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