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Regulatory Focus™ > News Articles > 2020 > 11 > Recon: UK asks MHRA to review Pfizer COVID vaccine; Novartis signs deal for Mesoblast cell therapy

Recon: UK asks MHRA to review Pfizer COVID vaccine; Novartis signs deal for Mesoblast cell therapy

Posted 20 November 2020 | By Michael Mezher 

Recon: UK asks MHRA to review Pfizer COVID vaccine; Novartis signs deal for Mesoblast cell therapy

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Pfizer is first to apply for US emergency use for COVID-19 vaccine (Reuters) (STAT)
  • 'We cannot rest': Despite promising Covid-19 vaccine results, trials must continue (NBC)
  • Five US agencies have started telling employees they could get Covid vaccine shots in as little as 8 weeks (CNBC)
  • Trump will announce on Friday rules to lower US drug prices (Reuters) (WSJ) (Politico)
  • Trump's vaccine team will not brief Biden administration: US senators (Reuters)
  • Eli Lilly arthritis drug gets FDA nod for emergency use with remdesivir to treat COVID-19 (Reuters) (FT)
  • ApiJect gets $590 million U.S. loan to produce COVID-19 vaccine injections (Reuters)
  • J&J, investment firm to pay $11.5M in drug device marketing probe (Reuters)
  • HIV Death Rates Fell by Half, CDC Says (NYTimes)
In Focus: International
  • UK asks regulator to assess Pfizer vaccine for suitability (Reuters)
  • EU could pay over $10 billion for Pfizer and CureVac vaccines (Reuters)
  • Sinovac may get Phase III trial results of COVID-19 vaccine by December, executive says (Reuters)
  • EU says no change to uses of Gilead's remdesivir after WHO guidance (Reuters)
  • Don't use Gilead's remdesivir in hospitalised COVID-19 patients, WHO says (Reuters) (STAT)
  • WHO suspends remdesivir from list of medicines (Reuters)
  • Institut Pasteur to keep working on three COVID-19 vaccines (Reuters)
  • Novartis signs $50 million deal for Mesoblast cell therapy for COVID, beyond (Reuters)
  • European Commission has asked EU members for vaccination plans: Merkel (Reuters)
  • AstraZeneca COVID-19 vaccine shows promise in elderly, trial results by Christmas (Reuters)
  • Alnylam scores European approval for rare disease med Oxlumo, plans 'sustainable' access deals (Fierce)
Coronavirus Pandemic
  • UK will set up dozens of mass vaccination centres as soon as vaccines are available: the Telegraph (Reuters)
  • Gene experts claim they identified human genes that can protect against Covid-19 (CNBC)
  • Many Employers Avoid Coronavirus Tests Over Cost, Not Availability (NYTimes)
  • India could get access to AstraZeneca vaccine by January, local manufacturer says (Reuters)
  • Brazil will not exempt COVID-19 vaccine makers from liability, deputy minister says (Reuters)
  • Israel nears deal for AstraZeneca's COVID-19 vaccine (Reuters)
  • Spain eyes 'substantial' vaccination in first half 2021, contagion slows (Reuters)
  • EU warns Hungary against use of Russia's COVID-19 vaccine (Reuters)
  • Siemens Healthineers to offer antibody test for quantifying COVID-19 immunity (Fierce)
  • HHS piloting Cue's NBA-tested rapid COVID-19 diagnostic in 5 states (MedtechDive)
Pharma & Biotech
  • Launch Of EU Clinical Trial Portal Moves A Step Closer (Pink Sheet)
  • EU Prepares To Reveal Pharma Strategy (Pink Sheet)
  • Cancer vaccine cocktail boosts immune response after melanoma surgery, research shows (STAT)
  • To maintain opioid sales, Purdue was advised to pay rebates to health insurers for each overdose (STAT)
  • Pierre Fabre’s Braftovi scores NICE backing for BRAF+ colorectal cancer (PMLive)
  • EU Review Gets Under Way For Curative Vision Loss Gene Therapy (Pink Sheet)
  • Biotech: The Featherweight Champion Of The Markets (LifeSciVC)
  • Gene therapy hemophilia B 'cure' approach heats up as uniQure/CSL, rivaling Pfizer, shows promise (Fierce) (BioPharmaDive)
  • Rx Drug Promotion: Potential Enforcement Worries (Pink Sheet)
  • Fresenius Kabi recalls hospital sedative on accidental mix with lidocaine—again (Fierce) (FDA)
  • ‘Exceptional’ cancer patients yield clues to better drug treatments (Science)
  • News briefing: ADC gets a speedy FDA review for their DLBCL therapy; Qiagen teams with the world's new favorite biotech (Endpoints)
  • Vivek Ramaswamy’s Metavant hits a brick wall, abandoning a lead program for diabetes. And there’s nothing visible left to see here (Endpoints)
  • World leaders join forces to fight the accelerating crisis of antimicrobial resistance (WHO)
  • WHO and other stakeholders join forces to accelerate access to effective paediatric HIV and tuberculosis diagnostics and medicines (WHO)
Medtech
  • GE health unit buys Swedish start-up Prismatic Sensors, bolstering key medical imaging business (CNBC)
  • Notified bodies report early success with remote audits but challenges remain (MedtechDive)
  • Notified Body Pain Points: The Challenges And Obstacles Industry Needs To Avoid (MedtechInsight)
  • MedTech Europe likes proposed EU Health Union but flags potential concerns (MedtechDive)
  • FDA Cobbles Together Pilot For Remote Review Of Manufacturer Records (MedtechInsight)
  • US FDA introduces Certificate for Device Not Exported from the United States (CDNE) (Emergo)
Government, Regulatory & Legal
  • AmerisourceBergen Held In Contempt In Wash. Opioid Suit (Law360)
  • Fed. Circ. Affirms $107M Inhaler IP Judgment Against GSK (Law360)
  • Former MiMedx CEO and COO are convicted on fraud, conspiracy charges (Endpoints)
  • Biomedical Research: NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property (GAO)
  • Johnson & Johnson ordered to pay $120 million damages in New York baby powder case (Reuters)
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.

Tags: US, worldwide

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