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)
- ‘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)
- 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)
- 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)
- 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)
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