s Trodelvy Approved for More US Cancer Patients (Bloomberg) (Reuters) (Endpoints)
  • Biogen’s $1.5B Bet for Depressive Disorders Heads to FDA (BioSpace) (Fierce) (Endpoints) (STAT)
  • Bountiful Approvals May Be Ahead As FDA Starts 2023 With Almost 60 Novel Agents Under Review (Pink Sheet)
  • FDA places hold on 4D Molecular’s Fabry gene therapy (Endpoints)
  • Fate of 70+ FDA Guidances Hangs in the Balance as End of Public Emergency Approaches (FDAnews)
  • Eisai reports first U.S. sales of newly approved treatment for Alzheimer’s disease (STAT)
  • Hot Spots In 2023: US FDA Goal Dates Portend Battles In Diseases From RSV To Ulcerative Colitis (Pink Sheet)
  • Legal Expert Weighs In On New US Mandate To Diversify Clinical Trials (MedTech Insight)
  • Patients needing home IV nutrition fear dangerous shortages (Washington Post)
  • Cancer Screenings Plummeted During Covid Surges, Study Says (Bloomberg)
In Focus: International
  • ‘Decentralized Clinical Trials 2.0’ On The Horizon (Pink Sheet)
  • Are Regulators Ready For The Robot Era? ChatGPT Weighs In On EU Regulation (Pink Sheet)
  • India to spend $79.6 million to strengthen drug regulatory system (Reuters)
  • UK Biotechs Still Set On Cashing Out (Scrip)
  • Japan Changes Rules On Drug Names, Study Codes In Sponsors' Trial Sites (Pink Sheet)
Pharma & Biotech
  • Drug companies face COVID cliff in 2023 as sales set to plummet (Reuters)
  • Teva Quits PhRMA As Financial, Policy Challenges Loom For The Brand/Generic Hybrid Giant (Pink Sheet) (Endpoints)
  • Astellas Taps New CEO in Nod to Accelerated Growth (Biospace) (Endpoints)
  • Clinical trial diversity data show mismatch between enrollment and disease prevalence, GSK says (Endpoints) (Fierce)
  • J&J clears PhII for rare blood disorder with drug from $6.5B Momenta buyout (Endpoints)
  • R&D turbulence at Bristol Myers now includes the end of a $650M alliance and the departure of a top research champion (Endpoints)
  • Vaccines slip, Dupixent climbs for Sanofi as it readies multiple launches in 2023 (Fierce)
  • Eisai cutting 91 jobs after out-license deal; Merck touts first-line Keytruda results in endometrial cancer (Endpoints)
  • Canadian plant-based vaccine developer Medicago shutters months after layoffs (Endpoints)
Medtech
  • Siemens’ Varian lands US, EU nods for tool to image tumors in seconds during radiation treatments (Fierce)
  • UK Medtech Strategy Promises To Use Innovation Effectively And Build Resilience (MedTech Insight)
  • Abbott collects European, US clearances for heart ablation catheters (Fierce)
  • The top 10 medtech M&A deals of 2022 (Fierce)
  • Abbott device approval sets up battle with Medtronic, Nevro for diabetic peripheral neuropathy treatment (MedTech Dive)
  • Quest predicts 80% drop in 2023 COVID-19 test revenues (Fierce)
  • Sensor-loaded, $1 smart glove being tested to reduce stillbirths, maternal deaths (MedTech Dive)
  • Bayer taps longtime partner Huma to build online risk prediction tool for heart disease (Fierce)
Government, Regulatory and Legal
  • Boston Scientific found guilty of infringing on drug-eluding stent patent, fined $42M (Fierce)
  • Thyroid Hormone Receptor-Beta Agonists Under USITC Investigation (Bloomberg)
  • U.S. military members suing 3M seek dismissal of subsidiary’s bankruptcy (Reuters)
  • Turkish court hands Novartis and Roche a rare win over their efforts to promote an eye treatment (STAT)
  • Doctor’s opioid prescription conviction tossed after U.S. Supreme Court ruling (Reuters)
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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