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May 20, 2020
by Michael Mezher

Recon: Woodcock, Marks recuse themselves from COVID-19 vaccine approval decisions; FDA approves Lynparza for prostate cancer

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Amid conflict-of-interest criticisms, top FDA officials recuse themselves from Covid-19 vaccine approvals (STAT)
  • Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine (STAT)
  • Prototype Vaccines Protect Monkeys From Coronavirus (NYTimes) (Reuters)
  • Inovio says COVID-19 vaccine produces antibodies in mice, guinea pigs (Reuters)
  • Lonza CEO says on pace to make Moderna trial vaccine in June/July: CNBC (Reuters)
  • Amid Hydroxychloroquine Uproar, Real Studies of Drug Are Suffering (NYTimes) (NPR)
  • The Risks of Trump’s Hydroxychloroquine Hype (NYTimes)
  • CEO tapped by Trump to make generic drugs during pandemic has a dicey track record (STAT)
  • AstraZeneca-Merck's Lynparza gets FDA nod for prostate cancer treatment (Reuters) (Endpoints) (FDA)
In Focus: International
  • WHO chief says he will keep leading virus response after Trump threat (Reuters)
  • Fujifilm shares fall after report Avigan not showing clear efficacy in some coronavirus trials (Reuters)
  • China Leads The Worldwide Race To Develop A COVID-19 Vaccine (NPR)
  • Swiss seek to secure COVID-19 vaccine amid hoarding fears (Reuters)
  • Brazil widens use of malaria drugs to treat mild coronavirus cases (Reuters)
  • Thailand says it expects coronavirus vaccine next year after tests in mice (Reuters)
  • Coronavirus behaving differently in China's northeast clusters, expert says (Reuters)
  • Japan pharma: race to escape (Financial Times)
  • Raids Reveal Massive Fentanyl Production in Myanmar (NYTimes)
Coronavirus Pandemic
  • CDC quietly releases detailed guidelines for reopening America (CNBC)
  • 'We've been muzzled': CDC sources say White House putting politics ahead of science (CNN)
  • NIH to study how COVID-19 pandemic may have affected pregnancy outcomes in US (Reuters)
  • Coronavirus particles spread by talking can remain in the air for up to 14 minutes, NIH researchers find (CNBC)
  • Florida Dismisses A Scientist For Her Refusal To Manipulate State's Coronavirus Data (NPR)
  • MHLW Adds Veklury in Updated COVID-19 Treatment Guide (PharmaJapan)
  • Dutch farm worker contracted coronavirus from mink: agriculture minister (Reuters)
  • Argentine scientists working on low-cost two-hour coronavirus test (Reuters)
  • Bolivian city gives out free doses of de-worming drug in bid to combat coronavirus (Reuters)
  • Brazil suffers record coronavirus deaths, Trump mulls travel ban (Reuters)
Pharma & Biotech
  • Real-time data are essential for Covid-19. They’re just as important for the opioid overdose crisis (STAT)
  • Cash-strapped Clovis bums out investors with $85M offering (Fierce)
  • Biotech companies raise cash as coronavirus updates lift stocks (BioPharmaDive)
  • Two years of halting progress and high turnover preceded Atul Gawande’s exit as Haven CEO (STAT)
  • A little-known biotech running low on cash looks to get its own $100M IPO from pandemic market (Endpoints)
  • Ally Bridge joins Bain in $120M bet that speeding up manufacturing QC can hit big in post-pandemic world (Endpoints)
  • George Church spinoff swallows a key manufacturing partner as it preps CRISPR-edited pig organs for animal testing (Endpoints)
  • Flush with $165M IPO cash, Zentalis entices Tybourne, OrbiMed to fund a $20M China joint venture (Endpoints)
  • Pharmasset co-founder jumps into Covid-19 fight, with a new company and $215 million to get there (Endpoints)
  • Silence Therapeutics wants to list on Nasdaq while pursuing new deals; Surface Oncology inks latest Keytruda collaboration (Endpoints)
  • Samsung Bioepis Announces Four-Year Follow-Up Data for its Trastuzumab Biosimilar and 24-Week Interim Results from Phase 3 Trial of its Proposed Ranibizumab Biosimilar (Big Molecule Watch)
Medtech
  • South Korea adds renewal requirement for new medical device authorizations (Emergo)
  • Investors bet diabetes tech immune to full brunt of COVID-19 (MedtechDive)
  • AdvaMed, health systems set ground rules for return of sales reps (MedtechDive)
  • Thermedical’s Groundbreaking SERF Ablation System Earns FDA’s Breakthrough Device Designation (Press)
  • Baxter Receives CE Marking and Australian Regulatory Approval for Evo IQ Syringe Infusion System, Building on Smart Pump Platform (Press)
Government & Regulatory
  • Johnson & Johnson to End Talc-Based Baby Powder Sales in North America (NYTimes)
  • Broad, UC Each Tell PTAB It Invented CRISPR First (Law360)
  • J&J Unit Must Face Class Claims Over 'Rapid Release' Tylenol (Law360)
  • European Medicines Agency and EuropaBio – 26 May 2020 (EMA)
  • Australian Regulatory Guidelines for Listed Medicines and Registered Complementary Medicines (TGA)
  • Federal legislation to protect health data has made little progress. Will that change in the Covid-19 era? (STAT)
  • Effective field safety notices (FSNs): guidance for manufacturers of medical devices (MHRA)
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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