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