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Regulatory Focus™ > News Articles > 2020 > 9 > Recon: Russian COVID vaccine shows antibody response in early trials; AbbVie to develop, sell I-Mab

Recon: Russian COVID vaccine shows antibody response in early trials; AbbVie to develop, sell I-Mab cancer drug

Posted 04 September 2020 | By Michael Mezher 

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.

 

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Tags: US, worldwide

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