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Recon: 2021's priciest drugs; A leaderless FDA?

Posted 09 March 2021 | By Kari Oakes 

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)
  • 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.


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