EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
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European molecular spectroscopy market to value $2.83bn by 2027
Research suggests the development of new instruments and growing government investments, particularly in Germany, will drive growth of the European molecular spectroscopy market.
ICMRA and WHO state clinical trial reports should be published without redaction
The International Coalition of Medicines Regulatory Authorities (ICMRA) and WHO are calling on pharma to provide voluntary unrestricted access to trial results data.
Highlights of the May 2021 Pharmacovigilance Risk Assessment Committee (PRAC) meeting
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
WHO lists Sinopharm’s COVID-19 vaccine for emergency use
The inactivated Vero Cell COVID-19 vaccine is now eligible for global rollout alongside the four other vaccines with World Health Organization Emergency Use Listing.
Benlysta approved for adult patients with active lupus nephritis in Europe
The indication of Benlysta (belimumab) was extended after it significantly improved renal outcomes in those with active lupus nephritis.
Atomic point contact significantly enhances Raman scattering
New research shows that allowing the atomic point of a tip-enhanced Raman spectrometer to touch the surface of a sample increases sensitivity.
Sonelokimab shows promise in Phase II psoriasis trial
In the trial, 57 percent of patients with moderate to severe psoriasis treated with 120mg of sonelokimab achieved total skin clearance in 24 weeks.
Scientists show 3D printed tablet porosity can regulate drug release
Investigators suggest using 3D printing to adjust tablet porosity could allow for personalised medicines to be made at the point-of-care.
AstraZeneca’s Tagrisso: first medicine approved in the UK under Project Orbis
Tagrisso (osimertinib) was approved for an indication extension after it reduced risk of death by over 80 percent in certain early-stage non-small cell lung cancer patients.
Calvert Laboratories acquired by Altasciences
According to Altasciences, the completed acquisition will increase small molecule expertise and add various study capabilities to its current pre-clinical offering.
Moderna’s COVID-19 variant booster vaccine shows promise in trial
Preliminary Phase II data shows a dose of mRNA-1273.351, Moderna’s strain-matched booster, is safe and may offer protection against the B.1.351 and P.1 variants of concern.
Novel vaccination regimen shown to be effective in preventing malaria
A three-dose regimen of Plasmodium falciparum sporozoites under chemoprophylaxis (PfSPZ-CVac) was shown to be safe, well tolerated and highly effective in a Phase II trial.
Novavax’s COVID-19 vaccine 49 percent effective against B.1.351 variant
New data shows NVX-CoV2373 offered complete protection against severe COVID-19 and 60 percent efficacy against infection with the B.1.351 variant in healthy adults.
Charles River Laboratories generates $824 million in first quarter
Charles River Laboratories International’s first quarter revenue was approximately 17 percent higher in Q1 2021, with organic revenue growth of 13 percent.
