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