Recon: FDA approves Sunovion Parkinson’s drug; Oxford-AZ vaccine moving to Phase 2/3 trials

• A quarter of Americans are hesitant about a coronavirus vaccine - Reuters/Ipsos poll (Reuters)
• Drug touted by Trump as COVID-19 treatment tied to increased risk of death: study (Reuters) (Washington Post) (STAT) (The Lancet)
• Prominent Scientists Denounce End to Coronavirus Grant (NYTimes) (Science)
• 'This is a bad practice': Doctors question FDA protocol for plasma treatment of coronavirus patients (Yahoo)
• FDA OKs first generic for Amarin's Vascepa, but is a fish oil price war imminent? (Endpoints) (Press)
• Vanda Pharmaceuticals CEO's Proposal on Clinical Trial Data Sharing, COVID-19 and Remdesivir
• (Vanda)
• Another NASH delay for Intercept frustrates investors, shares wilt (Endpoints) (BioPharmaDive)
• FDA approves Parkinson's treatment from Sunovion Pharma (Reuters) (Endpoints)
• FDA investigates lab as tens of thousands of COVID test results in FL are questioned (USA Today)
• Abbott says new data on rapid coronavirus test used in White House shows high accuracy (Reuters)
• US urges WHO to start review of pandemic response, seeks reforms (Reuters)

• Sinovac says it has started mid-stage human trials of COVID-19 vaccine (Reuters)
• Roche buys U.S. gene sequencing tech company Stratos Genomics (Reuters) (Press)
• Britain to buy 10 million antibody tests from Roche and Abbott (Reuters)
• Fujifilm pictures new pharma-heavy identity with Avigan (Nikkei)
• NICE u-turn backs Roche's Tecentriq for triple negative breast cancer (PharmaTimes)
• Human trials of British coronavirus vaccine to reach 10,000 (Reuters) (BBC)
• South Korea's Samsung Biologics signs $231 million supply deal with GSK (Reuters) (Endpoints)
• Polio and Measles Could Surge After Disruption of Vaccine Programs (NYTimes) (Reuters)
• China to bolster disease control system in post-virus overhaul (Reuters)
• Global COVID-19 trial of hydroxychloroquine, which Trump takes, begins (Reuters)

• Rapid repurposing of drugs for COVID-19 (Science)
• Fauci says it’s still possible that a coronavirus vaccine will be available in the U.S. by December (CNBC) (NPR)
• U.S. doctors call for remdesivir data to guide coronavirus treatment (Reuters)
• Inovio CEO on the COVID-19 vaccine race: Don’t count us out (Fierce)
• Philanthropists play a crucial role in developing vaccines (FT)
• The world needs Covid-19 vaccines. It may also be overestimating their power (STAT)
• Treating Mild Coronavirus Cases Could Help Save Everyone (NYTimes)
• Coronavirus (COVID-19) Update: Daily Roundup May 21, 2020 (FDA)

• Coronavirus Tests The Value Of Artificial Intelligence In Medicine (KHN)
• Patients frantic over mysterious global shortage of HRT medications and contraceptive pills (The Guardian)
• When A Sponsor Wants To Proceed On A COVID Product, US FDA Almost Never Says No (Pink Sheet)
• US FDA Pushing Coronavirus Trial Sponsors To Include Control Groups (Pink Sheet)
• US FDA Generic Approvals Peak In April, But Annual Pace Trends Down (Pink Sheet)
• Covid-19 has brought on a case of corporate good citizenship at AstraZeneca (FT)
• Genentech posts long-term data on near-approval Soliris rival (Fierce)
• Will established generics firms take Trump's cue and bring drug manufacturing to the U.S.? (Fierce)
• How Civica helped under-the-radar Phlow nab a $354M COVID-19 manufacturing deal (Fierce)
• The man who led Gilead’s autoimmune pivot heads to Boston; Novartis gets a new chief for its AI Innovation Center (Endpoints)
• Restructured Melinta now wants to buy fellow antibiotic maker Tetraphase; TA Associates mulls $500M deal for a stake in CDMO (Endpoints)
• India’s Department of Pharmaceuticals proposes to oversee drug regulator (Economic Times)
• European Medicines Agency Validates Bristol Myers Squibb’s Applications for Idecabtagene Vicleucel (Ide-cel, bb2121) and CC-486 (Press)
• ENHERTU® Granted Orphan Drug Designation in the U.S. for Gastric Cancer (Press)
• New longer-term data reinforce safety of Roche’s satralizumab in adults and adolescents with neuromyelitis optica spectrum disorder (Press)

• Diagnostics and the coronavirus: don’t let the standards slip (Nature)
• Report: New Medtronic CEO challenges Trump on ‘reshoring’ (MassDevice)
• 15 heart devices that could boost their manufacturers’ sales (MassDevice)

• Congress Said COVID-19 Tests Should Be Free — But Who’s Paying? (KHN)
• Drug Buyers' Retooled $34M Celgene Deal Wins Initial OK (Law360)
• How Pandemic-Related Delays Affect Hatch-Waxman Litigants (Law360)
• CBD Co. Issues Recall After FDA Warning Letter (Law360)
• Company issued $12,600 infringement notice for alleged COVID-19 advertising breach (TGA)