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)
- 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)
- 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)
- 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)
- 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)
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