FDA grants priority review and EMA accepts regulatory submission for Pfizer’s abrocitinib

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

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GSK, Sanofi to supply 200 million doses of Covid-19 vaccine to COVAX

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

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Kala Pharmaceuticals announces FDA approval of EYSUVIS for short-term treatment of dry eye disease

“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

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Aurinia begins voclosporin trial in kidney transplant recipients with Covid-19

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

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ANA Therapeutics starts oral niclosamide trial for Covid-19 treatment

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

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HiFiBiO completes first cohort of phase 1 study of SARS-CoV-2 neutralising antibody

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

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Moderna to supply Qatar with mRNA vaccine against Covid-19

“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

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Bayer to acquire Asklepios BioPharmaceutical for up to $4bn

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

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FDA authorises restart of the COVID-19 AZD1222 vaccine US phase 3 trial

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

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Novartis’ iptacopan gets EMA’s orphan drug designation in IgAN

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

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