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

ReconRecon | 04 October 2022 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
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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