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)
- 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)
- 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)
- 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)
- 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)
- 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)
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