CMOs should invest in biologic API manufacturing capabilities, says GlobalData
Research shows the complexity and number of biologics is increasing, as is the frequency at which their active pharmaceutical ingredient (API) production is outsourced.
List view / Grid view
Research shows the complexity and number of biologics is increasing, as is the frequency at which their active pharmaceutical ingredient (API) production is outsourced.
The new report shows over 8,000 planned inspections were postponed due to COVID-19 and outlines the FDA’s plan for a more consistent future state of operations.
The Comirnaty® vaccine’s emergency use authorisation has been extended to allow its administration to those 12 years of age and above in the US.
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
In its May meeting, the EMA’s drug safety committee (PRAC) concluded two safety signal reviews for COVID-19 vaccines and began several more.
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.
This whitepaper discusses the analytical testing considerations for complex biological materials in ATMPs.
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.
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.
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 International’s first quarter revenue was approximately 17 percent higher in Q1 2021, with organic revenue growth of 13 percent.
Giovanni Di Guardo, DVM, Dipl. ECVP, retired Veterinary Pathologist, discusses the association between adenoviral vector COVID-19 vaccines and rare blood clots, outlining four areas warranting further research.
The EMA is evaluating whether to lower the age at which Comirnaty can be administered and Novavax has begun testing its COVID-19 vaccine in paediatric patients.
Phase III data shows Seqirus’ cell-based quadrivalent seasonal influenza vaccine was as effective and safe as an equivalent FDA-approved egg-based vaccine in paediatric patients.
Ten major tips for optimising techniques used by pharmaceutical research labs in their work on discovery and development of novel compounds.