Recon: FDA advisors back OTC switch for naloxone; Grifols to lay off 2,000 US staff
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Advisors Endorse Moving Naloxone Over the Counter (MedPage Today) (Reuters) (Endpoints) (Pink Sheet)
- FDA to review Galera’s drug for radiotherapy complication, biotech immediately seeks $30M (Endpoints)
- Pfizer gives interim update on PARP inhibitor combo treatment, earns priority review at FDA (Endpoints)
- Thousands of gene and cell therapies are inundating FDA reviewers as the agency tries to keep up (Endpoints)
- FDA revises action on compounded ibuprofen, citing oral version shortage (Endpoints)
- NIH to Study Shionogi’s Covid Antiviral in Hospitalized Patients (Bloomberg)
- Novavax to provide 1.5M more Covid vaccine doses to the US government (Endpoints)
- Can The Generics Industry Leverage Its COVID Success To Achieve Its Policy Goals? (Pink Sheet)
- Drug prices 'not justified' by pharma R&D spending, new study says (Endpoints)
- FTC Objections To Pharma Mergers Could Go Unchallenged Following Wilson’s Resignation (Pink Sheet)
- Cell And Gene Therapy Outcomes-Based Contracts In Medicaid Need ‘National’ Support,' HHS Says (Pink Sheet)
- In a first, CMS will test paying less for drugs cleared via accelerated approval (Endpoints)
- Pfizer/BioNTech, Moderna gear up for 2024 London trial over COVID vaccine patents (Reuters)
- US International Trade Commission Plans To Review COVID-19 Patent Policy (MedTech Insight)
- Bavarian Nordic acquires travel vaccines from Emergent BioSolutions: expanding US footprint and manufacturing capacity in plan to become of the largest pure-play vaccine companies (Biopharma Reporter)
- EU to phase out COVID tests for travellers from China (Reuters)
- Grifols Slashes 2,000 U.S. Jobs in Efficiency Bid (BioSpace) (Fierce) (Endpoints)
- Merck hands Swedish biotech €10M cash to develop anti-inflammatory drugs (Endpoints) (Fierce)
- Asahi Kasei finishes $96M+ pharma excipient manufacturing plant in Japan (Endpoints)
- Biogen, having ‘lost its way,’ looks to drug launches for Alzheimer’s and depression for return to growth (STAT) (Endpoints)
- Biotech consolidation continues as Nasdaq-listed Erytech merges with phage therapy developer (Endpoints)
- After several flops, Merck exec stands by aggressive Keytruda prostate cancer program (Fierce)
- CRISPR pioneer Feng Zhang launches new genetic delivery startup with $193 million (STAT)
- Newron’s shares accelerate as one-year schizophrenia data boosts chances of historic approval (Fierce)
- GSK vaccine R&D head touts consistency of RSW data but is mum on restarting maternal trial (Fierce)
- Alnylam Vets Raise $193M to Solve Gene Therapy’s Biggest Hurdle – Delivery (BioSpace)
- EU Gives Final Thumbs Up To Altering Transition Deadlines For MDR Legacy Products (MedTech Insight)
- EU Names Ninth Notified Body Under IVD Regulation (MedTech Insight)
- UK Sets Out Landscape For Uptake Of Appropriate Medtech Innovation (MedTech Insight)
- Labcorp forecasts up to 90% fall in COVID testing sales in 2023 (Reuters)
- AI devices need dedicated FDA regulatory pathway to reduce bias risk, say researchers (MedTech Dive)
- Brent Saunders to return as Bausch + Lomb CEO (Reuters)
- Medtronic faces antitrust lawsuit over surgical devices (Medical Design Sourcing)
- Recovering Addict Loses Disability Bias Suit Over Withheld Drugs (Bloomberg)
- American Red Cross Hit With Antitrust Suit Over Blood Safety (Bloomberg)
- US Says It Must Be Target of Moderna Covid-Vaccine Patent Case (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.
