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.
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