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June 11, 2020
by Michael Mezher

Recon: States name 26 generic drugmakers in price fixing suit; Novo to buy Corvidia for up to $2.1B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • States Sue Drug Companies, Executives Over Alleged Price Fixing (WSJ) (Reuters) (STAT)
  • AstraZeneca ties up with Emergent BioSolutions to make COVID-19 vaccine in US (Reuters)
  • Lilly COVID-19 treatment could be authorized for use as soon as September: chief scientist (Reuters)
  • Regeneron begins human testing of COVID-19 antibody cocktail (Reuters) (WSJ)
  • Pfizer says it won't put "huge price" on coronavirus vaccine (Axios)
  • New York charges Endo with insurance fraud over opioid claims (Reuters)
  • NIH launches study to assess drugs for coronavirus-affected children in US (Reuters)
  • Quarantine fatigue: Governors reject new lockdowns as virus cases spike (Politico)
  • U.S. coronavirus cases now over 2 million (Reuters)
  • New report underscores the recent roller coaster of the biotech market (STAT)
  • Trump’s decision to leave WHO came with bluster, but no action so far (STAT)
In Focus: International
  • Novo Nordisk to Buy Corvidia for as Much as $2.1 Billion (Bloomberg) (Endpoints) (Press)
  • EU plans advance purchase of up to six promising COVID-19 vaccines: sources (Reuters)
  • Europe sets sights on dud antibody tests amid COVID-19 free-for-all (Reuters)
  • China offering coronavirus candidate vaccines to state workers, Global Times says (Reuters)
  • Outbreak quashed, China launches test lab spending spree (Reuters)
  • Japan's Takeda to sell some Asia-focused drugs to Celltrion for $278 million (Reuters) (Endpoints)
  • Only French victims of faulty breast implant may claim damages, EU court says (Reuters)
  • Russia rolls out first approved COVID-19 drug as infections pass 500,000 (Reuters)
  • WHO warns of 'accelerating' pandemic in Africa (Politico) (Reuters) (WHO)
  • WHO hopes to work with U.S. on Ebola despite Trump criticism (Reuters)
Coronavirus Pandemic
  • The Big-Data Mystery Behind Retracted Covid-19 Studies of Hydroxychloroquine, Other Drugs (WSJ)
  • IMF says $10 trillion spent to combat pandemic, far more needed (Reuters)
  • Seattle’s coronavirus surveillance program resumes after being shut down by the FDA (Seattle Times)
  • Pfizer partner BioNTech scores €100M debt financing to fund COVID-19 vaccine production in Europe (Fierce)
  • India lifts export ban on Trump-touted drug hydroxychloroquine (Reuters)
  • South Korean doctors find risk factors for severe COVID-19 cases (Reuters)
  • Researchers Are Looking Into Alternatives To Remdesivir In The Coronavirus Treatment (NPR)
Pharma & Biotech
  • Lonza partners with Anthos Therapeutics for thrombosis treatment (Reuters)
  • Pharma's May TV ad spend dips as marketers find new normal (Fierce)
  • Lilly starts large-scale trial of tirzepatide in diabetic heart disease (PMLive)
  • Two preclinical biotechs riding the IPO wave this week look to raise $466M-plus; Blackstone's Galakatos backs Reata to the tune of $350M (Endpoints)
  • A patient’s microbiome could have a major impact on how drugs affect them, new research confirms (STAT)
  • Verve, raising another $63 million, seeks to advance gene-editing treatment for heart disease (STAT) (Endpoints)
  • Juno, WuXi JV in China score $100M in fresh funding as it sets stage for first CAR-T approval (Endpoints)
  • A storied Chinese pharma partner of Bristol Myers, Amgen — and avid biotech supporter — plots HK IPO (Endpoints)
  • Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19 (FDA)
  • FDA data shows numerous drugs in shortage, including a leading antidepressant (USA Today)
  • The Vaccines for Children Program at 25 — Access, Affordability, and Sustainability (NEJM)
  • Phase 3 Trial of RNAi Therapeutic Givosiran for Acute Intermittent Porphyria (NEJM, Commentary)
  • Bone Drugs May Have Added Benefit: Lower Pneumonia Risk (NYTimes)
  • Perelman’s Discount Drug Company Said to Weigh Sale Interest (Bloomberg)
Medtech
  • MedTech Europe pitches virtual audits to clear MDR coronavirus logjam (MedtechDive)
  • EU MDR Standards Delay: MedTech Europe Offers A Pragmatic Way Forward (MedtechInsight)
  • Denmark’s Møller Named Executive Board Chair At Medical Device Competent Authorities Group (MedtechInsight)
  • Short-term ventilator sharing may be viable for COVID-19 patients: study (Reuters)
  • COVID-19 testing costs may hit $25B per year, AHIP study finds (MedtechDive)
  • Philips launches Lumify tele-ultrasound system in Japan (MassDevice)
Government & Regulatory
  • California supports an attorney’s unusual whistleblower lawsuit against ‘fraudulent’ patents (STAT)
  • COVID-19 Vaccine Developers Can Limit Liability From Trials (Law360)
  • Tuesdays (and Thursdays) With Regulations.gov BETA (FDA Law Blog)
  • A Loss, But Not Much of One (Drug & Device Law)
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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