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Recon: EU agencies recommend mix-and-match COVID vaccines; Biden touts drug pricing plans in social spending bill

Posted 07 December 2021 | By Michael Mezher 

Recon: EU agencies recommend mix-and-match COVID vaccines; Biden touts drug pricing plans in social spending bill

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Biden touts drug pricing plan in push for social spending bill (Politico) (NYTimes)
  • J&J squares up to Big Pharma rivals with extra RSV vaccine data (Fierce)
  • Former Pharma Executive Charged With Embezzling Millions (AP)
  • Flagship to launch a new startup focused on neurodegenerative conditions, including Parkinson’s (STAT)
  • Targeting prices for accelerated approval drugs may have limited impact on overall drug spending (STAT)
In Focus: International
  • Doubts over efficacy of Chinese vaccines stoke anxiety at home and abroad (FT)
  • New data shows GSK-Vir drug works against all Omicron mutations (Reuters)
  • EU agencies endorse mix-and-match of COVID-19 vaccines (Reuters) (EMA)
  • Mixing Pfizer, AstraZ COVID-19 shots with Moderna gives better immune response -UK study (Reuters)
  • WHO advisory group looking at 'mix and match' COVID-19 vaccines (Reuters)
  • Novavax COVID-19 vaccine could be approved very soon, says EMA chief (Reuters)
  • GlaxoSmithKline, Medicago hit 75% efficacy against delta COVID strain, but omicron muddies waters (Fierce)
  • AstraZeneca wagers $200M on Ionis' next chance at a rare disease drug (BioPharmaDive)
  • EU may face shortage of key materials for diagnostics, cancer treatments (Reuters)
  • Africa needs to make own vaccines but hurdles are high, experts say (Reuters)
Coronavirus Pandemic
  • Vaccine mandates 'absolute last resort', WHO Europe head says (Reuters)
  • An advocacy group seeks to broaden access to a Pfizer Covid-19 pill (STAT)
  • FDA spots 26 tests where omicron detection requires further confirmation (Fierce)
Pharma & Biotech
  • Robert Califf’s Chance To Make History At The US FDA (Pink Sheet)
  • Recursion loops in Roche, Genentech for multibillion-dollar AI drug discovery deal (Fierce)
  • US FDA Vaccination Rate Exceeds 96%, But Will It Lead To More In-Office Work? (Pink Sheet)
  • Merck pauses 2 more trials of backbone HIV drug over red flag, raising doubts about multipronged R&D strategy (Fierce)
  • A serial biotech entrepreneur launches his next startup with high-dollar backing (BioPharmaDive)
  • Alvotech, battling AbbVie over its Humira biosim, raises $450M and tees up Nasdaq debut (Fierce)
  • Acadia touts late-stage win for its Rett syndrome drug, edging out a lead against its competitors (Endpoints)
  • Can a new European biotech make an ADC better than Padcev? Investors are putting up almost $100M to find out (Endpoints)
  • 'We're in': Roche and Genentech join forces on a multibillion-dollar discovery pact with a brash AI upstart (Endpoints)
  • Icelandic billionare's biosimilar company raises $450M, preps for Nasdaq launch with SPAC merger (Endpoints)
  • Tandem Diabetes Care targets 1M customers by 2027 (MedtechDive)
  • Cancer treatments lead latest FDA breakthrough device designations (MedtechDive)
  • Insulet Omnipod 5 insulin pump clearance delayed to 2022: CEO (MedtechDive)
  • Freenome one-ups itself with $300M from GV, Roche and more to expand cancer blood test platform (Fierce)
Government, Regulatory & Legal
  • Justices Told Fed. Circ. Wrongly Kills Patents PTAB Upholds (Law360)           
  • OIG Still Wary Of Anti-Kickback Safe Harbors For Value-Based Arrangements Involving Drugs (Pink Sheet)
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.


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