Recon: Pfizer’s maternal RSV vaccine headed to FDA after hitting study endpoints; J&J to acquire heart pump maker Abiomed for $16.6B
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Accuracy of Pulse Oximeters to Get Close Look From FDA Advisors (MedPage Today)
- Califf: Potential benefits of Twitter exceed risks (Politico)
- FDA to Update Expanded Access Guidance With Review Board Details (Bloomberg)
- Y-mAbs’ I-Omburtamab Offers Another Example Of The Limits To US FDA’s Regulatory Flexibility (Pink Sheet)
- US FDA’s ODAC: The Advisory Committee That Can Only Say ‘No’ (Pink Sheet)
- November Gloom? US FDA’s Goal Dates Include Hard Calls On Ferring Rebyota, Y-mAbs’ Omblastys (Pink Sheet)
- U.S. FDA warns of tracheostomy tube shortage (Reuters)
- Amicus’ Pompe approval hopes stall after COVID scuttles WuXi FDA inspection (Fierce)
- GOP Congress Takeover Would Stymie Biden, Offer Business a Reset (Bloomberg)
- CDC Director Walensky Has Covid Rebound After Paxlovid Treatment (Bloomberg)
- EU Guidance To Tackle Sponsor/Investigator Overlap In Decentralized Trials (Pink Sheet)
- Australia To Speed Up Post-Market Reviews Of Reimbursed Drugs (Pink Sheet)
- WHO says monkeypox remains global health emergency (Reuters)
- In Africa's monkeypox outbreak, sickness and death go undetected (Reuters)
- Malawi cholera death toll rises to 180 (Reuters)
- Italy delays EU-required justice reform, scraps vaccine mandate for medics (Reuters)
- Pfizer’s phase 3 maternal RSV vaccine trial hits at interim review, prompting early stop and race to FDA (Fierce) (Reuters) (Biospace) (STAT)
- Pfizer boosts COVID vaccine sales forecast by $2 bln (Reuters)
- Pfizer discards eczema, NASH and breast cancer programs in early-phase clean-out (Fierce)
- Bristol Myers' blockbuster-to-be Reblozyl scores a PhIII win (Endpoints)
- Drug shortages aren’t going away any time soon, supply chain expert warns (Fierce)
- Lilly pumps $50M into Purdue pact to study intrathecal and nanoparticle drug delivery (Fierce)
- Lilly gives up on $40M BCL-2 buy as part of latest pipeline cull (Fierce)
- Eli Lilly's bleak annual forecast overshadows quarterly beat (Reuters)
- Actinium’s radiotherapy spooks AML in elderly patients, prompting a sweet tooth for regulatory approval (Fierce)
- BioCryst leaves ultra-rare bone disease efforts in hands of Ipsen, Regeneron with discontinuation (Fierce)
- Covid-19 spurred a historic vaccine R&D effort. What does it mean for future pandemics? (Endpoints)
- Contract manufacturers will still be navigating global challenges into next year (Endpoints)
- Annual report shows ‘moderate outlook’ and focus on mRNA (Endpoints)
- How to Attract and Keep Top Talent in the Biopharma Industry (Biospace)
- Under hub-and-spoke biotech, serial founders launch new startup hoping to make gene therapies for the eye (Endpoints)
- Autoreceptor absence fuels dopamine dysregulation in schizophrenia (Fierce)
- Monoclonal Antibody Shows Protection Against Malaria (MedPage Today) (Washington Post)
- J&J to buy heart device maker Abiomed for $16.6B in year’s largest medtech deal (MedTech Dive) (Reuters) (Bloomberg) (Biospace)
- Abiomed scores FDA approval for easier-to-wear pump for right-side heart failure (Fierce)
- OTC hearing aid maker Nuheara gets 510(k) clearance for HP-branded device, undercuts Lexie, Sony on price (MedTech Dive)
- UK’s AI Workforce Plan: ‘Shapers’ To Determine Regulation And Guidance For NHS (MedTech Insight)
- Gilead Must Post $14M To Keep Ban On Generic Lexiscan (Law360)
- AbbVie puts up fight against Orilissa generics from Sandoz, Teva and others (Endpoints)
- GSK’s ViiV Sues Exavir Over Licensing Pact on HIV-Drug (Bloomberg)
- Walmart ‘Non-Drowsy’ Cough Medicine Suit Barred by Federal Law (Bloomberg)
- Alcon Sues Padagis to Block Copies of Simbrinza Eye Drops (Bloomberg)
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