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Regulatory Focus™ > News Articles > 2020 > 10 > Recon: Pfizer won’t seek vaccine EUA before election; WHO trial finds remdesivir has little effect o

Recon: Pfizer won’t seek vaccine EUA before election; WHO trial finds remdesivir has little effect on COVID mortality

Posted 16 October 2020 | By Michael Mezher 

Recon: Pfizer won’t seek vaccine EUA before election; WHO trial finds remdesivir has little effect on COVID mortality

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer Says It Won’t Seek Vaccine Authorization Before Mid-November (NYTimes) (Reuters) (Politico)
  • Trump’s election-eve drug discounts for seniors get snagged (AP)
  • NIH to Study Three Drugs in Treatment of Covid-19 Patients (WSJ) (Reuters)
  • It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN (CNN)
  • US Investigates Vaxart’s Claims Related to Covid-19 Vaccine (NYTimes)
  • Attorneys general urge the Justice Department to revise a settlement deal with Purdue (STAT)
  • Facing Many Unknowns, States Rush To Plan Distribution Of COVID-19 Vaccines (NPR) (The Hill)
  • Analysis: Sales of first big COVID-19 drug, remdesivir, may disappoint (Reuters)
  • The ‘nerdy virologists’ steering the US vaccine race (Politico)
In Focus: International
  • Remdesivir Fails to Prevent Covid-19 Deaths in Huge Trial (NYTimes) (FT) (WHO)
  • Row breaks out over WHO trial casting doubt on remdesivir as COVID-19 drug (Reuters)
  • First remdesivir prequalified (WHO)
  • EU urged to review remdesivir supply deal after COVID trial results (Reuters)
  • EU medicine agency could approve COVID-19 vaccines early next year (Reuters) (ANSA) (Sky)
  • Britain moves closer to COVID-19 vaccine trials that infect volunteers (Reuters)
  • PharmaMar plans phase III trial of cancer drug for COVID-19, shares jump (Reuters)
  • Sinovac coronavirus vaccine offered by Chinese city for emergency use costs $60 (Reuters)
  • Fujifilm seeks approval for Avigan as COVID-19 treatment in Japan (Reuters)
  • Novartis sees EU OK ahead after panel nod for $10 bln anti-cholesterol prospect (Reuters)
  • EMA cancer symposium: New approaches in patient-focused cancer medicine development (EMA)
Coronavirus Pandemic
  • Vast majority of air cargo companies are unprepared to transport Covid-19 vaccines (STAT)
  • How Bad Will Coronavirus Be This Winter? Model Projects 170,000 More U.S. Deaths (NPR)
  • Fujifilm to help Lilly make COVID-19 antibody drug (BioPharmaDive)
  • A rare Covid-19 complication was reported in children. Now, it's showing up in adults. (NBC)
  • FDA Reissues Emergency Use Authorization for Certain Non-NIOSH-Approved Filtering Face-Piece Respirators Manufactured in China (FDA)
Pharma & Biotech
  • Drug May Extend A.L.S. Patients’ Lives by Several Months, Study Finds (NYTimes)
  • Disarm Therapeutics bought by Lilly for $135 million (STAT)
  • FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid (FDA)
  • GlaxoSmithKline offloads Polish plant with 700 workers to French CDMO Delpharm (Fierce)
  • UCB sketches grand plans for new headquarters as it grabs Eli Lilly's abandoned neuro R&D campus (Endpoints)
  • US FDA Has Done Over 200 ‘Mission Critical’ Inspections During COVID (Pink Sheet)
  • Insilico, Taisho form AI partnership to tackle age-related diseases and mortal cells (Fierce)
  • Gene Therapy Approval Standards: Available Treatments Influence US FDA’s View On Durability (Pink Sheet)
  • Gilead feels the heat as close ally Galapagos reports a big setback on one of their top experimental drugs (Endpoints)
  • After years of shortages, Merck announces plans for a new factory for an old lifesaving drug (Endpoints)
  • 3M spinoff Kindeva Drug Delivery plots new Minnesota operations center (Fierce)
  • Bayer Seeks Speedy EMA Review For Diabetic Kidney Disease Drug Finerenone (Pink Sheet)
  • Four biotechs and a Matthew Roden-led SPAC price IPOs, raising a combined $528M (Endpoints)
  • Ameet Nathwani rebounds from Sanofi purge to helm Dewpoint; Ali Mortazavi named CEO at e-therapeutics (Endpoints)
Medtech
  • Medtronic pits TAVR device against Edwards Sapien 3, eyes challenge to Abbott's MitraClip (MedtechDive)
  • Medtronic CEO pitches strategy revamp, but Wall Street takes wait-and-see approach (MedtechInsight)
  • What You Need to Know About Clinical Evidence For The EU IVDR (MedtechInsight)
  • Roche diagnostics Q3 sales spiked 18% as COVID-19 offset routine test drop (Reuters)
  • The Politics And The Practice Of UK Standalone Devices Regulation (MedtechInsight)
Government, Regulatory & Legal
  • Not just Obamacare: How Supreme Court's conservative majority could remake American health care (Politico)
  • US Merck Prevails In Vaccine IP Battle Against Pfizer (Law360)
  • Trump Admin. Sued For Withholding Virus Vaccine Contracts (Law360)
  • St. Jude Can't Revive Heart Valve IP Challenge At Fed. Circ. (Law360)
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.

Tags: US, worldwide

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