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May 12, 2020
by Michael Mezher

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.
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