Recon: CureVac pulls back its COVID mRNA vax; Medtronic’s new robotics bid

• 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)

In Focus: International

• 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)

Coronavirus Pandemic

• 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)

Pharma & Biotech

• 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)

Medtech

• 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)

Government, Regulatory & Legal

• 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)

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.