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gocovri

Adamas’ Parkinson’s drug gets US marketing authorisation for second indication

February 2, 2021
Manufacturing and Production Adamas Pharmaceuticals, FDA

The FDA has granted marketing authorisation for a second indication for Adamas Pharmaceuticals’ Gocovri (amantadine) extended release capsules. The drug …

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EMA grants marketing authorisation for Amarin’s heart attack treatment

February 1, 2021
Sales and Marketing Amarin, EMA

Amarin have been granted authorisation from the EMA to market a treatment that will reduce the chance of heart attacks …

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Johnson & Johnson’s single-shot COVID-19 vaccine 85% effective

February 1, 2021
Sales and Marketing COVID-19, Johnson & Johnson, vaccines

Johnson & Johnson has announced that its COVID-19 vaccine candidate is 85% effective in preventing serious symptoms of the disease, …

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xarelto_10_tablet1

Bayer’s venous thromboembolism drug Xarelto gets UK approval for children

February 1, 2021
Sales and Marketing Bayer

Bayer has received UK approval for the use of its oral Factor Xa inhibitor Xarelto (rivaroxaban) to treat venous thromboembolism …

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sos002

Sosei Heptares and Metrion Biosciences to collaborate on structure-based drug discovery approaches to ion channels

February 1, 2021
Sales and Marketing Sosei Heptares

Sosei Heptares has announced it will collaborate with Metrion Biosciences, a specialist ion channel CRO and drug discovery company, to …

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CHMP recommends marketing authorisation for Novartis’ Kesimpta

February 1, 2021
Sales and Marketing Novartis, multiple sclerosis

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing authorisation of Novartis’ Kesimpta (ofatumumab) for …

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Pharmafile.com’s top 10 news stories of the week

January 29, 2021
Medical Communications

Most of Pharmafile.com’s top stories this week concern the approval of various treatments in the US, UK, and EU – …

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AstraZeneca COVID-19 vaccine not for over 65s, German health body says

January 29, 2021
Medical Communications AstraZeneca, COVID-19

Germany’s main public health body has recommended that AstraZeneca’s COVID-19 vaccine is only administered to those aged between 18 and …

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novavax

Novavax COVID-19 vaccine shows almost 90% efficacy in Phase III trial

January 29, 2021
Medical Communications COVID-19, Novavax

Novavax has announced that its COVID-19 vaccine candidate, NVX-CoV2373, demonstrated an efficacy of 89.3% in its UK Phase III trial. …

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leiden

Toxys and Leiden University to commercialise and develop animal-free toxicity testing platform

January 29, 2021
Medical Communications Toxys

Toxys, Leiden University, and Leiden University Medical Center have agreed to commercialise and develop further the ToxProfiler technology invented at …

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opaganib-bottle-and-tablets

RedHill expands manufacturing capacity for opaganib with Cosmo

January 29, 2021
Medical Communications RedHill Biopharma

RedHill Biopharma has announced a manufacturing agreement with Cosmo Pharmaceuticals to further expand manufacturing capacity for opaganib (Yeliva), to address …

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EMA accepts Global Blood Therapeutics’ MAA for Oxbryta

January 28, 2021
Global Blood Therapeutics

The EMA has accepted Global Blood Therapeutics (GBT)’s Marketing Authorisation Application (MAA) for Oxbryta (voxelotor) tablets, and has started its …

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Pfizer-BioNTech COVID-19 vaccine effective against South Africa variant, companies say

January 28, 2021

Pfizer and BioNTech have said that their COVID-19 vaccine is effective in protecting against the variant of the virus found …

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Harbour BioMed’s Batoclimab granted Breakthrough Therapy designation in China

January 28, 2021
Harbour BioMed

Harbour BioMed (HBM) has announced that China’s Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab, a …

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Pfizer’s rheumatoid arthritis drug fails to meet safety criteria

January 28, 2021
Pfizer

Pfizer has announced that its rheumatoid arthritis (RA) drug XELJANZ (tofacitinib) has failed to meet the co-primary endpoint in its …

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valneva

Valneva begins production of its COVID-19 vaccine

January 28, 2021
COVID-19, Valneva

Valneva, a specialty vaccine company focused on the prevention of infectious diseases with significant unmet medical needs, has commenced production …

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celgene_building

NICE recommends Celgene’s REVLIMID for multiple myeloma

January 27, 2021
Research and Development Cancer, Celgene

NICE has issued a Final Appraisal Document (FAD) recommending Celgene’s REVLIMID (lenalidomide) as maintenance treatment after an autologous stem cell …

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Diurnal and Citrine sign licensing agreement for Alkindi

January 27, 2021
Research and Development Citrine, Diurnal

Diurnal Group has entered into an exclusive licence agreement for its product Alkindi (hydrocortisone granules in capsules for opening) with …

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european_commission_web

MSD’s cancer therapy KEYTRUDA gets EU approval

January 26, 2021
Manufacturing and Production Cancer, MSD

MSD, known as Merck in the US and Canada, has received approval from the European Commission (EC) for its anti-PD-1 …

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fdaoutsideweb

FDA approves Aurinia’s oral lupus nephritis therapy

January 26, 2021
Manufacturing and Production Aurinia

The FDA has approved Aurinia Pharmaceuticals’ LUPKYNIS (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients …

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