Recon: FDA grants priority review to Sanofi’s hemophilia A drug; Pfizer invests $500M in decentralized drug development initiative

ReconRecon | 30 August 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Sanofi, seeking to stem bleeding at hemophilia A unit, gets FDA priority review for rival to Roche (Fierce) (MedWatch)
  • FDA Partially Clears Curis Leukemia Trial in Second August Regulatory Win (BioSpace)
  • Republican Senators Ask Biden for ‘Operation Warp Speed 2.0’ (Bloomberg)
  • Latest Covid-19 shots are almost ready: Why is the US authorizing a different booster than the rest of the world? (Endpoints)
  • FDA Opens Review into Opioid Prescribing, Warning Regulations (Bloomberg)
  • A Pivotal September For US FDA And Commissioner Califf (Pink Sheet)
  • US FDA Quashes Citizen Petition Against Bluebird’s Zynteglo That Cited Patent, Safety Concerns (Pink Sheet)
  • Biden's Abortion Strategy Omits Regulatory Changes That Could Boost Mifepristone Access (Pink Sheet)
  • US FDA Denies Petition Seeking Freeze On Russian Companies' Regulatory Activities (Pink Sheet)
  • Texas reports death tied to monkeypox, a first in the U.S. (STAT) (The Hill)
In Focus: International
  • EU Promises ‘Unifying’ Stakeholder Forum To Discuss Changes To Clinical Trial Landscape (Pink Sheet)
  • China's DNA giant confronts skepticism in US expansion bid (Endpoints)
  • COVAX to send Mexico 10 mln COVID shots by Sept. 30, says official (Reuters)
  • How Africa Can Meet Its Daunting Production Challenge For Critical Disease Vaccines (Pink Sheet)
  • Monkeypox outbreak can be eliminated in Europe, WHO says (Reuters)
Pharma & Biotech
  • Pfizer buys into decentralized cooperative to accelerate R&D in human longevity (Endpoints) (BioSpace)
  • Novartis to shutter NC-based Sandoz plant ahead of spinoff (Endpoints)
  • With $50M, Vilya’s Peptides Aim to Transcend Cells’ Lipid Membrane (BioSpace)
  • Arch builds bridge to new class of medicines, leading $50M investment in the AI-enabled Vilya (Fierce)
  • Another UK Biotech Snapped Up As Neurocrine Buys Diurnal (Scrip)
  • AstraZeneca’s Pascal Soriot says Covid-19 boosters may not be for everyone — report (Endpoints)
  • SaNOtize bags $24M to fund phase 3 trial of COVID-19 nasal spray (Fierce)
  • Four years and $145M+ later, Novo Nordisk hands back the rights to hormone growth deficiency test (Endpoints)
  • Glaukos pays iVeena $10M for eye drop vision loss candidate (Fierce)
  • West Pharma’s $65M plant expansion to create 225 new jobs (Fierce)
  • BioSpace Layoff Tracker 2022: Codiak Restructures, Novartis Closing Sandoz NC Facility  (BioSpace)
  • After clinical hold quashed its hopes, Yumanity fielded 10 bidders before landing on two-way deal with J&J, Kineta (Endpoints)
  • Cleaning house: Scientists find genetic quirk may help clear out beta amyloid, treat Alzheimer’s (Fierce)
  • For the ‘godfather’ of biotech, saving Biogen is the final act of a singular career (STAT)
  • MDCG Listens To Industry Over New Medtech Regulation Hurdles And Publishes 19-Point Action Plan (MedTech Insight)
  • FDA clears BrainsWay’s 2nd neurostimulation approach to depression treatment (Fierce)
  • Phillips adds yet another ventilator recall to the docket, citing contaminated plastic (Fierce) (MedTech Dive)
  • Intera Infusion Pumps Recalled For Too-Fast Flow (MedTech Insight)
  • Recall Watch: Hamilton ventilator, Intera pump recalls get Class I label from FDA (MedTech Dive)
Government, Regulatory & Legal
  • Otsuka, Lundbeck Sue Viatris Again on Abilify Maintena Copy (Bloomberg)
  • Pharma's day in court: Is the daily downpour of lawsuits giving pharma companies a bad rep? (Endpoints)
  • In a new lawsuit, pharma-backed patient groups fight federal rule around copay coupons (STAT)
  • Novartis’ Entresto Drug Is Target of Universities’ Patent Suit (Bloomberg)
  • Becton Dickinson Must Pay $4.8 Million Over Hernia Mesh Claims (Bloomberg)
  • Beech-Nut Says Baby Food Lawsuit ‘Needlessly Distressed’ Parents (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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