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Regulatory Focus™ > News Articles > 2020 > 5 > Recon: FDA approves Sunovion Parkinson’s drug; Oxford-AZ vaccine moving to Phase 2/3 trials

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

Posted 22 May 2020 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government & Regulatory
  • 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)
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.
A story's inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

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