Recon: FDA warns Evusheld ineffective against emerging Omicron subvariant; Production woes prompt Takeda to discontinue hypoparathyroidism drug

• 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)