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.
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Research shows the complexity and number of biologics is increasing, as is the frequency at which their active pharmaceutical ingredient (API) production is outsourced.
Organicell’s Zofin™ therapy has been approved by the Pakistani regulators to be used for a patient with severe COVID-19 on compassionate grounds.
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.
Market research shows the adoption of process analytical technologies and investment in pharma R&D and healthcare will drive growth in the real-time bioprocess Raman analyser market.
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.
The indication of Benlysta (belimumab) was extended after it significantly improved renal outcomes in those with active lupus nephritis.
In the trial, 57 percent of patients with moderate to severe psoriasis treated with 120mg of sonelokimab achieved total skin clearance in 24 weeks.
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.
With roughly a fifth of the mass spectrometry market made up by pharma and biotech, growing R&D investment and technological breakthroughs in mass spectrometers will contribute to market growth.
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.