Recon: Elizabeth Holmes found guilty of four counts of fraud; Another big Paxlovid deal

ReconRecon | 04 January 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • More than 1 million Americans were diagnosed with COVID over the long holiday weekend (NPR) (Reuters)
  • Elizabeth Holmes is found guilty of four counts of fraud (NYT) (POLITICO)
  • The Epic Rise and Fall of Elizabeth Holmes (NYT)
  • Pfizer carries pandemic momentum into 2022, scoring another huge Paxlovid deal with the US (Fierce)
  • CDER, CBER Approve Total of 60 New Products in 2021, Despite Challenges (CHC)
  • Former FDA Commissioner Crawford dead at 83 (BioCentury)
In Focus: International
  • MHRA grants approval for Pfizer’s oral COVID-19 antiviral pill (PharmaTimes)
  • Health Canada Launches Electronic Manufacturer's Certificate to Export (Health Canada)
  • WHO sees more evidence that Omicron causes milder symptoms (WHO)
Coronavirus Pandemic
  • CDC Might Recommend Asymptomatic People Test Negative For COVID-19 Before Breaking Isolation (BuzzFeed)
  • CDC: If you got Pfizer’s vaccine, seek a booster 5 months after the second shot, not 6 (NYT)
  • Omicron estimated to be 95.4% of coronavirus variants in U.S. – CDC (Reuters)
  • Dr Reddy's to launch generic COVID-19 Merck drug at about 50 cents a pill (Reuters)
  • Novavax gathers its COVID-19 vaccine data for long-delayed FDA filing (Fierce)
  • Retailers hike COVID-19 test prices after White House deal expires (The Hill)
  • Fourth COVID-19 vaccine dose boosts antibodies five-fold in Israeli study, PM says (Reuters)
Pharma & Biotech
  • Biotech pulls plans to file accelerated approval after FDA 'change in direction' (Endpoints)
  • Biogen bets $60M upfront that a new antisense candidate from Ionis can one-up Spinraza (Endpoints) (BioPharma Dive)
  • Biogen and Eisai move forward with investigational Alzheimer's therapy (BioPharma Reporter)
  • Applied Therapeutics tried to muzzle short sellers — but the truth still came out (STAT)
  • FDA’s vaccines and biologics chief talks Covid-19, 2022 priorities, and getting back to gene, cell therapy review (STAT)
  • Aetion snaps up synthetic real-world data company Replica Analytics (Mobi Health News)
  • Exelixis nabs Merck veteran as chief medical officer on quest to expand its R&D footprint (Fierce)
  • With $415M on the line, Genmab taps Synaffix for antibody-drug conjugate technologies (Fierce)
  • Company Quick Takes: TandemAI seeded with $25M (BioCentury)
  • Ovid Therapeutics adds to epilepsy drug pipeline with new AstraZeneca alliance (MedCity News)
  • Transatlantic VC veterans tap Novo Holdings to raise $124M rare disease fund (Fierce)
  • FDA OKs Endogenous Cushing's Syndrome Treatment (MedPage Today)
  • Pfizer, GSK and Teva lead 2022's round of January drug price hikes: GoodRx (Fierce)
  • Texas is trying to create the next research triangle for biotech. Will it work? (STAT)
  • Biomedical Research Leads Science’s 2021 Breakthroughs (NIH Director’s Blog)
  • Why are not There More Bayesian Clinical Trials? Perceived Barriers and Educational Preferences Among Medical Researchers Involved in Drug Development (PubMed)
  • Medtech's biggest deals in 2021 and what to expect next (MedTech Dive)
  • 5 predictions for how technology will transform healthcare in 2022 … and beyond (MedCity News)
  • Health tech needs to rebuild trust in the wake of the Theranos verdict (STAT)
  • Reducing Maternal and Newborn Deaths in Kenya through Medtech (MD+DI)
  • A New Year, A New Spin Off (MD+DI)
Government, Regulatory & Legal
  • All Too Few (2-Year Version) or Where Have All the COVID Tests Gone? A Review of FDA’s Policies (FDA Law Blog)
  • Covid-19 politics force state lawmakers to ponder pharma campaign cash (STAT)
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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