Recon: J&J plans to enroll 60,000 in Phase 3 COVID vaccine trial; Otsuka cleared to buy Proteus’ assets

• For Covid-19 Vaccine, J&J Plans 60,000-Subject Pivotal Trial (WSJ)
• Trump suggests government scientists held back plasma therapy for political reasons (Politico)
• Pfizer and BioNTech’s favored Covid-19 vaccine has fewer side effects than their first (STAT)
• VA problems raise worries about mail slowdown, prescriptions (The Hill)
• Regeneron flashes ‘great advance' in the NEJM for that other cholesterol drug sitting at the FDA (Endpoints)
• How Feds Decide On Remdesivir Shipments To States Remains Mysterious (NPR)
• FDA authorizes its 3rd coronavirus antigen test to help meet high demand (Fierce)
• Otsuka approved to buy bankrupt smart-pill maker Proteus’ assets, overcoming opposition from Novartis (STAT)

• EU, CureVac in advanced talks for 225 million COVID-19 vaccine doses (Reuters)
• Russia to begin COVID-19 vaccine trials on 40,000 people next week (Reuters) (CNBC)
• Peru to test China Sinopharm's COVID-19 vaccine in Phase 3 trial (Reuters)
• Foreign Drug Giants Undercut by Up to 95% in China Bidding (Bloomberg) (Fierce)
• NICE recommends Roche’s Polivy for B-cell lymphoma (PMLive)

• Ramped-up testing and daily briefings: Inside Biden’s plan to take over a tumultuous Covid-19 response (STAT)
• This Trawler’s Haul: Evidence That Antibodies Block the Coronavirus (NYTimes)
• NIH Presses U.S. Nonprofit for Information on Wuhan Virology Lab (WSJ)
• Why is the ‘anti-vaxxer’ movement growing during a worldwide pandemic? (FT)
• FDA approves University of Illinois’ COVID-19 saliva test (Chicago Tribune)
• Coronavirus (COVID-19) Update: Daily Roundup August 19, 2020 (FDA)

• Two more biotechs leverage upsized offerings in IPO boom as Harbour pitches a raise in Hong Kong (Endpoints)
• Bristol Myers joins the lab rush in Cambridge with plans to consolidate R&D ops in a biotech campus now under construction (Endpoints)
• Geriatric Exclusivity? Incentives For Research In Elderly Debated At National Academies Workshop (Pink Sheet)
• Alzheon returns, with a $47 million NIH grant and one last shot at a pivotal PhIII Alzheimer’s success (Endpoints)
• Ron Evans steals a trick from I/O, and points the way to a transformational diabetes therapy (Endpoints)
• Watch out Bristol Myers, Merck is right on your heels with more positive Keytruda data to take to the FDA (Endpoints) (Press)
• Seven PD-(L)1 players could be vying for a place on China's drug reimbursement list. How far will they go? (Endpoints)
• Eli Lilly partner AbCellera acquires bispecific platform; Teva faces more lawsuits, this time over opioid marketing (Endpoints)

• FDA Shares Best Tips To Alleviate Premarket Submission Pain Points (MedtechInsight)
• Resterilizable Medical Device Shortfalls Lead To Simplified Guidance (MedtechInsight)
• Govt Survey Of UK HealthTech SMEs Shows Ongoing Failure To Prepare For EU MDR (MedtechInsight)

• Supreme Court to hear ObamaCare arguments one week after November election (The Hill)
• Actavis Inks Settlement In ADHD Drug Antitrust Suit (Law360)
• McKesson Gets FCA Suit Over Opioids Tossed, For Now (Law360)
• On Appeal, Justice Dept. Prevails in Bid to Dismiss Pharma Fraud Case (National Law Journal)
• Boehringer to pay $379,000 to settle charges of wage discrimination against female employees (STAT)