Recon: CDC says monkeypox vaccine demand exceeds supply; NIH’s Fauci to retire by end of Biden’s term

| 18 July 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Demand for Monkeypox Vaccine Exceeds Supply, C.D.C. Says (NYT) (Politico)
  • US Buys More Monkeypox Vaccine, Ramps Up Testing as Cases Rise (Bloomberg) (Endpoints)
  • NYC will use a one-dose monkeypox vaccine strategy to stretch supplies, despite FDA, CDC warnings against the move (STAT) (Politico)
  • Covid-19 public health emergency extended in the US (CNN) (WMTV)
  • Pfizer's Hospira issues a recall for a batch of propofol due to a visible particulate (Endpoints)
  • Pfizer celebrates a new FDA approval as the Xalkori franchise slowly winds down (Endpoints)
  • Anthony Fauci to retire by end of U.S. President Biden’s term, Politico reports (Reuters) (Politico)
  • New data might have led to a different result for Amarin fish oil drug, FDA panelists say (STAT)
  • Rx Pricing: Insulin Costs Would Go Up Under Senate Bill; Biden Pushes Summer Action On Broader Plan (The Pink Sheet)
  • House Democrats Pass Post-Roe Abortion Access Legislation (Bloomberg)
  • Major abortion pill maker GenBioPro hires its first lobbyists in Washington (STAT)
  • Cancer Moonshot moves forward with new “Cancer Cabinet’ and goals to reduce cancer (Endpoints)
In Focus: International
  • EU Decision Time For Teclistamab & Seven Other Drugs; Incyte Withdraws Parsaclisib Filing (The Pink Sheet)
  • EU regulator reviews Pfizer-BioNTech COVID shot in children as young as 6 months (Reuters)
  • BeiGene/Novartis's Tislelizumab Faces US Delay Over China Inspection Challenges (The Pink Sheet)
  • EU secures 54,000 more doses of Bavarian Nordic's monkeypox vaccine (Reuters)
  • Analysis: Years of neglect leaves sexual health clinics ill-prepared for monkeypox (Reuters)
  • England’s Innovative Medicines Fund: Opportunities & Risks (The Pink Sheet)
  • A deadly virus was just identified in Ghana: What to know about Marburg (The Washington Post)
  • India’s COVID vaccinations hit 2 billion, new cases at four-month high (Reuters)
Pharma & Biotech
  • Merck’s Potential Buyout of Seagen Likely Delayed Until End of July (Biospace)
  • Merck KGaA kicks off startup collaboration program in Asia (Endpoints)
  • Biotech executives pull in some of health care’s biggest paydays, with Regeneron’s CEO sitting atop the pack (STAT)
  • Cytiva scoops up former Bayer plant in Michigan as part of $1.5B expansion push (Fierce)
  • The top 10 generic drug makers by 2021 revenue (Fierce)
  • As the consumer group splits away today, what will New GSK buy now? (Endpoints)
  • Researchers Find Link Between Heart Disease and Loss of Y Chromosome in Men (Biospace)
  • Straight from science fiction, bacteria-based ‘microrobots’ could become a future cancer treatment (Fierce)
  • GSK's consumer arm Haleon debuts with lackluster valuation (Reuters)
  • Extensive EU Medtech Regulatory Survey Reveals Scale Of MDR Hurdles And Where Problems Lie (MedTech Insight) (MedTech Dive)
  • Roche launches dual antigen and antibody diagnostic test for hepatitis c (Reuters)
  • Industry's Verdict On UK Medtech Regulatory System Progress: 'Could Do Better’ (MedTech Insight)
  • FDA clears wearable neurostimular from DyAnsys to treat pain from diabetic nerve damage (Fierce)
  • FDA Slaps High Risk Class I Label On Recall Of COVID-19 Diagnostics Made In Uncontrolled Plant (MedTech Insight)
  • Medtronic issues EU recall for implantable defibrillators that may not emit strong enough shocks (Fierce)
  • Edwards Lifesciences chief tops lost of highest-paid medical device CEOs (STAT)
Government, Regulatory & Legal
  • Pfizer sues Amgen in effort to invalidate top cancer drug patent (Endpoints)
  • Illumina Settles BGI Patent Battles For $325M (MedTech Insight) (Endpoints)
  • Clinical Labs Win Challenge to Medicare Reimbursement Rule (Bloomberg)
  • Cipla. Boehringer Patents Pact End Runs Would-be Copiers of Ofev (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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