Recon: Pfizer’s maternal RSV vaccine headed to FDA after hitting study endpoints; J&J to acquire heart pump maker Abiomed for $16.6B

ReconRecon | 01 November 2022 |  By 

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