New urine test could detect womb cancer in three hours
February 3, 2021Research and Development Cancer, urine test
A simple test using patented technology to detect the cancer biomarker MCM5 (Minichromosome Maintenance Complex Component 5) in urine could …
Scenic Biotech appoints Dr Philippe Dro as Chairman
February 2, 2021Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing
Scenic Biotech has announced the appointment of Dr Philippe Dro as its independent Chairman. Dr Dro replaces Dr Ulrich Grau, …
Chelsea & Westminster Hospital launches diabetes care app
February 2, 2021Manufacturing and Production
Chelsea and Westminster Hospital NHS Foundation Trust have today announced the use of a new app designed to revolutionise diabetes …
FDA approves new IM administration route for Biogen’s MS drug Plegridy
February 2, 2021Manufacturing 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 …
Combination of Keytruda and Yervoy does not improve cancer survival, MSD trial finds
February 2, 2021Manufacturing and Production Cancer, MSD
A new trial by Merck – known as MSD outside of North America – has found that their lung cancer …
EMA recommends Arvelle’s seizure drug cenobamate
February 2, 2021Manufacturing 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 …
Adamas’ Parkinson’s drug gets US marketing authorisation for second indication
February 2, 2021Manufacturing 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 …
EMA grants marketing authorisation for Amarin’s heart attack treatment
February 1, 2021Sales and Marketing Amarin, EMA
Amarin have been granted authorisation from the EMA to market a treatment that will reduce the chance of heart attacks …
Johnson & Johnson’s single-shot COVID-19 vaccine 85% effective
February 1, 2021Sales 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, …
Bayer’s venous thromboembolism drug Xarelto gets UK approval for children
February 1, 2021Sales and Marketing Bayer
Bayer has received UK approval for the use of its oral Factor Xa inhibitor Xarelto (rivaroxaban) to treat venous thromboembolism …
Sosei Heptares and Metrion Biosciences to collaborate on structure-based drug discovery approaches to ion channels
February 1, 2021Sales and Marketing Sosei Heptares
Sosei Heptares has announced it will collaborate with Metrion Biosciences, a specialist ion channel CRO and drug discovery company, to …
CHMP recommends marketing authorisation for Novartis’ Kesimpta
February 1, 2021Sales 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 …
Pharmafile.com’s top 10 news stories of the week
January 29, 2021Medical Communications
Most of Pharmafile.com’s top stories this week concern the approval of various treatments in the US, UK, and EU – …
AstraZeneca COVID-19 vaccine not for over 65s, German health body says
January 29, 2021Medical 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 …
Novavax COVID-19 vaccine shows almost 90% efficacy in Phase III trial
January 29, 2021Medical 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. …
Toxys and Leiden University to commercialise and develop animal-free toxicity testing platform
January 29, 2021Medical Communications Toxys
Toxys, Leiden University, and Leiden University Medical Center have agreed to commercialise and develop further the ToxProfiler technology invented at …
RedHill expands manufacturing capacity for opaganib with Cosmo
January 29, 2021Medical Communications RedHill Biopharma
RedHill Biopharma has announced a manufacturing agreement with Cosmo Pharmaceuticals to further expand manufacturing capacity for opaganib (Yeliva), to address …
EMA accepts Global Blood Therapeutics’ MAA for Oxbryta
January 28, 2021Global Blood Therapeutics
The EMA has accepted Global Blood Therapeutics (GBT)’s Marketing Authorisation Application (MAA) for Oxbryta (voxelotor) tablets, and has started its …
Pfizer-BioNTech COVID-19 vaccine effective against South Africa variant, companies say
January 28, 2021Pfizer and BioNTech have said that their COVID-19 vaccine is effective in protecting against the variant of the virus found …
Harbour BioMed’s Batoclimab granted Breakthrough Therapy designation in China
January 28, 2021Harbour 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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