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New harmonised guidance for post-approval changes released by FDA
The FDA has published its finalised guidance for drug lifecycle management, including an improved framework for the management of post-approval changes.
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Biologics
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Johnson & Johnson to donate 200,000 vaccine regimens to curb Ebola outbreak
To prevent the spread of the Ebola virus in West Africa, Johnson & Johnson is donating vaccines for a WHO early access clinical programme.
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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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Pakistan approves Zofin™ for compassionate use in COVID-19 patient
Organicell’s Zofin™ therapy has been approved by the Pakistani regulators to be used for a patient with severe COVID-19 on compassionate grounds.
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FDA allows Pfizer’s COVID-19 vaccine to be used in adolescents
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.
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Real-time bioprocess Raman analyser market to achieve significant growth
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.
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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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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.
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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.
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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.
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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.
whitepaper
Whitepaper: Analytical testing considerations for ATMPs
This whitepaper discusses the analytical testing considerations for complex biological materials in ATMPs.
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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.
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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.
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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.
