Recon: FDA advisors back OTC switch for naloxone; Grifols to lay off 2,000 US staff

• 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)