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July 16, 2020
by Michael Mezher

Recon: J&J to begin coronavirus vaccine clinical trials; Novartis says it will offer ‘no profit’ generics for COVID-19 to 79 countries

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Johnson & Johnson Readies to Start Covid-19 Vaccine Studies (WSJ)
  • J&J earnings drop 35% as pandemic delays elective procedures (Financial Times)
  • Chief Vaccine Scientist Will Not Be Forced to Disclose Pharmaceutical Stocks (NYTimes)
  • Abbott Laboratories Gets Boost From US Covid-19 Testing (WSJ)
  • Congress Set to Tackle Vaccine Funding in Next Round of Coronavirus Aid (WSJ)
  • US must spend $75 billion to fix flawed Covid-19 testing, report says (STAT)
  • How a Struggling Company Won $1.6 Billion to Make a Coronavirus Vaccine (NYTimes)
  • House panel probes 'problematic' government contracts for COVID-19 supplies (The Hill)
  • Despite safety, efficacy concerns, FDA AdCom narrowly recommends Mallinckrodt drug (Endpoints)
  • Fatal overdoses climbed to record high in 2019, reversing historic progress (Politico)
In Focus: International
  • Novartis to provide 'no profit' COVID-19 drugs to low income countries (Reuters) (STAT)
  • UK, US and Canada allege Russian cyberattacks on Covid-19 research centers (CNN) (CNCB)
  • China gives the go-ahead for human trials of BioNTech's COVID vaccine candidate (Reuters)
  • Chinese executives get ‘pre-test’ injections in vaccine race (AP)
  • AstraZeneca Pressure Mounts as Investors Await Oxford Vaccine Data (Bloomberg)
  • China's Sinopharm begins late stage trial of COVID-19 vaccine in UAE (Reuters)
  • More than 150 countries engaged in COVID-19 vaccine global access facility (WHO)
  • Democratic Republic of the Congo Ebola cases rise, surpass previous outbreak (WHO)
  • Neglected tropical diseases of the skin: WHO launches mobile application to facilitate diagnosis (WHO)
Coronavirus Pandemic
  • Coronavirus Drug and Treatment Tracker (NYTimes)
  • Scientists raise questions over lasting immunity from Covid-19 vaccine (Financial Times)
  • Scientists call for volunteers to be infected with the coronavirus to test vaccines (CNBC)
  • Trump Is Donating Ventilators to Countries That Don’t Need or Can’t Use Them (ProPublica)
  • EU Politicians Call For Compulsory Licensing, More Joint Procurement For COVID-19 (Pink Sheet)
  • The founder of Adimab believes he can combat Covid-19 — and whatever pandemic comes next (STAT)
  • Once a relic of medical history, radiation emerges as an intriguing — and divisive — treatment for Covid-19 (STAT)
  • A startup launches with big plans to develop antibody drugs for coronaviruses (BioPharmaDive) (Endpoints)
  • UK government orders halt to Randox Covid-19 tests over safety issues (The Guardian)
  • Coronavirus (COVID-19) Update: Daily Roundup July 15, 2020 (FDA)
Pharma & Biotech
  • Deep Dive Into Big Pharma AI Productivity: One Study Shaking The Pharmaceutical Industry (Forbes)
  • The $1B Merck-Bayer drug that divided cardiologists in March gets priority review (Endpoints)
  • AZ unveils detailed data from THALES trial (PharmaTimes)
  • How The US FDA Finds Pre-Approval Inspection Alternatives During COVID-19 Pandemic (Pink Sheet)
  • Bionova aims to launch commercial manufacturing by 2021 with new biologics plant (Fierce)
  • Japan Govt to Push Ahead with Off-Year Survey, Considering COVID-19 Impact to Decide on Re-Pricing (PharmaJapan)
  • The pandemic has exposed our broken pharma supply chain. Synthetic biology and brewer’s yeast could fix it (STAT)
  • UK's MHRA allows early access to lumasiran for ultra-rare disease (PharmaTimes)
  • Orphan Exclusivity: Rarely Used, But Well-Known, Loophole Would Be Closed By House Legislation (Pink Sheet)
  • GSK’s Shingrix leader Guillaume Pfefer has jumped on board Flagship to helm a biotech hybrid as Afeyan’s latest CEO-partner (Endpoints)
  • Full Brilinta study results show the blood thinner reduces rate of secondary stroke (Endpoints)
  • A neurosurgeon spent the past 30 years developing a neoantigen tumor vaccine. Now he has $112M for a pivotal test (Endpoints)
  • BioAtla rakes in $72.5M Series D, advancing research for pH-detecting cancer treatments (Endpoints)
  • Relay reaps $400M IPO windfall after drawing the curtain on motion-based drug design pipeline (Endpoints)
  • Gilead's ex-R&D chief Bischofberger heads back to the biotech giant to pick up a pair of late-stage drugs that had been put aside (Endpoints)
  • New biotech Exalys, seeking to prevent postoperative delirium, launches with $15 million in Series A (Endpoints)
  • Newly discovered cell could help predict rheumatoid arthritis flare-ups (NBC)
Medtech
  • Medtronic to acquire Medicrea, maker of patient-specific, 3D-printed spine implants (Fierce)
  • Thermo Fisher boosts offer for Qiagen (MassDevice)
  • Smith & Nephew launches new hand-held robotic tool amid COVID-19 health sector pullback (MedtechDive)
  • UK signals Stryker offer to unload ankle replacement product could clear Wright Medical buy (MedtechDive)
  • ‘Months Of Activity’ Lost By Notified Bodies: New EU Measures May Be Needed (MedtechInsight)
Government & Regulatory
  • Directing advertising exclusively to health professionals (TGA)
  • Actual and potential harm caused by medical software: A rapid literature review of safety and performance issues (TGA)
  • A Practical example of applying Quality Risk Management in GDP – Transportation Risks (MHRA)
  • Looks Like A Slim, But Solid, First Amendment Majority (Drug & Device Law)
  • Seema Verma broke federal rules on her publicity contracts, inspector general finds (Politico)
  • Pfizer Must Face Claims It Didn't Monitor Chantix Risks (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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