Recon: FDA Commissioner Califf tests positive for COVID; Veru surges on hopes for COVID drug EUA

ReconRecon | 08 November 2022 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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