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 …
Pfizer’s rheumatoid arthritis drug fails to meet safety criteria
January 28, 2021Pfizer
Pfizer has announced that its rheumatoid arthritis (RA) drug XELJANZ (tofacitinib) has failed to meet the co-primary endpoint in its …
Valneva begins production of its COVID-19 vaccine
January 28, 2021COVID-19, Valneva
Valneva, a specialty vaccine company focused on the prevention of infectious diseases with significant unmet medical needs, has commenced production …
NICE recommends Celgene’s REVLIMID for multiple myeloma
January 27, 2021Research 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 …
Diurnal and Citrine sign licensing agreement for Alkindi
January 27, 2021Research and Development Citrine, Diurnal
Diurnal Group has entered into an exclusive licence agreement for its product Alkindi (hydrocortisone granules in capsules for opening) with …
MSD’s cancer therapy KEYTRUDA gets EU approval
January 26, 2021Manufacturing 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 …
FDA approves Aurinia’s oral lupus nephritis therapy
January 26, 2021Manufacturing and Production Aurinia
The FDA has approved Aurinia Pharmaceuticals’ LUPKYNIS (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients …
Latest content
Major funding opportunity opens for early cancer diagnostics
Androlabs receives UK authorisation for new Testavan presentation
CEPI backs African-led Bundibugyo Ebola vaccine development
Cytomos appoints life sciences executive to board
