EMA Archives

News and Trends 5 Aug 2022

Abivax has approval granted to enroll ulcerative colitis patients in two studies

Patients with moderate to severe ulcerative colitis (UC) can now be enrolled onto two phase 3 induction studies for a biotech company’s lead candidate drug. France-based Abivax SA is a phase 3 clinical stage biotech company that focuses on developing therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer. […]

August 5, 2022 - 3 minutesmins - By Liza Laws

News and Trends 28 Jul 2022

First of a kind multiple sclerosis biosimilar natalizumab accepted by US Food and Drug Association

Sandoz, a global pharmaceutical company working in generic and biosimilar medicines, announced this week that the US Food and Drug Administration (FDA) has accepted its biologics application (BLA) for treatment for people with multiple sclerosis (MS). The application is for a biosimilar natalizumab developed by Polpharma Biologics and includes all indications covered by the reference […]

July 28, 2022 - 3 minutesmins - By Liza Laws

News and Trends 25 Jul 2022

Drug that could be the first and only in Europe to treat rare brain condition recommended for marketing authorization

The Committee for Medical Products for Human Use (CHMP) has recommended the European Commission (EC) make a marketing authorization under exceptional circumstances for a drug to treat a rare condition characterized by brain dysfunction. The drug is called NULIBRY (fosdenopterin) for injection therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A. […]

July 25, 2022 - 4 minutesmins - By Liza Laws

lupus autoimmune disease neutrophil citryll

News and Trends 22 Jul 2022

Positive news for Aurinia’s voclosporin drug Lupkynis to treat lupus nephritis

British Columbia-based Aurinia Pharmaceuticals Inc. announced today (July 22) that its voclosporin drug has been recommended for marketing authorization to treat adults with active lupus nephritis (LN). The Canadian biopharma company said it is committed to delivering therapeutics that change the course of autoimmune disease after the Committee for Medicinal Products for Human Use (CHMP) […]

July 22, 2022 - 3 minutesmins - By Liza Laws

News and Trends 22 Jul 2022

Stroke drug given priority medicine status by European Medicines Agency

A biotech company developing drugs for cardiovascular emergencies, specifically strokes, has received priority medicines status from the European Medicines Agency (EMA) for its drug candidate, glenzocimab. Paris-based Acticor Biotech made the announcement yesterday (July 21) and the prime status allows reinforcement of support for the development of drugs that target an unmet medical need. It […]

July 22, 2022 - 2 minutesmins - By Liza Laws

News and Trends 19 Jul 2022

Good news for Destiny Pharma’s nasal gel to combat life-threatening infections

Clinical stage biotech company, Destiny Pharma, announced today (July 19) a positive update from the U.S. Food and Drug Administration (FDA) on its XF-73 nasal gel phase 3 development plans. The FDA has clarified the phase 3 and U.S. registration pathway for the gel for the prevention of post-surgical staphylococcal infections, and this feedback enables […]

July 19, 2022 - 5 minutesmins - By Liza Laws

geneuro multiple sclerosis neuron viral dna

News and Trends 18 Jul 2022

First-ever Marketing Authorization Application for biosimilar targeting MS filed

An international biotech, with headquarters in Amsterdam, has announced that the European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for its biosimilar product. Polpharma Biologics, which is dedicated to the development of biosimilars, announced on Friday (July 15) that natalizumab, similar to Tysabri, which treats multiple sclerosis, has been accepted as […]

July 18, 2022 - 3 minutesmins - By Liza Laws

Kintor Pharmaceutical drug gets positive results for breast cancer

News and Trends 28 Jun 2022

Breast cancer drug recommended for approval

A cancer drug from AstraZeneca and Daiichi Sankyo called Enhertu, that reduces the risk of disease progression or even death by 72%, has been recommended for approval in the European Union (EU). The drug containing trastuzumab deruxtecan is specifically engineered for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer treated with […]

June 28, 2022 - 3 minutesmins - By Liza Laws

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