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EU secures up to 1.8 billion additional doses of Comirnaty® COVID-19 vaccine
Pfizer and BioNTech have agreed to supply Europe with 900 million additional doses of Comirnaty® with the option to request 900 million more in future.
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EMA’s human medicines committee (CHMP) meeting highlights, May 2021
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
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CDMO sector are the big winner of the pandemic, state experts
In a presentation, experts revealed that contract services gained significantly through pandemic contracts but cautioned that capacity shortages could continue.
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Are COVID-19 vaccines effective for immunocompromised patients with haematological malignancies?
A new study will evaluate COVID-19 vaccines in patients with haematological malignancies who have received cellular therapy.
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Driving biopharma innovation post COVID-19
Ahmed Bouzidi, VP of Biotech Strategic Development at ProductLife Group, discusses the opportunities – and funding and regulatory challenges – facing small and mid-sized biopharma companies as they deliver innovation to the global market.
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mRNA COVID-19 vaccination is immunogenic in the immunocompromised
Research suggests patients who receive COVID-19 vaccines prior to a transplant and subsequent immunosuppression may be protected from the disease.
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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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Six major risks facing pharmaceutical manufacturers in 2021
In this article, Shannon Flynn outlines six of the key risks threatening pharmaceutical manufacturers’ recovery from COVID-19 in 2021.
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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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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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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.
