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

• 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)