Recon: Pfizer begins Paxlovid trial in high-risk children; Aspen to supply own branded version of COVID vaccine in Africa

ReconRecon | 09 March 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer begins COVID pill study in high-risk children aged 6-17 (Reuters)
  • Pfizer To Submit Data to FDA on Fourth Shot Soon, CEO Says (Bloomberg) (Seeking Alpha)
  • Sanofi, scarred by Roche scrap, hits goal in once-weekly hemophilia A trial and plots race to regulators (Fierce) (BioSpace)
  • Republicans Plan Own Bill to Revamp Speedy Drug Approvals (Bloomberg)
  • More Covid Money Urged to Make Up for Funding Bill’s Shortfall (Bloomberg) (Endpoints)
  • Merck’s Molnupiravir And The Meaning Of ‘Access’ (The Pink Sheet)
  • AbbVie settles one of its final Humira biosimilar suits for another mid-2023 delayed entry (Endpoints) (STAT) (Bloomberg)
  • Patient in Groundbreaking Heart Transplant Dies (NYT) (Washington Post) (The Hill)
  • Congress moves toward giving FDA authority over synthetic nicotine products like Puff Bar (STAT) (Washington Post)
In Focus: International
  • Moderna’s new patent policy is a mixed blessing for WHO effort to replicate its Covid-19 vaccine (Endpoints)
  • NICE Says No To Keytruda For Triple-Negative Breast Cancer (The Pink Sheet)
  • S.Africa's Aspen to supply its own branded COVID-19 vaccine by June (Reuters)
  • S.Africa's Aspen Pharmacare reports 37% rise in half-year profit (Reuters)
  • Indian companies stay put in Russia but pharma exports could be hit (Reuters)
Pharma & Biotech
  • Sanofi CEO Paul Hudson sketches a $1B-plus investment on its new mRNA center (Endpoints)
  • Novo Nordisk extends innovative drug delivery research tie-up with MIT and BWH (BioPharma Reporter)
  • Amgen gets the dirt flying on its new $550M manufacturing site as pharma building booms in NC (Endpoints)
  • COVID-19: How Staff At Belgium’s Medicines Agency Dealt With The Challenges – And The Stress (The Pink Sheet)
  • One-stop-shop CDMO to support manufacturing of AAV-based product targeting Alzheimer’s disease  (BioPharma Reporter)
  • J&J’s long-acting injectable push barrels forward as it adds 2nd large molecule to Midatech pact (Fierce)
  • EMA To Be Flexible On Best Time To Enter PRIME Scheme Regardless Of Company Size (The Pink Sheet)
  • Gilead’s Dan O’Day is pharma’s most charming executive — but with his deals falling apart, charm may not be enough (STAT)
  • Exclusive: ARCH and GV are building a large startup focused on mitochondrial diseases (Endpoints)
  • Kurma scores $175M in first closing of biotech/healthtech fund — the VC's largest yet (Endpoints)
  • FDA warns of cyber vulnerabilities in medical device software components (MedTech Dive)
  • Medtronic, Nevro boosted by expansion of Medicare coverage for diabetic pain devices (MedTech Dive)
  • Inspirata’s pathology software nets FDA clearance for use with multiple slide scanners (Endpoints)
  • Saluda’s spinal cord stimulation system scores FDA approval for chronic pain (Fierce)
  • On Medtronic’s tail, Axonics scores FDA nod for 15-year neurostim implant for incontinence (Fierce)
  • Silicon Valley Bank Advisor Predicts 2022 Will Be Year For Healthtech, Massive Consolidation (MedTech Insight)
  • Intuitive CEO on labor shortages, placements amid the pandemic, new competition (MedTech Dive)
  • Updated Endoscope Cleaning Guidance Urges Move From Manual Cleansing To Sterilization (MedTech Insight)
Government, Regulatory & Legal
  • Sanofi Stuck With Taxotere Retrial as 5th Cir. Refuses New Look (Bloomberg)
  • Boston Scientific Patent Argument ‘Stupid,’ Fed. Cir. Judge Says (Bloomberg)
  • J&J Judge Appoints Two Mediators for Baby Powder Bankruptcy Case(Bloomberg)
  • UnitedHealth’s HIV Drug Suit Against Teva, Gilead Trimmed (Law360)
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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