The FDA is expected to make a decision in April 2021. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for abrocitinib in the The post FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib appeared first on Pharmaceutical Business review.
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Gavi is the legal administrator of the COVAX Facility, which is part of COVAX, a global collaboration of governments, global health organisations, businesses and philanthropic organisations working to The post GSK, Sanofi to supply 200 million doses of Covid-19 vaccine to COVAX appeared first on Pharmaceutical Business review.
“The FDA approval of EYSUVIS as the first prescription therapy specifically developed to address the short-term treatment needs of people living with dry eye disease is a major The post Kala Pharmaceuticals announces FDA approval of EYSUVIS for short-term treatment of dry eye disease appeared first on Pharmaceutical Business review.
Aurinia has also secured funding for the VOCOVID study, which is a single-centre and investigator-initiated trial being carried out by Drs Aiko P.J. de Vries and Y.K. Onno The post Aurinia begins voclosporin trial in kidney transplant recipients with Covid-19 appeared first on Pharmaceutical Business review.
The multicentre trial has been designed to assess the safety and efficacy of oral niclosamide formulation to treat patients with moderate Covid-19 disease. The study is said to The post ANA Therapeutics starts oral niclosamide trial for Covid-19 treatment appeared first on Pharmaceutical Business review.
This randomized, placebo-controlled, ascending dose study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of HFB30132A in 24 healthy volunteers. A total of three cohorts The post HiFiBiO completes first cohort of phase 1 study of SARS-CoV-2 neutralising antibody appeared first on Pharmaceutical Business review.
“We appreciate the confidence of the Ministry of Health of Qatar in our mRNA vaccine platform and the collaboration we have had to date,” said Stéphane Bancel, Moderna’s The post Moderna to supply Qatar with mRNA vaccine against Covid-19 appeared first on Pharmaceutical Business review.
As per terms of the deal, Asklepios will secure an upfront consideration of $2bn and potential success-based milestone payments of up to $2bn from Bayer. Based in North The post Bayer to acquire Asklepios BioPharmaceutical for up to $4bn appeared first on Pharmaceutical Business review.
The Food and Drug Administration (FDA) today authorised the restart in the US, following the resumption of trials in other countries in recent weeks. The FDA reviewed all The post FDA authorises restart of the COVID-19 AZD1222 vaccine US phase 3 trial appeared first on Pharmaceutical Business review.
The orphan drug status to iptacopan has been granted by the regulator after a recommendation from the Committee for Orphan Medicinal Products (COMP). Although considered to be a The post Novartis’ iptacopan gets EMA’s orphan drug designation in IgAN appeared first on Pharmaceutical Business review.
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