Recon: US to make coronavirus strain for challenge trials; EU reaches first COVID-19 vaccine deal with AstraZeneca

• Top US health official says approval of COVID vaccines unlikely before November (Reuters)
• Fauci believes normalcy will return by "the end of 2021" with coronavirus vaccine (Axios)
• Johnson & Johnson invests in Thirty Madison, signaling the resilience of pharma’s interest in health tech (STAT)
• US to make coronavirus strain for possible human challenge trials (Reuters) (Endpoints)
• Vaccine makers including Moderna must hit US timing goals for full payments (Reuters)
• Mesoblast’s Cell Therapy For Pediatric GVHD Gets US Panel Green Light Despite FDA's "Substantial Concerns" (Pink Sheet) (Endpoints)
• The US has already invested billions in coronavirus vaccines. Here’s where the deals stand (CNBC)

• EU agrees first COVID-19 vaccine deal with AstraZeneca in WHO blow (Reuters)
• AstraZeneca set to start making 400 million COVID-19 vaccines for Latam early in 2021 (Reuters)
• Britain lines up more potential COVID-19 vaccine supplies with J&J, Novavax deals (Reuters)
• China Sinopharm's potential COVID-19 vaccine triggers antibodies in clinical trials: journal (Reuters)
• Russian doctors wary of rapidly approved COVID-19 vaccine, survey shows (Reuters)
• Vietnam to buy Russian COVID-19 vaccine (Reuters)
• Coronavirus vaccine developer CureVac raises $213 million in IPO (Reuters) (STAT)
• Indian drug companies seek cure for Donald Trump’s 'Buy-American' plan (Economic Times)
• INCB, WHO and UNODC statement on access to internationally controlled medicines during COVID-19 pandemic (WHO)

• Clinical Trials of Coronavirus Drugs Are Taking Longer Than Expected (NYTimes)
• Covid-19 clinical trials are failing to enroll diverse populations, despite awareness efforts (STAT)
• House Panel Seeks Answers On Virus Vaccine Campaign (Law360) (House)
• Testing mess leaves Texas in the dark as cases spike (Politico)
• As COVID-19 cases rise in U.S., precious plasma donations lag (Reuters)
• Russia's top respiratory doctor quits over 'gross violations' of medical ethics that rushed through Putin's coronavirus 'vaccine' (Daily Mail)
• TB vaccine shows encouraging results against coronavirus in phase-3 clinical trials (Economic Times)
• Beset by Coronavirus, Health Authorities Brace for Flu Season (WSJ)
• How a biotech CEO figured out Covid-19 surveillance testing for 50 companies with 12-hour turnaround times (CNBC)
• HHS commits $6.5M to add Thermo Fisher, Beckman Coulter COVID-19 test supplies to Aegis, Sonic labs (MedtechDive)
• Coronavirus (COVID-19) Update: Daily Roundup August 13, 2020 (FDA)

• Doctors say antibiotic resistance is an issue — but most say they’re not part of the problem (STAT)
• Critics Wonder Whether The FDA Is Too Slow To Handle A Pandemic (Forbes)
• “Somehow the CR Will Pass”, But When? (Alliance for a Stronger FDA)
• Many psoriasis patients are paying higher prices than ever at the pharmacy counter (STAT)
• The FDA's Best Tips For Avoiding Drug Master File Setbacks (Pink Sheet)
• US FDA Urged To Drop Snail Mail For IND Communications (Pink Sheet)
• The Quality Lowdown: COVID-19's Pressures On Drug Quality (Pink Sheet)
• Galapagos signs deal with Scipher for IBD drug development (PharmaTimes)
• UnitedHealthcare spurns Gilead's newer PrEP drug Descovy as Truvada generic looms: report (Fierce)
• Eyeing in-vivo editing, Mammoth licenses Jennifer Doudna’s new CRISPR enzyme (Endpoints)
• Roche Provides Update on Etrolizumab Trials (Big Molecule Watch)
• Tazverik Accelerated Approval: Disease Rarity And Unmet Need Won Out Over Efficacy Concerns (Pink Sheet)
• TG Therapeutics scores priority review for PI3Kδ inhibitor; Galapagos searches for IBD targets in new pact (Endpoints)
• BioMarin CSO disses rivals for the hemophilia A gene therapy crown: Way behind, facing big recruitment challenges and at best a .6 on the gen-one scale (Endpoints)
• 'We want to be everywhere.' Mission Bio raises $70M behind resistance-hunting sequencing platform (Endpoints)
• Sanofi vet Katherine Bowdish named CEO of PIC Therapeutics; As the world Terns: Liver disease biotech makes executive changes (Endpoints)

• FDA clears Masimo index to better track ventilated patients (MassDevice)
• Watchdog again pushes CMS to add UDIs to claim forms (MedtechDive)
• CMS seeks to ease rules on artificial heart, ventricular assist device coverage (MedtechDive)

• Federal appeals court rejects preemption argument from BD’s Bard (MassDevice)
• FDA Must Widen Abortion Pill Access During in-Person Rule Appeal (Bloomberg Law)
• McKesson, Cardinal Get Green Light For Opioid Bench Trial (Law360)
• Martin Shkreli continued to orchestrate anti-competitive schemes for Daraprim behind bars — FTC (Endpoints)
• Pharmacy Pays $3.5M To Settle DOJ Medicare Kickback Probe (Law360)
• Another Arizona Court Strikes a Plaintiff’s Request for Punitive Damages (Drug & Device Law)