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Chelsea & Westminster Hospital launches diabetes care app

February 2, 2021
Manufacturing and Production

Chelsea and Westminster Hospital NHS Foundation Trust have today announced the use of a new app designed to revolutionise diabetes …

News
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FDA approves new IM administration route for Biogen’s MS drug Plegridy

February 2, 2021
Manufacturing and Production Biogen, MS

The FDA has approved a new intramuscular (IM) injection route of administration for Biogen’s Plegridy (peginterferon beta-1a) for the treatment …

News
merckincweb

Combination of Keytruda and Yervoy does not improve cancer survival, MSD trial finds

February 2, 2021
Manufacturing and Production Cancer, MSD

A new trial by Merck – known as MSD outside of North America – has found that their lung cancer …

News

EMA recommends Arvelle’s seizure drug cenobamate

February 2, 2021
Manufacturing and Production Arvelle Therapeutics, epilepsy

The EMA has recommended the approval of Arvelle Therapeutics’ cenobamate for the adjunctive treatment of focal onset seizures with or …

News
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 …

News

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 …

News

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, …

News
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 …

News
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 …

News
novartis_window

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 …

News
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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 – …

News
astrazeneca-sign

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 …

News
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. …

News
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 …

News
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 …

News
oxbryta-bottle-and-pills

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 …

News
pfizer_building_logo1

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 …

News
china_flag

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 …

News

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 …

News
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 …

News
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