Biden’s ready to start his pandemic response immediately (STAT)
As Nation Awaits Vaccine, Biden Is Under Pressure to Name New FDA Chief ASAP (KHN)
‘They’re not really doing anything’: As Covid-19 cases spiral, leaders around the U.S. lose urgency on prevention (STAT)
US pharma industry responds to American election result (EPR)
U.S. crosses 10 million COVID-19 cases as third wave of infections surges (Reuters)
Experts warn of worsening pandemic unless Trump takes action (The Hill)
Biden Administration May Push Rx Pricing To Back Burner With Senate That Stays Pharma Friendly (Pink Sheet)
What Did US FDA Do Wrong in Its Review Of Aducanumab? AdCom Members Have A List (Pink Sheet)
Trump tried to justify rising Covid cases by pointing to Europe. Experts say he's wrong. (NBC)
Six in White House, Including Trump’s Chief of Staff, Have the Coronavirus (NYT)
In Focus: International
COVID-19 vaccine could fundamentally change pandemic direction: WHO (Reuters)
UK says expects to receive 10 million doses of Pfizer/BioNTech vaccine this year (Reuters)
UK and EU agree on phased process for Northern Ireland medicines regulation (Pharmatimes)
NICE launches consultation on its methods of drug evaluation (PMLive)
Regulatory information – 1.7% and 1.6% increase of pharmacovigilance fees from 1 November 2020 (EMA)
UK urged to stockpile medicines to confront Covid and Brexi (FT)
Head of UK’s COVID-19 vaccine taskforce faces questions over biotech fund (Pharmafile)
Bidencare, a boost for Indian pharmaceutical companies (Economic Times)
As Covid-19 runs riot across the world, China controls the pandemic (NBC)
Coronavirus Pandemic
'Great day for humanity': Pfizer says COVID-19 vaccine over 90% effective (NYT) (Reuters) (STAT) (Endpoints) (NBC) (NPR)
Health experts want to prioritize people of color for a Covid-19 vaccine. But how should it be done? (STAT)
Factbox: Development of Pfizer-BioNTech coronavirus vaccine (Reuters)
Novavax on track to begin U.S. trial of COVID-19 vaccine this month (Reuters)
Russia's Sputnik V vaccine also over 90% effective: health ministry (Reuters)
Recommendations for fair and regulated access to a COVID-19 vaccine (AAAS)
CVS CEO: Pharmacies Ready To Distribute Covid-19 Vaccines Once Approved (Forbes)
First patient dosed with AgenTus’ cell therapy designed to clear COVID-19 virus while reducing inflammation (BioPharma Reporter)
Pharma & Biotech
Biogen plunges 30% after FDA panel votes against Alzheimer's drug (Reuters)
GSK reports its long-acting HIV PrEP tops Gilead's Truvada — again (Endpoints)
Excipient developers call for regulatory facelift (Nature)
Bristol Myers posts a win for their Otezla competitor in psoriatic arthritis (Endpoints)
Legend Biotech has a new chairwoman and permanent CEO. But where is Frank Zhang? (Endpoints)
Opdivo plus Yervoy combo approved in EU for first-line lung cancer (PharmaTimes)
Patient enrollment bounces back to pre-COVID number: survey
US green lights AZ’s Brilinta to reduce risk of stroke (PharmaTimes)
Vifor Builds Its Kidney Disease Focus With $80m Angion Deal (Scrip)
First patient dosed in COVID-19 trial with allogeneic cell therapy (EPR)
Sanofi Hampered By Fitusiran Clinical Hold In Hemophilia (Scrip)
RemeGen grabs one of the world's largest ever biotech IPOs (Fierce Biotech)
Medtech
Philips Stellarex Data Furthers Confidence in Paclitaxel Devices (MD+DI)
Zimmer Biomet shares early data on Apple Watch app for recovery after knee surgery (MedCity News)
What Intuitive is looking for through its new $100M venture fund (MD+DI)
Government & Regulatory
The Affordable Care Act Faces Another Supreme Court Test (NYT) (KHN)
A scalpel, a bulldozer and the Affordable Care Act (SCOTUS Blog)
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.
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