Recon: CureVac pulls back its COVID mRNA vax; Medtronic's new robotics bid
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency (FDA)
- FDA still without a permanent leader as clock ticks down on acting head (CNN)
- IPO floodgates open up after summer lull as five more biotechs file for Nasdaq (Endpoints)
- FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are enough to protect against severe disease (CNBC)
- Moderna and J&J say their data supports COVID vaccine boosters (NPR) (Reuters)
- Texas Gov. Abbott issues order banning Covid vaccination mandates in rebuke of Biden (CNBC) (Reuters)
- Poll: 83 percent support government negotiating drug prices (The Hill)
- FDA Withdrawing Temporary Guidances for Alcohol-Based Hand Sanitizers (FDA)
- EU plans stricter drugs supply rules to avoid reliance on 'autocracies' (Reuters)
- LAV’s Xia parlays gap in kidney therapies into China start-up (BioCentury)
- Aceto keeps up spending spree with acquisition of Ireland's A&C (Endpoints)
- UK drugmaker GSK under fresh pressure to sell consumer arm (Guardian)
- Japanese regulators extend Medical Device Single Audit Program (MDSAP) pilot (Emergo)
- CureVac giving up on first COVID mRNA vax, focusing on GSK-partnered 2nd attempt (NYT) (Fierce)
- EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac AG (EMA)
- India recommends homegrown COVID-19 vaccine for kids aged 2 and above (Reuters)
- Japan working on starting COVID-19 booster shots by year-end (Reuters)
- Scientist behind Merck's Covid pill: We need to watch out for resistance (Endpoints)
- EU may consider deal on Merck's COVID pill after approval procedure begins -source (Reuters)
- GSK and Vir turn to US for distribution as Covid-19 mAb treatment nears blockbuster status (Endpoints)
- A primer on what we know about mixing and matching Covid vaccines (STAT)
- Influenza vaccine with COVID-19 booster shot shows positive results (EPR)
- J&J science chief Stoffels to retire after decade at the top, adding to C-suite changes (Fierce)
- Top Sanofi vaccine execs, Bristol Myers vet chart new path for IGM's antibodies in infectious diseases, autoimmunity (Endpoints)
- Boston biotech backers quit Dana-Farber board after U-turn on investment policy: report (Fierce)
- Amgen reveals new combination data for KRAS inhibitor (PharmaTimes)
- Ocular's Dextenza wins FDA approval as first monthly implant (Fierce)
- Francis Collins’ resignation could complicate the fight over funding for ARPA-H (STAT)
- CRISPR technologies are going to need a bigger toolbox (Nature Reviews)
- Precision medicine data dive shows water pill may be viable to test as Alzheimer’s treatment (NIH)
- Brain atlas unveils dozens of cell types that could inspire targets in neurological disease (Fierce)
- New report shows more than 260 medicines in development to fight neurodegenerative diseases (PhRMA)
- World's First Use of Environmentally Friendly Biomass-based Plastic for Blister Packages (Astellas)
- Novartis’ Baert joins Flagship (BioCentury)
- Alnylam becomes a partner in the Medicines Manufacturing Innovation Centre (Rare Daily)
- With CVR, Pacira’s deal for Flexion could nearly double in size (BioCentury)
- AbbVie’s Qulipta set to become blockbuster in the migraine market (PharmaLive)
- bluebird bio provides update on 2seventy bio spin-off (PMLive)
- FDA breakthrough nods go to liquid biopsies for Alzheimer's, cancer drug response (MedTech Dive)
- Medtronic Just Altered the Surgical Robotics Landscape Forever (MD+DI) (MedTech Dive)
- When Can Investors Expect NuVasive to Get Back on Track? (MD+DI)
- Judge Says Sanofi, GSK, Pfizer, Boehringer Must Face Suits (Legal Reader)
- Prescription Drugs and Class Actions Do Not Mix (Drug & Device Law)
- Could Sponsors’ Supply Chain Policing Have Caught Alleged CRO Fraud? (Pink Sheet)
- Snyders Heart Valve LLC v. St. Jude Medical, LLC (Patent Docs)
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