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Phase III data update for CoronaVac in COVID-19 – Sinovac Biotech

Written by | 18 Feb 2021

Sinovac Biotech has announced phase III results of CoronaVac in COVID-19 treatment.

Merck Inc. receives positive CHMP opinion for expanded approval of Keytruda in certain patients with relapsed or refractory classical Hodgkin lymphoma

Written by | 17 Feb 2021

Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of an expanded… read more.

The Wits Vaccines and Infectious Diseases Analytics Research Unit, which runs the ChAdOx1 nCoV-19 vaccine trial in South Africa, has announced results

Written by | 16 Feb 2021

In an analysis, submitted as a pre-print prior to peer-review publication, a two-dose regimen of the ChAdOx1 nCoV-19 vaccine provides minimal protection against mild-moderate COVID-19 infection from the… read more.

EU approves expanded use of Spravato in depression – Janssen Pharma

Written by | 15 Feb 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Commission (EC) has authorised the expanded use of Spravato (esketamine nasal spray)..

European Commission approves Inrebic to treat myelofibrosis – BMS

Written by | 14 Feb 2021

Bristol Myers Squibb announced that the European Commission (EC) has granted full Marketing Authorization for Inrebic (fedratinib) for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in… read more.

EU approves Rukobia for HIV-1 infection – ViiV Healthcare

Written by | 13 Feb 2021

ViiV Healthcare, owned by GlaxoSmithKline, announced the European Marketing Authorisation of Rukobia (fostemsavir) 600mg extended-release tablets..

CHMP recommends approval of Ontozry for focal – onset (partial-onset) seizures – SK Biopharmaceuticals

Written by | 12 Feb 2021

SK Biopharmaceuticals announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use.

COVID-19 Vaccine AstraZeneca confirms 100% protection against severe disease, hospitalisation and death in the primary analysis of Phase III trials

Written by | 11 Feb 2021

The primary analysis of the Phase III clinical trials from the UK, Brazil and South Africa, published as a preprint in The Lancet confirmed COVID-19 Vaccine AstraZeneca is… read more.

EU approves Trimbow for asthma – Chiesi

Written by | 10 Feb 2021

The European Commission has approved a marketing authorisation for triple combination Trimbow (beclometasone + formoterol + glycopyrronium) from Chiesi, for patiemts with asthma therapy.

FDA approves intramuscular injection route of administration of Plegridy for multiple sclerosis – Biogen

Written by | 9 Feb 2021

Biogen Inc. announced that the FDA has approved a new intramuscular (IM) injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple… read more.

CHMP recommends once-weekly Sogroya to treat growth hormone deficiency – Novo Nordisk

Written by | 8 Feb 2021

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of once-weekly… read more.

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