AstraZeneca confirms Russia vaccine deal days after COVID-19 hacking accusations surface (Fierce)
Biocon annouces digital diabetes tie-up with Voluntis (PharmaPhorum)
Amplitude raises $50M to fuel ‘emerging’ Canadian biotech field (Endpoints)
EFPIA Rejects EU Calls To Relax IP Protections (Pink Sheet)
How The European Medicines Agency Inspected Thermo Fisher’s Florida Plant Without Leaving Europe (Pink Sheet)
Coronavirus Pandemic
Vaccine trials show early promising results — but major challenges are ahead (NBC)
Growing Body Of Evidence Suggests Masks Protect Those Wearing Them, Too (NPR)
China Uses WHO Inquiry to Tout Coronavirus Response (NYTimes)
Public health group calls for standardized data collection to more clearly track Covid-19 (STAT)
HHS unveils new coronavirus hospitalization database, says it’s more complete than CDC’s (CNBC)
Actual Covid-19 case count could be 6 to 24 times higher than official estimates, CDC study shows (STAT)
Chronic fatigue syndrome may hold keys to understanding post-Covid syndrome (STAT)
AstraZeneca Aims to Deliver100 Million Doses of Coronavirus Vaccine to Japan: CEO (PharmaJapan)
Connecticut discovers at least 90 false positive coronavirus tests (The Hill)
Mesoblast, Athersys Take Lead In Race To Develop Stem Cell Therapies For COVID-19 (Pink Sheet)
Coronavirus (COVID-19) Update: Daily Roundup July 20, 2020 (FDA)
Pharma & Biotech
Cancer startup aims precision medicine at rare genetic driver (STAT)
Researchers Hope Experimental Gene Therapy Is An Answer To A Fatal Genetic Disorder (NPR)
UK Allows Early Access To Alnylam’s Lumasiran For Ultra-Rare Disorder (Pink Sheet)
Japan Approves MSD’s 9-Valent HPV Vaccine 5 Years after Filing (PharmaJapan)
September Drug Price Survey Likely as MHLW to Keep Its Proposal Unchanged (PharmaJapan)
AbbVie's Rinvoq backs up eczema case with 2nd pivotal trial win (Fierce) (Press)
Daiichi Sankyo Announces Phase 3 Study Results for Prasugrel Antiplatelet Agent in Thrombotic Stroke Patients (Press)
Bayer plays the long game with plans to double workforce at Berkeley biologics site (Fierce)
PBM-Owned Specialty Pharmacies Expand Their Role In—and Profits From—the 340B Program (Drug Channels)
The Importance of Countering Biosimilar Disparagement and Misinformation (BioDrugs)
Elevation Oncology launches with $32.5 million Series A, gives new life to former Merrimack program (Endpoints)
Novartis quietly buries another failed eczema drug, with a $485M hit embedded in the footnotes (Endpoints)
Leo Pharma offloads a psoriasis asset as their Dupixent rival heads to the FDA (Endpoints)
Pieris slammed with FDA hold; Biogen adds PhIV for Spinraza (Endpoints)
Roche partners on a slate of Jnana's immunology, neurology targets, rewarding its faith in the SLC transporter class (Endpoints)
Juno/WuXi's cell therapy venture buys out solid tumor player in China, gaining a discovery engine and portending more M&A to come (Endpoints)
Chris Garabedian's incubator leads Series A funding for gene therapy manufacturer/developer combo (Endpoints)
Medtech
Commission To Submit Yet Another European Standards Request – In Early 2021 (MedtechInsight)
NuVasive surprises analysts with sooner-than-expected spine surgery sales rebound (MedtechDive)
India may start exporting ventilators: Commerce and industry minister Piyush Goyal (Economic Times)
Quidel says its COVID-19 antigen test is now on par with PCR accuracy (MedtechDive)
LifeSignals wireless biosensor wins FDA clearance (MassDevice)
Paige pathology viewer lands FDA clearance (MassDevice)
Government & Regulatory
Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2019 to 2020 (MHRA)
One Country, Two Regulatory Systems: Another Brexit Headache (Pink Sheet)
Elizabeth Holmes trial likely delayed until 2021 because of Covid-19 (CNBC)
FDA’s Continued Commitment to the Safety and Security of Our Laboratories (FDA)
New Funding Opportunity: FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program (FDA)
Roerig Division of Pfizer Inc., et.al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications (FDA)
Submissions received: Products used for and by people with disabilities (TGA)
UK Reopens Pharma Probes After COVID-19 Delays (Law360)
CVS, Walgreens Want Out Of Blood Pressure Drug MDL (Law360)
Opioid Judge 'Concerned' About Amerisource Hiding Docs (Law360)
Blood Testing Device Co. Notches Win In Rival's False Ad Suit (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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