Recon: Pfizer-US COVID vax deal details emerge; EC OKs Sanofi's aspart biosimilar
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- US Price for Pfizer COVID Vaccine Includes Company Distribution Efforts Directed By DOD, CDC (Pink Sheet)
- J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about? (Endpoints)
- Three More Experimental Therapies Receive Rare Pediatric Disease Designation by FDA (Global Genes)
- Kymera Therapeutics, fresh off a $2B Sanofi biobucks pact, guns for an IPO (Fierce Biotech)
- Stryker Beats Consensus but Still Feels COVID-19 Sting (MD+DI)
- Trump and Big Pharma tussle over drug price proposal with 3 months until election (Fierce Pharma)
- The day the music died? FDA fields request to ban background music in DTC ads (Fierce Pharma)
- The drug industry’s new tactic in Washington: calling Trump’s bluff (STAT)
In Focus: International
- Sanofi faces manslaughter charges in France over years-long Depakine probe (Fierce Pharma)
- Indian Billionaires Bet Big on Head Start in Coronavirus Vaccine Race (NYT)
- EC approval for Sanofi’s insulin aspart biosimilar (GaBi)
- Rozlytrek, Roche’s first tumour-agnostic therapy, approved in Europe for NTRK fusion-positive solid tumours and for ROS1-positive advanced NSCLC (Roche)
- Sanofi and GSK say they're near a vaccine deal with EU hours after finalizing Warp Speed contract (Endpoints)
Coronavirus Pandemic
- U.S. Sees Smallest Number Of Daily New Covid-19 Cases In Week (Forbes) (The Hill)
- Birx Warns U.S. Coronavirus Epidemic Is In 'New Phase' As Cases And Deaths Climb (NPR) (NYT)
- Calidi Biotherapeutics Announces FDA Approval for COVID-19 Treatment Manufactured by Partner: Personalized Stem Cells (Businesswire)
- Lilly begins nursing home trials with antibody drug for COVID-19 prevention (NBC News) (Fierce Biotech) (Endpoints)
- Rival drugmakers launch joint trial of medicines for COVID-19 (Reuters)
- AbCellera kicks off Phase 3 COVID-19 therapeutics clinical trials, expands COVID-19 antibody database (Businesswire)
- Who's first in line for a COVID-19 vaccine? The debate begins (NBC News)
- UK to roll out COVID-19 diagnostic that provides results in under two hours (EPR)
- Russia gears up for mass vaccination against coronavirus despite international skepticism (CNBC)
- Nation’s testing czar: It’s ‘time to move on’ from talk about hydroxychloroquine (CNBC)
- BCG shots could slow down Covid-19 spread in first thirty days, says study (Economic Times)
- Anxious WHO implores world to 'do it all' in long war on COVID-19 (Reuters)
Pharma & Biotech
- The secret life of excipients (Nature Reviews)
- Music in drug ads makes it easier for the public to tune out side effects, advocates argue (STAT)
- CAR T cell therapy is revolutionising cancer treatment, but at what cost? (Pharmafile)
Medtech
- Could Technology Advance the Future of Endoscopic Procedures? (MD+DI)
- Varian sold to Siemens Healthineers in $16.4B all-cash deal (MedtechDive)
- J&J gets FDA breakthrough status for robot-assisted ablation device (MedTechDive)
- Exact Sciences bets pandemic will accelerate adoption of Cologuard (MedTechDive)
- Brain Navi develops new robot that performs nasal swab tests autonomously (mobihealthnews)
Government & Regulatory
- House panel finds Trump admin bungled Philips ventilator deal, overpaid by $500M (MedtechDive)
- Scientists Worry About Political Influence Over Coronavirus Vaccine Project (NYT)
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.