Recon: FDA signals support for updated COVID vaccines; EMA recommends BioMarin’s hemophilia gene therapy

| 27 June 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA panel to advise on whether — and how — Covid vaccines should be updated (STAT) (NYTimes) (Endpoints) (Fierce)
  • Pfizer/BioNTech say Omicron-based COVID shots improve response vs that variant (Reuters)
  • FDA places partial clinical hold on David Hung biotech after certain cancer patients experience eye inflammation (Endpoints)
  • Astellas’ gene therapy strategy faces fresh setback as FDA puts Pompe disease med on hold (Fierce) (Endpoints)
  • CDC backs Moderna's COVID vaccine for teens, older children (Reuters)
  • US FDA Pursuing Two-Track Approach To Regulatory Convergence For Cell and Gene Therapies (The Pink Sheet)
  • US FDA Would Allow Separation Alternatives In Manufacture Of Low-Risk Beta-Lactams (The Pink Sheet)
  • RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates (The Pink Sheet)
  • White House prepares to fight states over abortion pill (Reuters) (Endpoints) (Bloomberg)
  • Genetic screening results just got harder under new abortion rules (Fierce)
In Focus: International
  • BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval (The Pink Sheet) (Endpoints)
  • EU Bodies Agree Clearer Rules On Joint Procurement Of Vaccines & Treatments (The Pink Sheet)
  • AstraZeneca gets EU backing for targeted breast cancer therapies (Reuters)
  • EMA Gives Oncopeptides’ Multiple Myeloma Drug The Thumbs Up; Keeps US FDA In Loop (The Pink Sheet)
  • Misinformation Prompted Six Court Cases Against EU COVID-19 Vaccine Approvals In 2021 (The Pink Sheet)
  • WHO says monkeypox is not yet a health emergency (Reuters) (Washington Post)
Pharma & Biotech
  • Bruised investors focus on biotechs with drugs closer to market (Reuters)
  • Bristol's Breyanzi wins broader FDA nod, bringing CAR-T showdown with Gilead to earlier lymphoma (Fierce) (Biospace)
  • GSK says its drug for chronic hep B could ‘lead to a functional cure’ — but will it be alone or in combination? (Endpoints) (Fierce)
  • Nuvation’s new solid tumor focus hits snag as FDA slaps hold on a lead asset (Fierce) (Biospace)
  • Amryt Pharma submits a formal dispute resolution to the FDA over rejected skin disease drug (Endpoints)
  • Antios therapy could be a ‘bridge’ in hep B treatment, but first: an FDA hold to resolve (Fierce)
  • Lundbeck, Otsuka announce positive phase III results for Alzheimer's agitation drug (Reuters) (Fierce) (Biospace)
  • Ipsen snags an approved cancer drug in $247M M&A deal as another battered biotech sells cheap (Endpoints)
  • Unable to hit licensing deal terms, Basilea to hand cancer drug rights back to Merck (Fierce)
  • Clover’s COVID booster bolsters antibody levels against omicron (Fierce)
  • AMR Industry Alliance Publishes Manufacturing Standard (The Pink Sheet)
  • Fierce Biotech Layoff Tracker: Vincerx drops third of staff; RedHill reduces commercial team (Fierce)
  • Scientists Zero In on Origins of the Monkeypox Outbreak (NYT)
  • Women are still underrepresented in clinical trials (Washington Post)
  • How Europe’s Nomenclature System Works And Offers New Insights (MedTech Insight)
  • MHRA Offers Medtechs Extra Transition Time For UK Regulatory System Compliance (MedTech Insight)
  • NICE: Real-World Evidence Revolution Will Drive UK’s Health Care Innovation (MedTech Insight)
  • BD recalls emergency vascular access devices over risk of delayed care (MedTech Dive)
  • Novel VR Treatment For Mental Illness Gets FDA Breakthrough (MedTech Insight)
  • Amid Medtronic sale, Acutus nabs another FDA clearance for lift-heart access portfolio (Fierce)
  • Paige Secures Eighth CE Mark For Cancer Identification AI (MedTech Insight)
  • Medtech M&A falls 85% but activity could rebound in second half: report (MedTech Dive)
Government, Regulatory & Legal
  • Bristol Myers must face $6.4 bln lawsuit over delayed cancer drug (Reuters) (Fierce)
  • Supreme Court Rules for Doctors on ‘Pill Mill’ Prosecution Proof (Bloomberg)
  • A ‘colossal financial fraud’: Gilead to get $33 million from a clinic for exploiting its HIV patient assistance program (STAT)
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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