Regulatory Focus™ > News Articles > 2020 > 7 > Recon: Moderna launches Phase 3 COVID-19 vaccine testing; AstraZeneca, Daiichi sign $6B deal for tar

Recon: Moderna launches Phase 3 COVID-19 vaccine testing; AstraZeneca, Daiichi sign $6B deal for targeted cancer drug

Posted 27 July 2020 | By Michael Mezher 

Recon: Moderna launches Phase 3 COVID-19 vaccine testing; AstraZeneca, Daiichi sign $6B deal for targeted cancer drug

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Trump signs orders aimed at lowering drug prices in largely symbolic move (Washington Post) (STAT) (NYTimes) (Reuters)
  • Meadows says White House is 'hopeful' it can announce new coronavirus therapies 'in the coming days' (The Hill)
  • Gilead's second act in cell therapy gets its first approval (BioPharmaDive) (Endpoints) (FDA)
  • Moderna gets further $472 million U.S. award for coronavirus vaccine development (Reuters)
  • Moderna's COVID-19 vaccine candidate moves into late-stage trial (Reuters) (WSJ) (FT)
  • Indivior to pay $600 million to settle U.S. opioid treatment marketing claims (Reuters) (FT) (DOJ)
  • Emergent signs $174 million deal to make AstraZeneca's potential COVID-19 vaccine (Reuters)
  • Corporate Insiders Pocket $1 Billion in Rush for Coronavirus Vaccine (NYTimes)
  • FDA demands more data from Solid Bio to lift gene therapy hold (Fierce) (Endpoints)
  • U.S. Republicans to unveil coronavirus aid proposal as time runs out on jobless benefits (Reuters)
In Focus: International
  • Exclusive: EU talks with Pfizer, Sanofi, J&J on COVID vaccines hit snags – sources (Reuters)
  • AstraZeneca Strikes $6 Billion Cancer Drug Deal (WSJ) (Reuters) (Press)
  • Novartis, Austria team up to support Tyrol antibiotics plant (Reuters) (Press)
  • Diagnostics group Novacyt to launch more COVID-19 testing products (Reuters)
  • Biocad discussing potential COVID-19 vaccine production in China (Reuters)
  • India to boost drug and medical device production to lessen reliance on imports (Reuters)
  • World Hepatitis Day: fast-tracking the elimination of hepatitis B among mothers and children (WHO)
Coronavirus Pandemic
  • The World’s Supply Chain Isn’t Ready for a Covid-19 Vaccine (Bloomberg)
  • US ‘failures’ are holding back search for coronavirus drugs (The Guardian)
  • The Color of COVID: Will Vaccine Trials Reflect America’s Diversity? (KHN)
  • A Possible Weapon Against the Pandemic: Printing Human Tissue (NYTimes)
  • Covid-19 infections leave an impact on the heart, raising concerns about lasting damage (STAT)
  • Human clinical trials of COVID-19 vaccine 'Covaxin' begin at a hospital in Odisha (Economic Times)
  • Testing Results Take Too Long, U.S. Official Concedes (NYTimes)
  • FDA authorizes first COVID-19 test for screening people without symptoms (Fierce) (FDA)
  • Coronavirus (COVID-19) Update: Daily Roundup July 24, 2020 (FDA)
Pharma & Biotech
  • The top 20 drugs by global sales in 2019 (Fierce)
  • A Boy With Muscular Dystrophy Was Headed For A Wheelchair. Then Gene Therapy Arrived (NPR)
  • Can progenitor cells go further than gene therapy in retinal disorders? A biotech's answer shines in PhIIb (Endpoints)
  • Boehringer Ingelheim beefs up vet portfolio with GST buyout; Novartis, Austria to invest €150M in European manufacturing deal (Endpoints)
  • Billionaire Dietmar Hopp steers his secretive Covid-19 biotech player to Nasdaq following major pact with GSK (Endpoints)
  • TCR² releases early data from some PhI patients, sparking optimism from analysts (Endpoints)
  • Successful scientist-investor allies team up again — this time for a stab at rare metabolic disease (Endpoints)
  • Sobi To Appeal Against EMA Rejection For Emapalumab (Pink Sheet)
  • Israel's Zebra Medical gets FDA clearance for mammography tool (Reuters)
  • Abbott receives FDA approval for neurostimulator-controlling iPhone app for personalizing therapies for pain, Parkinson's disease (Fierce)
  • Want To Make Faster Class I Recall Decisions? Then Put Women In The Boardroom, Study Says (MedtechInsight)
  • Edwards aims for 5% TAVR sales growth in 2020 after seeing demand bounce back (MedtechDive)
  • Reshaping Medtech Regulations After A Health Care Emergency: What COVID-19 Could Mean For The UK (MedtechInsight)
Government & Regulatory
  • Regulatory considerations on the classification of non-medical masks or face coverings: Notice to industry (Health Canada)
  • Coronavirus Q&A: Sidley Austin's FDA Group Leader (Law360)
  • Generic group fails again to block California law that bans pay-to-delay deals (STAT) (Law360)
  • AbbVie Sues To Block Dr. Reddy's Generic Leukemia Drug (Law360)
  • Why A Surge In Drug Pricing Litigation Is Unlikely (Law360)
  • Judge Advises Freeing Amgen, Teva From Suits Over Sensipar (Law360)
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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