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Recon: Russian COVID vaccine shows antibody response in early trials; AbbVie to develop, sell I-Mab cancer drug
Recon: Russian COVID vaccine shows antibody response in early trials; AbbVie to develop, sell I-Mab cancer drug
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Covid-19 Vaccine Race Turns Deep Freezers Into a Hot Commodity (WSJ )
Leader of US vaccine push says he‘ll quit if politics trumps science (Science ) (NPR )
US will not 'cut corners' in developing coronavirus vaccine, Pence says (Reuters )
White House: no one pressuring FDA to approve coronavirus vaccine (Reuters )
Moderna slows vaccine trial enrollment to ensure minority representation: CEO (CNBC )
Roche receives US emergency approval for coronavirus vs. flu test (Reuters )
Amarin loses patent appeal and their brief grip on fish oil empire (Endpoints ) (Law360 ) (Patent Docs )
Hahn, HHS in ‘tit for tat’ feud over Covid-19 messaging (Politico )
In Focus: International
Widespread COVID-19 vaccinations not expected until mid-2021, WHO says (Reuters )
Russia’s Covid Vaccine Shows Potential in Peer Review, Lancet Reports (Bloomberg ) (Reuters ) (The Lancet )
Curevac gets $300 million grant to hurry up COVID-19 vaccine (Reuters )
Japan says it will bear cost of coronavirus vaccines for populace (Reuters )
UNICEF says drugmakers can produce unprecedented vaccine quantities for COVID-19 (Reuters )
Drugs That Fight Diabetes and Obesity May Treat Covid-19 (Bloomberg )
AbbVie to develop and sell China-based I-Mab's cancer drug (Reuters ) (Endpoints ) (Press )
Coronavirus Pandemic
Diagnostics group Novacyt launches two gene COVID-19 test (Reuters )
Debate rages over whether FDA should use emergency powers to clear a coronavirus vaccine early (Washington Post )
Johnson & Johnson says coronavirus vaccine prevents severe illness in hamsters (CNBC )
AstraZeneca signs on Albany Molecular to help boost COVID-19 shot production (Fierce )
PMDA Presents Views on Efficacy, Safety Evaluations for Domestic Development of COVID-19 Vaccines (PharmaJapan )
FDA eyes self-administered testing for COVID-19 antigen tests (BioWorld )
Contact tracing foiled by conspiracy theories, lack of federal messaging (Politico )
Coronavirus (COVID-19) Update: Daily Roundup September 3, 2020 (FDA )
Pharma & Biotech
Vertex and Covid-19 spell the end for Savara's CF program (Endpoints )
US FDA Hiring Strategy Shifts Focus From ‘Vacancies’ To ‘Net Gains’ (Pink Sheet )
Kite looks to expand Yescarta franchise with new indications; Tiny Lixte looks to uplist on Nasdaq (Endpoints )
Scott Edmondson leaves AstraZeneca, starts new chapter at Nimbus; With IPO filed, Taysha pulls together an AveXis-heavy team (Endpoints )
Insilico's weeks-old aging research spinout Deep Longevity picked up by Regent Pacific (Fierce )
China biotech InxMed bags $19M Series A+ to develop PhI FAK inhibitor (Endpoints )
How To Narrow The Evidence Gap For Histology Independent Drugs (Pink Sheet )
Researchers at City of Hope combine oncolytic virus with a CAR-T to eradicate solid tumors in mice (Endpoints )
FDA approves additional doses of Trulicity® (dulaglutide) for the treatment of type 2 diabetes (Press )
Medtech
Abbott to hire 2,000 in Illinois to make rapid COVID-19 test (MassDevice )
FDA flags 428 spinal cord stimulator patient deaths, urges more checks to ensure pain relief (MedtechDive )
Boston Scientific, Stryker win CMS new tech add-on pay, BD left out (MedtechDive )
CMS rate cuts for Abiomed Impella not as bad as expected (MassDevice )
Viz.ai stroke software lands Medicare ‘new technology’ coverage (MassDevice )
Medtronic touts cryoablation therapy study results (MassDevice )
Abbott resurrects resorbable scaffold tech for below-the-knee trial (MedtechDive )
'Coming into their own': FDA approval of liquid biopsy tests puts early, less invasive cancer detection in broader reach (USA Today )
Government, Regulatory & Legal
Reynolds Seeks FDA Nod to Reintroduce Mixed Berry E-Cigarettes (Bloomberg )
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.