Recon: FDA rejects Biocon insulin biosimilar; Olympus says it’s fixing issues raised by FDA at Japanese facilities
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Approves Novel Dual Rescue Inhaler for Asthma in Adults (MedPage Today)
- FDA rejects Biocon insulin biosimilar over data, manufacturing concerns (Fierce)
- JPM23: Is GSK’s 15-day accelerated approval withdrawal the new normal? Hear FDA commissioner Califf’s response (Fierce)
- Physicians group urges FDA to convene expert panel before finally approving an Alzheimer’s drug (STAT)
- Lawmakers again urge the Biden administration to use federal law to widen access to a cancer drug (STAT)
- Califf: Decades Of Follow-Up Necessary For Gene Therapy (Pink Sheet)
- Spectrum Labs issues worldwide recall of epinephrine ingredient (Endpoints) (FDAnews)
- Experts talk IRA impacts as CMS announces it will publish first 10 drugs up for negotiation in September (Endpoints)
- How US FDA Must Designate Manufacturing Platforms To Help Speed Approvals (Pink Sheet)
- FDA, NIH: Telehealth Key to Diversifying Trials, But Hurdles Remain (InsideHealth Policy)
- U.S. to announce list of drugs for pricing negotiations Sept. 1 (Reuters)
- Medicare Price Negotiation: Sponsors Will Have A Say, But Likely Not Sway As Timetable Comes Into Focus (Pink Sheet)
- U.S. extends public health emergency status for COVID (Reuters)
- Opinion: for the nation’s health, break up the Food and Drug Administration (Washington Post)
- Olympus says fixing issues raised by U.S. FDA about facilities in Japan (Reuters)
- Canada’s Controversial Pricing Guidelines Suspended (Pink Sheet)
- UK’s NICE Slashes HTA Appraisal Time For Ngenla & Ofev Using New Approach (Pink Sheet)
- WHO issues new warning on Indian cough syrup after 18 more child deaths (Washington Post)
- Mainland Chinese head to Hong Kong for mRNA COVID vaccines (Reuters)
- Uganda declares itself Ebola-free after swiftly turning tide on outbreak (Reuters)
- Feedback Sought On Proposed Regulatory Overhaul In New Zealand (Pink Sheet)
- Illumina to face EU fine of 10% of turnover over Grail deal -sources (Reuters)
- Bayer Gains After Bluebell Said to Build Stake, Eye Breakup (Bloomberg) (Reuters) (Yahoo Finance)
- Merck leads biopharmas in annual ‘just’ business ranking, while GSK and Sanofi nab sustainability honors (Endpoints)
- Eisai chief Ivan Cheung 'not worried at all' about Leqembi's full approval (Endpoints)
- Sanofi extends commitment to $750M biotech startup fund (Endpoints) (Fierce)
- Coherus pays out $32M for exclusive US commercialization rights to Eylea biosimilar (Endpoints)
- Cambrian's anti-aging mission expands with new fibrotic disease biotech (Endpoints)
- Oramed’s Insulin Capsule Fails Its first Phase III Trial (Biospace) (Fierce)
- Vertex Leans into Gene Editing space with Extended Arbor Pact (Biospace)
- JPM23: Samsung plans to kick off antibody-drug conjugate manufacturing in early 2024 (Fierce)
- JPM23: After hiatus, Teva looks to amp up research collaborations, CEO says (Fierce)
- 4D’s Fabry gene therapy founders amid adverse events, further weakening Sangamo’s competition (Fierce)
- BioNTech CEO lays out vision for how mRNA and AI can power personalized medicine (STAT)
- Google sibling Verily to lay off about 200 workers as it focuses on precision risk business (MedTech Dive) (STAT) (Endpoints)
- Rethinking 510(k): Studies show risk of using recalled devices as predicates for FDA clearance (MedTech Dive) (InsideHealth Policy)
- European Commission Invites Comments On Its Critical MDR Proposal (MedTech Insight)
- EU Guidance Details When In-House Devices Are Exempt From MDR and IVDR (MedTech Insight)
- Why Manufacturers Face A ‘Phenomenal Challenge’ In Navigating EU AI Act Regulatory Maze (MedTech Insight)
- Germany’s DRG Reform Must Retain Incentives For Medtech Innovation, Says Industry (MedTech Insight)
- JPM23: What’s medtech’s place at the conference? CEOs from CVRx, Axogen and more weight in (Fierce)
- U.S. judge rules Apple Watch infringed Masimo's pulse oximeter patent (Reuters)
- New Drug Exclusivity Not Impacted By Impurities In Compound, Court Finds In Loss For Sandoz (Pink Sheet)
- Fennec Sues Cipla to Block copies of Lone Drug, Pedmark Infusion (Bloomberg)
- Sterigenics reaches $408M ethylene oxide settlement to resolve hundreds of lawsuits in Illinois (MedTech Dive) (MedTech Insight)
- Bionpharma Antitrust Claims Still Stand in Epaned Patent Suit (Bloomberg)
- Reverse Drug Distributor Wins Appeal of Money Laundering Charge (Bloomberg)
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