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May 28, 2020
by Michael Mezher

Recon: FDA finds NDMA in some metformin products; EU plans permanent medical stockpile

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • “I’ll Send You the Contact”: Documents Expose FDA Commissioner’s Personal Interventions on Behalf of Trump’s Favorite Chloroquine Doctor (Vanity Fair)
  • US coronavirus deaths top 100,000 as country reopens (Reuters)
  • FDA Finds Carcinogen in Some Versions of Metformin (Bloomberg) (Reuters) (STAT)
  • Pfizer ties up with glass maker Corning for vial supply (Reuters)
  • Big gene therapy names line up behind experimental Covid-19 vaccine (STAT) (Endpoints)
  • Moderna extends lipids deal to boost COVID-19 vaccine candidate output (Reuters)
  • Roche mixes Actemra with Gilead's remdesivir in COVID-19 trial (Reuters) (Bloomberg) (Press)
  • Gilead study shows shorter five-day course of remdesivir works as well as 10-day one (Reuters)
  • Merck adopts ‘error catastrophe’ coronavirus drug (Financial Times)
  • Coronavirus Continues to Disrupt Prescription Drug Supplies (NYTimes)
  • Medical societies have ‘extensive’ financial ties with drug and device makers (STAT)
In Focus: International
  • EU plans permanent stockpile of essential drugs, medical gear (Reuters)
  • WHO creates foundation to boost funding in coronavirus fight (Reuters) (WHO)
  • AstraZeneca partners with Oxford Biomedica to expand COVID-19 vaccine manufacturing capacity (Reuters)
  • AstraZeneca says it may consider exposing vaccine trial participants to virus (Reuters)
  • AstraZeneca tests diabetes drug for COVID-19 despite risk seen by doctors (Reuters)
  • GSK aims for one billion doses of booster as COVID-19 vaccine race heats up (Reuters)
  • Indonesia to keep prescribing two malaria drugs for COVID-19 despite bans in Europe (Reuters)
  • British regulator says 'COPCOV' hydroxychloroquine trial paused (Reuters)
  • India allows export of paracetamol API: statement (Reuters)
  • WHO Prequalifies Celltrion’s Rituximab (Pink Sheet)
  • BDR Pharmaceuticals move on Remdesivir clone irks Gilead (Economic Times)
Coronavirus Pandemic
  • Bad state data hides coronavirus threat as Trump pushes reopening (Politico)
  • NIH director: ‘No way of knowing’ if coronavirus escaped from Wuhan lab (Politico)
  • Coronavirus Epidemics Began Later Than Believed, Study Concludes (NYTimes)
  • Remdesivir — An Important First Step (NEJM)
  • Drugs Authorized for Coronavirus? Why There’s Skepticism (Washington Post)
  • No preferential access to Themis' potential COVID-19 vaccine: CEO (Reuters)
  • Pence Chief Of Staff Owns Stocks That Could Conflict With Coronavirus Response (NPR)
  • Blood markers discovered for COVID-linked syndrome in children (NBC)
  • Antibody Tests Were Hailed As Way To End Lockdowns. Instead, They Cause Confusion. (KHN)
  • FDA offers reference panel to validate coronavirus tests amid false negative concerns (MedtechDive)
  • CDC seeks to limit false positives with COVID-19 antibody testing, as immunity question lingers (MedtechDive)
  • PureTech eyes clinical trial in long-term COVID-19 complications (Fierce)
  • Los Angeles Authorities Sue A Company For Coronavirus-Related Fraud (NPR)
  • Coronavirus (COVID-19) Update: Daily Roundup May 27, 2020 (FDA)
Pharma & Biotech
  • LabCorp ties up with software provider to expand virtual clinical trials (Reuters)
  • Medical Groups Ask FDA To Ease Access To Abortion Pill During The Pandemic (NPR)
  • A CRISPR Vision for the Future of Cell Therapy (GEN)
  • Stymied by the pandemic, Immunomedics' new CEO bows out, taking a million bucks plus perks as he heads out the virtual exit (Endpoints)
  • US relaxes rules for opioid substitutes during lockdowns (Financial Times)
  • Protalix files BLA to compete with Sanofi Genzyme; Rallybio collects another Alexion alum (Endpoints)
  • Global Supply Chain In Historic Upheaval As 'De-China' Trend Marches On (Pink Sheet)
  • Virtual US FDA Advisory Committees May Have One Silver Lining: Available Experts (Pink Sheet)
  • Presence Of Patient Experience Data Table In FDA Drug Review Summaries ‘Inconsistent’ (Pink Sheet)
  • Capitalizing Pablo: The world’s biggest drug royalty buyer is going public. And the low-key CEO divulges a few secrets along the way (Endpoints)
  • Denali unveils new way of crossing blood brain barrier as the big neuroscience bet enters its clinical years (Endpoints)
  • Drug developer, Big Pharma commercial exec, now an upstart biotech chief — Fabrice Chouraqui is ready to try something new as a ‘CEO-partner’ at Flagship (Endpoints)
  • Thermo Fisher continues global expansion push with CSL Behring biologics plant lease (Fierce)
  • Controlling Your Destiny: Why Investment in Manufacturing Capabilities Makes Sense (LifeSciVC)
Medtech
  • Biotronik touts results of CRT-DX study (MassDevice)
  • Analysts saw 30% drop in TAVR growth in April, but Q2 may be better than feared (MedtechDive)
  • Stryker announces $2.3b offering to finance Wright Medical purchase (MassDevice)
  • Texas-based team seeks EUA for 3D printed emergency ventilator (MassDevice)
  • Emergency authorization granted to COVID-19 ICU prediction software (MassDevice)
Government & Regulatory
  • Taiwan Antitrust Agency Clears Mylan, Pfizer Unit Deal (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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