Recon: US buys 50M doses of Pfizer vaccine for kids; Biden abandons drug pricing plans
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- Pfizer gets U.S. contract for 50 mln COVID-19 vaccine doses for kids (Reuters)
- Biden abandons his push to lower drug prices (STAT)
- Be careful who you sue: CytoDyn knowingly submitted an incomplete drug application to FDA, new documents show (STAT)
- Merck ready to deploy tens of millions of its Covid antiviral pills if regulators approve, CEO says (CNBC)
- 1.5 million Americans got a Moderna or J&J Covid booster shot in the first 5 days, White House says (CNBC)
- Public-private partnership launched to accelerate gene therapies for rare diseases (STAT) (FDA)
- Feds probe Novartis over Entresto marketing and compensation to doctors (STAT)
- Some immunocompromised people can receive a 4th Covid shot, CDC says (NBC)
- Labcorp raises annual profit forecast as demand for clinical trials rebound (Reuters)
- U.S. CDC panel to discuss COVID-19 shots for younger kids on Nov. 2 (Reuters)
- Up to 50M doses of J&J vaccine sitting idle in factory: report (The Hill)
- EU set to produce over 3.5 billion COVID vaccine doses in 2022 - chief executive (Reuters)
- A cheap antidepressant lowers the risk of Covid hospitalization, a large study finds. (NYTimes)
- WHO, partners seek $23.4 bln for new COVID-19 war chest (Reuters)
- India's Optimus Pharma seeks approval to produce generic Merck COVID-19 pill (Reuters)
- Should I Mix or Match My Booster Shot? (NYTimes)
- HHS unveils drug overdose prevention plan to boost accessibility to care (The Hill)
- Alnylam’s longtime CEO to depart, new leader named (STAT)
- Seagen’s breast cancer drug Tukysa turned down by NICE (Pharmaphorum)
- Looking to win back investor confidence, BioMarin preps for its ‘largest launch’ (Endpoints)
- BMS reports strong growth as its Q3 results beat predictions (PMLive)
- Rafael Pharma drug fails to prolong survival of patients with pancreatic cancer in large study (STAT)
- EMA nod for excessive daytime sleepiness med Ozawade (PharmaTimes)
- FDA+ roundup: CDER's breakthrough designation requests see steep decline in 2021; Drugmakers call to expand FDA guidance on PD-(L)1 dosing (Endpoints)
- A pair of partners at Frazier is following early-stage biotechs to the public market with an $830M fund. And they're already doing deals (Endpoints)
- Koch leads mammoth $215M infusion into AI startup boasting 'largest database' of immune cells (Endpoints)
- Checkmate CEO hits the exit as Art Krieg's crew struggles to warm investors to TLR9 strategy (Endpoints)
- Patients Must Be Warned of Breast Implant Risks, F.D.A. Says (NYTimes) (FDA)
- Northwestern spinout Sibel Health scores FDA clearance for patient monitoring system (MobiHealthNews)
- Latest European Commission Figures Suggest One More IVDR Notified Body In Pipeline And Then A Gap (MedtechInsight)
- AdvaMed Launches Ethics Code To Meet ‘Business & Market Realities’ In India (MedtechInsight)
- Academics Back Illumina's Grail Buy Against FTC Challenge (Law360)
- Regeneron Gets PTAB To Review Syringe Patent On 2nd Go (Law360)
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