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December 24, 2020
by Michael Mezher

Recon: Brexit trade deal reached; FDA places Altimmune COVID vaccine trial on hold

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Federal judge places restraining order on Trump’s latest drug pricing rule (STAT) (Reuters)
  • FDA puts early-stage trial of Altimmune's COVID-19 vaccine on hold (Reuters)
  • Nearly 9.5m doses of COVID-19 vaccines distributed, 1 million administered (Reuters) (CNBC)
  • Coronavirus aid at risk as US lawmakers block Trump's changes (Reuters)
In Focus: International
  • A Brexit trade deal at last: EU and UK clinch narrow accord (Reuters) (NYTimes)
  • UK parliament to vote on Brexit deal on Dec. 30 (Reuters)
  • Brazil institute says CoronaVac efficacy above 50%, but delays full results (Reuters)
  • Logistics firms reap "vaccine economy" benefits as EU gears up for roll-out (Reuters)
  • Aurobindo Pharma to make COVAXX's potential COVID-19 vaccine for India, UNICEF (Reuters)
  • South Korea to import J&J, Pfizer COVID-19 vaccines for 16 million people (Reuters)
  • Another new coronavirus variant found in Nigeria, says Africa CDC (Reuters)
Coronavirus Pandemic
  • How a British COVID-19 vaccine went from pole position to troubled start (Reuters)
  • Census armies pivot to vaccine outreach with minorities (Politico)
  • Analysis: Some Said the Vaccine Rollout Would Be a ‘Nightmare.’ They Were Right. (KHN)
  • First Pfizer vaccines arrive in Chile, medics to be inoculated first (Reuters)
Pharma & Biotech
  • Pandemic Spurs Deepening of Pharmacopoeia/Regulator/Industry Communication Channels (IPQ)
  • What did Endpoints News readers find as the most compelling features of a momentous 2020? Here are the top 10 (Endpoints)
  • Roche gets EU approval for fixed-dose Herceptin/Perjeta combination (PMLive)
  • Amgen files KRAS inhibitor sotorasib with EMA (PharmaTimes)
  • Vivek Ramaswamy's 'vant' brainchildren keep bearing fruit with Urovant's FDA nod for incontinence med vibegron (Endpoints)
Medtech
  • FDA authorizes marketing of new device designed to remove dead pancreatic tissue (FDA)
  • Recall Of Cook Medical Catheters Labeled High-Risk Class I By FDA (MedtechInsight) (FDA)
  • Carmat To Launch Total Artificial Heart In Early 2021 (MedtechInsight)
Government, Regulatory & Legal
  • Supreme Court Verdict In Patent Case Could Cause ‘Unprecedented Nightmare Scenario’ For Industry (MedtechInsight)
  • Australian regulator rejects Google’s Fitbit undertaking, delays acquisition decision (mobihealthnews)
  • AbbVie Tells 7th Circ. Asserting Rights Isn't 'Patent Thicket' (Law360)
  • Canopy Slaps GW With Patent Suit Over Flagship CBD Drug (Law360)
  • Regulator Performance Framework: Self-assessment report, July 2019 to June 2020 (TGA)
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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