Recon: FDA Commissioner Califf tests positive for COVID; Veru surges on hopes for COVID drug EUA
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- U.S. FDA commissioner Robert Califf tests positive for COVID (Reuters) (FDA)
- Pfizer’s Covid Cash Powers a ‘Marketing Machine’ on the Hunt for New Supernovas (KHN)
- After years of lax oversight, the NIH is starting to contact institutions about unreported clinical trial results (STAT)
- Amid concerns over U.S. democracy, pharma helped finance committees that support election deniers (STAT)
- FDA places clinical hold on Verve Therapeutics gene-editing treatment (STAT)
- FDA staff flags uncertainties on Veru's COVID drug; EUA hopes lift shares (Reuters)
- Novavax says Omicron shot shows strong immune response as second booster (Reuters)
- U.S. Supreme Court rejects Bristol Myers cancer-drug patent fight with Gilead (Reuters)
- Paxlovid May Reduce Risk of Long Covid in Eligible Patients, Study Finds (NYTimes)
- Novartis adds 50 million euros to European antibiotics investment budget (Reuters)
- BioNTech executive says it is too early to predict China vaccine approval (Reuters)
- Pill to prevent pre-eclampsia gets UK fast track for development (The Guardian)
- Lab-grown blood given to people in world-first clinical trial (BBC)
- BioNTech lifts lower end of vaccine sales target range (Reuters)
- EU Pharma Legislation Overhaul To Lower IP Protection, Warns Industry (Pink Sheet)
- J&J’s Mammen out of the running for Biogen CEO post (STAT)
- New drug may help people with uncontrolled high blood pressure (NBC)
- Novartis to lay off 275 in Libertyville, IL (Daily Herald)
- Indian govt pushes to curb freebies for doctors (Mint)
- US to boost medication access to tackle opioid overdose crisis (FT)
- Merck’s Keytruda receives NICE recommendation as breast cancer treatment option (PMLive)
- AstraZeneca’s Farxiga shows benefits for heart failure patients in phase 3 trial (PMLive)
- Another roadblock looms for BioMarin's hemophilia A gene therapy — but it might not take too long (Endpoints)
- Kura Oncology secures up to $150M in Bristol Myers equity investment, loan from Hercules Capital (Endpoints)
- For $700M+, Viatris nabs two biotechs as eye disease emphasis comes into view (Endpoints)
- As Roche prepares to take a kidney disease drug into PhIII, Ionis fleshes out the data (Endpoints)
- ONO exercises Fate CAR-T option in latest twist to partners' four-year deal (Endpoints)
- Scoop: A SoftBank-backed biotech raises more funds after bagging $100M+ for fungi mining (Endpoints)
- Lonnie Moulder’s new biotech play grabs $118M, steering into PhIII and more deals (Endpoints)
- With all hands on deck for lead sickle cell trial, Beam pulls back clinical plans for second base editing therapy (Endpoints)
- Medtronic Blood-Pressure Device Curbs Hypertension, but Misses Top Goal in Study (WSJ)
- Five takeaways from the FDA’s list of AI-enabled medical devices (MedtechDive)
- Embecta to add Intuity’s automatic, push-button glucose reader to its sales catalog (Fierce)
- UK Trials Reimbursement Of Digital Self-Help Apps For Children With Anxiety (MedtechInsight)
- iRhythm analysis shows savings from patients wearing Zio XT cardiac monitor patch (MedtechDive)
- Teleflex recalls 61K breathing system filters, prompting FDA Class I designation (Fierce)
- FDA and PTO look to shore up inconsistencies around pharma patents (Endpoints)
- Patent wars: Moderna’s battle for the spoils of Covid vaccines (FT)
- Alcon Gets PTAB Win In Eye Surgery IP Fight With J&J Unit (Law360)
- FDA Warns Court Not To Side With Sandoz In Drug Challenge (Law360)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
