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.
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