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June 13, 2023
by Joanne S. Eglovitch

Recon: European experts unconvinced by Eisai, Biogen Alzheimer’s drug; FDA seeking new methotrexate suppliers amid cancer drug shortages

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • FDA OKs Over-the-Counter Gel for Erectile Dysfunction (MedPage Today) (FDAnews) (Medical Device Network)
  • First Drug Approved for Kids' Functional Constipation (MedPage Today)
  • US seeks new suppliers of highly used cancer drug methotrexate in short supply (Reuters)
  • FDA lays out what to expect at adcomm's selection of strains for Covid-19 vaccine campaign this fall (Endpoints)
  • FDA, Congress and the White House Struggle to Reduce Drug Shortages (FDAnews)
  • Pending FDA's OK, Teva and Alvotech can bring their Stelara biosimilar to US market by 2025 (Endpoints)
  • How Much Delay In Alzheimer’s Disease Progression Is Clinically Meaningful? (Pink Sheet)
  • The FDA Commissioner Gets Political (WSJ)
  • Obamacare Mandate for Preventive Care Is Restored, for Now (NYT) (Bloomberg) (Reuters)
  • Sanders Blasts High Drug Costs When NIH Research Helped (Bloomberg)
  • Lower Dementia Risk May Be Linked With Shingles Vaccine (MedPage Today)
In Focus: International
  • European Alzheimer's experts unconvinced by new Eisai, Biogen drug (Reuters)
  • Britain's COVID-19 inquiry hears government was under-prepared (Reuters)
  • Macron unveils plans to relocate production of key drugs to France (Reuters)
  • Italy to pass 'right to be forgotten' law for cancer survivors – PM (Reuters)
  • Childhood vaccine rates show signs of recovery after pandemic backslide – Gavi (Reuters)
Pharma & Biotech
  • GSK’s Walmsley On US v. EU COVID-Flu Combos, RSV Branding, And Investing In Infectious Disease (Pink Sheet)
  • Once promising cancer therapy startup Oncorus admits defeat after laying off most of its staff (Endpoints) (Fierce)
  • Biotech executive nominated to Biogen board is mother of director’s child, records show (STAT) (Endpoints)
  • Seagen Touts Adcetris Early-Stage Lymphoma Data with 93% Complete Remission (BioSpace) (Endpoints)
  • AstraZeneca turns to cows to cut U.S. carbon footprint (Reuters)
  • Okamura acted on the company’s mantra to be ‘aggressive’ (Fierce)
  • Booted by Big Pharma, Turnstone asks public investors to fund early-phase cell therapy trials (Fierce)
  • Moving past regulatory obstacles, Protagonist Therapeutics looks to pivotal trial for its rare blood disorder therapy (STAT)
  • Salvation of ‘death warrant’? Erytech’s war with activist investor rumbles on as merger vote nears (Fierce)
  • Catalent Finally Reports Earnings: Despite Losses, Revenue Beat Projections (BioSpace) (Fierce)
Medtech
  • EU AI Act Legal Deep-Dive Part 2: Balancing Medtech Innovation With Safety (MedTech Insight)
  • Medtronic warns cardioversion can fry some Vanta neurostimulators (Fierce)
  • Abbott names Philip Boudreau as CFO (MedTech Dive)
  • Huma Granted Class II Clearance By FDA For Its Disease-Agnostic Platform (MedTech Insight) (MedTech Dive)
  • Breast Ultrasound Recs May Not Be Targeting the Right Women (MedPage Today)
  • The Afterlife Of Pear Therapeutics: Korean DTx Maker Discusses Vision For Salvaged Migraine Assets (MedTech Insight)
  • Minute Insight: Merit Adds Dialysis and Biopsy Products For $132.5m (MedTech Insight)
  • Hospitals are testing AI to communicate with patients. They still don’t know how to talk to them about it (STAT)
Government, Regulatory & Legal
  • Supreme Court’s False Claims Ruling Leaves Plenty to Litigate (Bloomberg)
  • Jury in Bard mesh trial won't hear about 2011 factory fire, judge rules (Reuters)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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