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Recon: Moderna’s coronavirus vaccine gets fast track designation; WHO sees 7 or 8 top vaccine candidates
Recon: Moderna’s coronavirus vaccine gets fast track designation; WHO sees 7 or 8 top vaccine candidates
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Moderna's potential coronavirus vaccine gains FDA's 'fast track' status (Reuters ) (STAT )
Novavax Jumps on $388 Million Funding From Vaccine Coalition (Bloomberg )
Fauci Says ‘Consequences Could Be Really Serious’ for Reopening Too Soon (NYTimes )
Hydroxychloroquine shows no benefit against coronavirus in NY study (Politico )
White House Orders Staff To Wear Face Masks After New Coronavirus Cases (NPR )
White House pushes states to test 2 percent of their populations for coronavirus (Politico )
Mail-Order Drug Delivery Rises During Coronavirus Lockdowns (WSJ )
Distribution of Key Drug Was Flawed, Says White House Official (WSJ )
With little data, doctors struggle to decide which Covid-19 patients should get remdesivir (STAT )
Merck to move global headquarters, returning to an old home (Endpoints ) (Fierce )
Sponsored Content: Clinical and regulatory challenges for cell and gene therapies
In Focus: International
WHO says 7 or 8 `top’ candidates for a COVID-19 vaccine exist (AP )
WHO sees 'potentially positive data' on COVID-19 treatments (Reuters )
EU signs contract with Philips on ventilators (Reuters )
Japan to approve first coronavirus antigen test kits on Wednesday (Reuters )
Mylan CEO says its global supply chain helped it experience ‘minimal disruption’ during pandemic (CNCB )
WHO says 'extreme vigilance' needed in exit from lockdowns (Reuters )
Nations ‘Sober Up’ and Start to Withdraw Medical-Export Bans (Bloomberg Law )
French drug maker Genfit says NASH drug fails late-stage clinical trial (STAT ) (Endpoints )
Japan COVID-19 Vaccine Trial Could Begin as Early as July: Abe (PharmaJapan )
Zolgensma to Get Japan’s Highest List Price ¥167M Yen, but Peak Sales Put at Just ¥4B (PharmaJapan )
Coronavirus Pandemic
A strategic approach to COVID-19 vaccine R&D (Science )
As States Rush to Reopen, Scientists Fear a Coronavirus Comeback (NYTimes )
Coronavirus cases are on the rise in Texas and other states that reopened early, former FDA chief says (CNBC )
Mass coronavirus testing plans unrealistic, warns Italian biotech boss (Financial Times )
Enzyme makes men more vulnerable to coronavirus; adding interferon may improve treatment (Reuters )
COVID umbrella trials multiply (Nature )
What’s Up With Ivermectin? (In The Pipeline )
Factories In Syria Ramp Up Production Of Hydroxychloroquine Amid Soaring Demand (NPR )
Govt Officials Urge Japan Pharma Companies to Be More Proactive in Coronavirus Vaccine Development (PharmaJapan )
Post-market evaluation of serology-based point of care tests (TGA )
China's Wuhan plans city-wide testing for coronavirus over period of 10 days: sources (Reuters )
Japan sees 20% fall in number of hospitalised COVID-19 patients in 9 days (Reuters )
U.S. coronavirus death toll tops 80,000 - Reuters tally (Reuters )
UK's COVID-19 death toll tops 38,000, worst in Europe (Reuters )
UK needs to boost 'trustworthiness' of COVID-19 test target, regulator warns (Reuters )
Pharma & Biotech
A secret experiment revealed: In a medical first, doctors treat Parkinson’s with a novel brain cell transplant (STAT )
Prominent Broad Institute scientist leaves to lead R&D at Genentech (STAT )
Novartis-backed Gamida hits goal in phase 3 cancer trial (Fierce ) (Endpoints )
Sanofi takes aim at J&J's myeloma star Darzalex with latest Sarclisa trial win (Fierce ) (Press )
AryoGen’s bevacizumab biosimilar BE1040V found noninferior to AVASTIN in phase III study (Big Molecule Watch )
Merck doubles down on Skyhawk's tech to drug RNA, promising $600M per autoimmune, metabolic target (Endpoints )
Chinese biotech aims $232M in IPO cash to push next-gen prostate cancer drug; Immunomedics raises nearly a half-billion off approval (Endpoints )
Ex-DARPA chief Regina Dugan, former Illumina CEO Jay Flatley lead $300M Wellcome Trust fund to tackle global health's Sputnik moment (Endpoints )
Vivek Ramaswamy’s brother, Shankar, spins out on his own, launching audacious gene therapy play (Endpoints )
With money flowing, Pliant Therapeutics heads to public well (Endpoints )
MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug (FDA )
Medtech
European Commission's Device Standardization Request Imminent (MedtechInsight )
Zimmer posts $509M loss in Q1 as 80% of business faces COVID-19 hit (MedtechDive )
BD stops selling COVID-19 antibody test it touted in March (MassDevice )
CardioFocus wins FDA approval for HeartLight X3 endoscopic ablation system (MassDevice )
Endologix shares fall on missed Q1 projections (MassDevice )
Conformis slides on missed Q1 projections (MassDevice )
Government & Regulatory
Advertising pharmacist-only (Schedule 3) medicines (TGA )
Work plan 2020 of the Good Clinical Practice Inspectors’ Working Group (EMA )
J&J Must Face Revived Risperdal Labeling Claims In Calif. (Law360 )
6th Circ. Opioid Opinion On Federal Rules Helps Cos. In MDLs (Law360 )
Theranos Offers Defense Lessons For Multi-Agency Probes (Law360 )
Illumina Nears Win In Bid To Block BGI's DNA Product Sales (Law360 )
Eagle Pharmaceuticals Inc. v. Slayback Pharma LLC (Fed. Cir. 2020) (Patent Docs )
Plaintiffs’ Beast of Burden: Adverse Event Reports Precede Causation (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.