Recon: Pfizer says vaccine neutralizes Omicron after three doses; FTC settles with Vyera over Daraprim practices

| 08 December 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer, BioNTech vaccine neutralises Omicron with three shots (Reuters) (STAT)
  • Studies suggest Pfizer shot may protect only partially against Omicron (Reuters)
  • Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says (CNBC)
  • AbbVie settles New York opioid case as trial winds down (Reuters)
  • U.S. FTC settles with Vyera over Daraprim, Shkreli trial still on (Reuters) (STAT)
  • New Mexico to join nationwide opioid settlement with drug distributors (Reuters)
  • Elizabeth Holmes denies misleading investors in trial testimony (Reuters)
  • Biogen’s reckoning: How the Aduhelm debacle pushed a troubled company and its fractured leadership to the brink (STAT)
  • Judge blocks Biden’s vaccine mandate for federal contractors (Politico)
  • Lawmakers rush to avert looming Medicare cuts (Politico)
In Focus: International
  • EU expects Europe plants to produce 3.6 billion COVID shots in 2022 (Reuters)
  • S.African health regulator SAHPRA approves Pfizer's booster shots (Reuters)
  • Indian vaccine makers bank on boosters as demand crashes (Reuters)
  • India's SII to halve output of AstraZeneca vaccine as demand sinks - CNBC-TV18 (Reuters)
  • Cancer drug specialist Clinigen latest big UK firm to be taken private (The Guargian)
  • Independent Expert Panel on effective ways of investing in health publishes opinion on European solidarity in public health emergencies (EC)
Coronavirus Pandemic
  • ‘It’s a sore spot’: Why officials are raising questions about Biden’s vaccine donations (Politico)
  • Analysis: Omicron is a wake-up call for COVID-19 vaccine developers (Reuters)
  • Exclusive: Up to 1 million COVID vaccines expired in Nigeria last month (Reuters)
  • Pharmacies slammed with COVID-19 vaccine demand (The Hill)
  • TGA approves booster doses of the Moderna COVID-19 vaccine, SPIKEVAX (TGA)
Pharma & Biotech
  • Teligent, Edge Pharma yank meds on superpotency, sterility concerns (Fierce)
  • Biotech upstart gets $50M to test new virus-based therapies against solid tumors (Endpoints)
  • A high-profile gene therapy biotech takes aim at Huntington's (MedtechDive)
  • Merck KGaA's venture arm is ready to make new investments, raising more than $675M to get things going (Endpoints)
  • Vivo Capital, Bain, Primavera pour $200M into virtually unknown targeted oncology play out of China (Endpoints)
  • Newpath Partners kicks off $350M fund with a wunderkind holding the bag and an all-star scientific team waiting in the wings (Endpoints)
  • Industry Disappointed With England’s Proposed Approach To Innovative Medicines Fund (Pink Sheet)
  • Ex-FDA chief Stephen Hahn lands another new gig, this time as CEO of a cancer testing startup (Endpoints)
  • Stryker Fails To Convince FDA To Exempt Patient-Transport Devices (Medtech Insight)
  • US FDA Proposes Independent Contractor To Track User Fee Dollars Used To Pay FTEs (Medtech Insight)
  • Study links cochlear implants to new bone formation, long-term residual hearing loss (MedtechDive)
  • Find Resources To Designate IVDR Notified Bodies, Commission Tells Member States (Medtech Insight)
  • Boston Scientific Advances First ‘Modular’ Cardiac Rhythm Management System (Medtech Insight)
Government, Regulatory & Legal
  • Centene agrees to pay $28 million to resolve another state probe into its pharmacy benefits business (STAT)
  • Full Fed. Circ. Told Teva Overreacting In Skinny Label IP Case (Law360)
  • Fed. Circ. Won't Revive Teva Challenge To Drug Patent (Law360)
  • Pfizer, ex-employee reach a deal in COVID-19 vaccine trade secrets case (Fierce)
  • Abbott Claims DexCom CGM Suits Renege On Tech-Sharing Agreement (Medtech Insight)
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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