Recon: FDA rejects Biocon insulin biosimilar; Olympus says it’s fixing issues raised by FDA at Japanese facilities

ReconRecon | 12 January 2023 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
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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