Recon: FDA warns Evusheld ineffective against emerging Omicron subvariant; Production woes prompt Takeda to discontinue hypoparathyroidism drug
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Another one bites the dust? FDA warns that emerging Omicron subvariant could make Evusheld obsolete (Endpoints) (Fierce)
- Another warning letter for Lupin as FDA identifies deficiencies at India-based site (Endpoints)
- Califf: FDA Launches External Review Into FDA’s Handling of Approved Opioids (FDAnews)
- US FDA Still Hasn’t Decided Who Will Be Final Arbiter On Approval Status For Covis’ Makena (Pink Sheet)
- In-Person US FDA Meetings Returning? Agency Will Support Those Events At HQ (Pink Sheet)
- Capacity to spare: US has manufacturing firepower to crank out more essential medicines, researchers say (Fierce)
- Vir Biotech gets U.S. funding for flu-prevention antibody (Reuters) (Endpoints)
- Doctors urge U.S. FDA to add miscarriage management to abortion pill label (Reuters)
- Medicare Gives Biosimilars Boost, First Step in Drug Pricing Law (Bloomberg)
- EU Drug Supply In Jeopardy Without Energy Support, Warns Industry Group (Pink Sheet)
- EMA Raises Industry Fees For EU Pharmacovigilance Services (Pink Sheet)
- UK Avoids 'Cliff Edge' By Extending EU Drug Approval Reliance Procedure (Pink Sheet)
- €5m Initiative To Help EU Member States Cooperate On Trial Safety Assessments (Pink Sheet)
- Takeda to pull key hypoparathyroidism drug from the market entirely by end of 2024 after years of manufacturing woes (Endpoints) (Biopharma Dive)
- Bristol Myers inks protein degrader deal via Celgene team's link to seed-stage biotech (Endpoints) (Biospace) (Fierce)
- Sanofi spies miRecule therapy, wagering $400M in biobucks to go after muscular dystrophy with RNA (Fierce) (Biospace)
- Pfizer, Clovis Make Inroads Against Tough to Treat Prostate Cancer (Biospace) (Fierce)
- Mission in-Komplete: KalVista axes angioedema program over raised enzyme levels (Fierce) (Reuters) (Biospace)
- Can a smartphone app detect Covid? Pfizer throws down $116M to find out (Endpoints)
- After 12 months of digging, Pfizer opts for one of two Voyager capsids for gene therapy (Endpoints) (Fierce)
- Pfizer Needs to Prove That It’s Ready to Move On From Covid-19 (Bloomberg)
- AstraZeneca’s LogicBio Buyout Will Give Other Troubled Gene Therapy Companies Hope (Scrip)
- Clene Sees Path Forward For ALS Candidate Despite Late-Stage Trial Failure (Scrip)
- After Adamis’ COVID-19 flop, company weights future and warns layoffs could be in the cards (Fierce)
- At Long Last, Can Malaria Be Eradicated? (NYT)
- CAR-T therapy doesn’t work in all cancer cases. Scientists are starting to figure out why (STAT)
- European Commission Reshuffle Sees New Innovation Focus For Devices (Medtech Insight)
- LivaNova recall of open-heart-surgery blood pump designated as Class I event by FDA (MedTech Dive) (MedTech Insight)
- Small Business Research Grants Reauthorized Under The Wire (MedTech Insight)
- Cardio Catch-Up: Medtronic, Recor, Pulnovo Report Progress On Denervation To Treat Hypertension (MedTech Insight)
- Northwestern spinout look to adapt COVID platform for monkeypox tests (Fierce)
- In ‘skinny’ label fight between Teva and GSK, Supreme Court asks Biden admin for help (Fierce)
- US Supreme Court Preview: ‘Skinny’ Labels, FTC, And FCA – But No Tecfidera As Biogen Loses Bid (Pink Sheet)
- California Court rules in favor of Plexxikon in patent dispute with Novartis (Pharma Letter)
- Roche, LifeScan Proceed in Diabetes Test Strip Fraud Suits (Bloomberg)
- Elizabeth Holmes Sentencing Reset as Judge Weighs New Trial Bid (Bloomberg)
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