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March 22, 2022
by Joanne S. Eglovitch

Recon: FDA approves Merck’s Keytruda for advanced endometrial cancer; Pfizer recalls some BP drug lots due to nitrosamine impurity

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA Approves Merck’s Keytruda for Endometrial Carcinoma (Bloomberg) (Fierce) (Biospace)
  • US FDA Oncology Center Makes Dose Optimization Personal (The Pink Sheet)
  • Pfizer Recalls 6 Lots of Accuretic Tablets, 1 Lot of Quinapril (Bloomberg)
  • Pfizer inks deal with UNICEF to supply Covid pill to poor countries, but advocates say it isn’t enough (STAT) (Bloomberg)
  • White House officials say US has exhausted funds to buy potential fourth vaccine dose for all Americans (Washington Post)
  • Official US Long Covid-19 Data Two Years Away, Hurts Research (Bloomberg)
In Focus: International
  • Lilly, Novartis join drugmakers in scaling back operations in Russia (Reuters) (Endpoints)
  • Janssen’s BCMA-Targeting CAR-T, AstraZeneca’s Evusheld Among EU Verdict Hopefuls (The Pink Sheet)
  • WHO On Dire Need For Essential Medicines In Ukraine (The Pink Sheet)
  • Glaxo Sells $8.75 Billion of Bonds for Consumer Spinoff (Bloomberg)
  • ‘Rising and sustained’ commercial investment in advanced therapy trials in UK (BioPharma Reporter)
  • Younger Females' Cancer Incidence Increases Significantly In China (Scrip)
  • Wockhardt, Serum Institute of India to build UK fill-finish plant in Wales (Endpoints)
Coronavirus Pandemic
  • Omicron sub-variant BA.2 makes up about 35% of COVID variants in U.S., CDC says (Reuters)
  • India considers opening COVID boosters to all adults, sources say (Reuters)
Pharma & Biotech
  • Cadila's sterile injectable site in India hit with a Form 483 following a rare international inspection for FDA (Endpoints)
  • Former Takeda vaccine chief to lead new COVID antiviral venture Aerium (Reuters)
  • Takeda’s Natpara relaunch bid falls flat as manufacturing concerns drag on (Fierce)
  • ‘Harmful and wasteful’: Many pediatric clinical trials end early and don’t report results (STAT)
  • Pfizer, Abbott Labs, AbbVie Legal Chiefs Get Big Pharma Paydays (Bloomberg)
  • With midphase data in hand, MediPrint lands investment to take drug delivery contact lens deeper into the clinic (Fierce)
  • Lonza inks deal with first customer at recently-expanded China manufacturing site (Endpoints)
  • Al Sandrock, former top scientist at Biogen, named CEO at Voyager Therapeutics (STAT)
  • A new cell therapy startup from an immunotherapy pioneer raises $175M in KRAS quest (Endpoints)
Medtech
  • Dexcom's hospital glucose monitor leads latest FDA breakthrough designations (MedTech Dive)
  • FDA labels Philips 2018 field correction for ventilators a Class I recall (MedTech Dive)
  • Essure: Out Of Sight, But Not Out Of Mind For Many Women (MedTech Insight)
  • Minute Insight: Pear Therapeutics Inks Agreement With SoftBank To Develop Japan-Focused Digital Therapeutic (MedTech Insight)
Government, Regulatory & Legal
  • Amgen, Pfizer’s Hospira Settle Neulasta Cancer Drug Patent Suit (Bloomberg)
  • Merck Wins Appeal Over Bid to Arbitrate Vaccine Antitrust Case (Bloomberg)
  • Teva and Allergan reach $107 million deal with Rhode Island over opioid crisis (STAT) (Law360)
  • Seattle-based Covid-19 vaccine developer seeks $950M from Indian partner over trade secret theft (Endpoints)
  • Sona Nanotech Defeats Investors’ Covid Saliva Test Failures Suit (Bloomberg)
  • US appeals court rules in favor of Nevro in patent dispute with Boston Scientific (MedTech Dive)
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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