Recon: 2021's priciest drugs; A leaderless FDA?
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Novartis' canakinumab failed to improve survival in Phase III trial (Reuters ) (Endpoints )
Is a leaderless FDA clamping down on drug reviews? Not knowing is weighing heavy on biotech (STAT )
Pandemic Forces FDA to Sharply Curtail Drug Company Inspections (NYT )
A Survey of Survival Outcomes for Targeted Cancer Drugs Approved by the US Food and Drug Administration (PubMed )
Fauci, other Biden health officials to testify on vaccination effort (The Hill )
Biden Cancels Visit to Vaccine Maker After Times Report on Its Tactics (NYT )
Health official ousted by Trump to lead private coronavirus tracking effort (Science )
Avoiding a ‘gender recession’: New report details how the pandemic has impeded women’s STEMM careers (STAT )
In Focus: International
Japan's Terumo says makes syringe to draw seven doses from Pfizer vaccine vials (Reuters )
Swiss biopharma company to produce Russian Sputnik vaccine in Italy (The Hill )
Why Scientists Are Infecting Healthy Volunteers With The Coronavirus (NPR )
Russia's Sputnik V nabs first Twitter-verified vaccine handle, but is it PR or propaganda? (Fierce Pharma )
NICE rejects AZ’s Lynparza for metastatic prostate cancer (PharmaTimes )
Opinion: DTAC - Not left to our own devices (Healthcare IT News )
Coronavirus Pandemic
Mexico to buy 22 million more doses of Chinese coronavirus vaccines (Reuters )
Indonesia approves AstraZeneca vaccine for emergency use (Reuters )
Exclusive: J&J 'under stress' to meet EU second-quarter vaccine supply goal - source (Reuters )
Slow pace of vaccine delivery risks global COVID-19 recovery (The Hill ) (BioPharma Reporter )
Ukraine approves China's Sinovac COVID-19 vaccine (Reuters )
Russia's Sputnik V could be made in European Union after reported deals (Reuters )
Developers of Russian Sputnik V vaccine doubt EU regulator's neutrality, want apology (Reuters )
COVID-19 vaccine batch Austria has halted use of went to 17 countries (Reuters )
Pfizer, BioNTech vaccine tackles 3 troubling COVID-19 variants in lab study (Fierce Pharma )
Pharma & Biotech
Samantha Truex's Quench Bio calls it quits after failing to solve the Gasdermin D inflammation puzzle (Endpoints )
Acadia's surprise Nuplazid snag—and subsequent cold shoulder at FDA—beg more questions than answers (Fierce Pharma )
Ultrarare disease specialists top 2021's pricey drugs list, but Takeda, Merck KGaA meds rank, too (Fierce Pharma )
Koch's 'disruptive' VC bets $110M on one of Flagship's new, big computational startups (Endpoints )
Ready to exit 'quiet mode,' joint entity Ventyx debuts its immune modulator pipeline with $114M round (Endpoints )
No more squinting at menus? Visus Therapeutics nabs $36M for presbyopia-correcting eye drop (Endpoints )
Analysts picked the top 4 blockbuster contenders in the mix — and #1 is a $3.8B coin toss (Endpoints )
With data on a cancer drug derived from red blood cells looming, Rubius Therapeutics seeks to shed its bumbling image (Endpoints )
Gilead’s Investigational Lenacapavir Demonstrates Sustained Long-Acting Efficacy Through Week 26 in Data Presented at CROI (BusinessWire )
CBD reduces plaque, improves cognition in model of familial Alzheimer's (EurekAlert )
Charcot-Marie Tooth disease: A 100% French RNA-based therapeutic innovation (EurekAlert )
Taking a page from Celgene, Takeda builds and buys a cancer biotech (BioPharma Dive )
Lilly partners with Biolojic Design to develop diabetes antibody therapies (PMLive )
Medtech
Can chips replace animal testing? (EurekAlert )
Abbott updates app-based neuromodulation platform with remote programming (MobiHealthNews )
European ecosystem for health tech launched by Sanofi, Capgemini, Generali and Orange (MobiHealthNews )
Government & Regulatory
Novartis sues FDA over its stance on Sanofi blockbuster’s exclusivity (Endpoints )
Tax Breaks Will Offset $26 Billion Opioid Settlement, Drug Firms Say (NPR )
Regulatory updates are needed to prevent commercialization of islet transplantation in the US (PubMed )
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.