Brazil greenlights human trials for J&J's potential COVID-19 vaccine (Reuters)
Novo Nordisk taps Evotec to target chronic kidney disease (Fierce)
Coronavirus Pandemic
Vanda's experimental COVID-19 drug shows promise in interim trial data (Reuters)
Indian vaccine maker looks to raise $1B for COVID-19 shot manufacturing, trial efforts: report (Fierce) (Economic Times)
FDA warns of false coronavirus test results from Thermo Fisher kit (Fox Business) (FDA)
Quest Diagnostics says it cut coronavirus testing turnaround to one to two days, but warns it could slip (CNBC)
More Evidence Heartburn Drug May Help COVID-19 Patients (Medpage)
Coming COVID-19 vaccination wave will generate $20B in sales next year: analyst (Fierce)
Moderna stands to earn $300M for quick vaccine approval, up to $6.6B for extra doses: filing (Fierce)
US FDA COVID-19 Adcom: What Additional Members Are Needed? (Pink Sheet)
Collaboration with the Public Health Agency of Canada’s National Microbiology Lab (Health Canada)
Coronavirus (COVID-19) Update: Daily Roundup August 17, 2020 (FDA)
Pharma & Biotech
Even in the coronavirus era, US pharma and biotech employees say jobs secure: survey (Fierce)
Adding Sickle Cell Disease To FDA’s Priority Review Voucher List Of Neglected Tropical Diseases (Forbes)
AZ scores FDA priority review for new Imfinzi fixed-dose regimen (PMLive)
Real-World Evidence: Epizyme’s Epithelioid Sarcoma Natural History Study Falls Flat At US FDA (Pink Sheet)
USP Building Risk Model To Assess Supply Chain Vulnerabilities And Anticipate Drug Shortages (Pink Sheet)
China approves its first biosimilar of Roche's Herceptin in HER2+ cancers (Pharmafile)
STAT China: A debut for CanSino Biologics and Cellular BioMed’s controversy (STAT)
Trump campaign’s Facebook ad blitz casts Biden as pharma’s preferred candidate (STAT)
Opioid prescriptions written for Medicare Part D beneficiaries continues to drop (STAT)
AstraZeneca is changing up dosing regimens of its checkpoint player in the face of the pandemic. The FDA appears ready to make a quick assist (Endpoints)
Daniel O’Day’s I/O dance continues, as Gilead and Tango expand deal up to $6B (Endpoints)
Eli Lilly is betting $1B-plus that it can make yet another PD-1 drug a hit in the US. How about a deep discount this time? (Endpoints)
An MD Anderson study points to another use for Novartis’ GSK-born cancer drugs (Endpoints)
Chinook raises $106M in private placement as it prepares to close merger with Aduro (Endpoints)
Looking to expand beyond diabetes, Novo Nordisk enlists Evotec in CKD pact worth up to $179M per program (Endpoints)
Bayer’s estradiol/norethisterone injection in pre-filled syringes prequalified (WHO)
New restrictions introduced on sales of stimulant laxatives to counter risks from overuse (MHRA)
Medtech
FDA clears new version of Hyperfine's portable MRI scanner-on-wheels (Fierce)
Medtronic Invests $1.6Bn To Create Largest R&D Center Outside US (MedtechInsight)
Facing diabetes rivals in pumps and CGMs, Companion offers Medtronic a leg up in lagging pen market (MedtechDive)
Government, Regulatory & Legal
DC Circ. Won't Revisit Eagle's Orphan Drug Win Against FDA (Law360)
Allergan Wins Bid To ID Breast Implant Patients In MDL (Law360)
Pfizer Japan Takes Generic Contenders to Court over Lyrica Patent (PharmaJapan)
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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