News and Trends 31 Aug 2022 United BioPharma gets FDA approval for phase 2 HIV drug trial Taiwan-headquartered United BioPharma (UBP) says the U.S. Food and Drug Administration (FDA) has approved a phase 2 clinical trial IND submitted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of NIH. The purpose of the study is to assess the safety and antiviral activity of UB-421 in combination with optimized background ART […] August 31, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 31 Aug 2022 Emactuzumab designated as an orphan medicinal product for TGCT in Europe SynOx Therapeutics Limited says its novel monoclonal antibody, emactuzumab, in development for the treatment of tenosynovial giant cell tumor (TGCT) and other diseases, has been designated as an orphan medicinal product for both localized and diffuse types of the disease by the European Medicines Agency (EMA). No systemic treatments have been approved for TGCT in […] August 31, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 24 Aug 2022 Northwest Biotherapeutics’ pediatric investigation plan approved by MHRA Northwest Biotherapeutics, a biotech company developing DCVax personalized immune therapies for solid tumor cancers, has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its pediatric investigation plan (PIP). The development, regulatory review and regulatory approval of a PIP is a pre-requisite for application for approval of a new medicine for […] August 24, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 22 Aug 2022 Drug to treat rare kidney disease to be reviewed by EMA The European Medicines Agency (EMA) has agreed to review a conditional marketing authorization (CMA) application for a drug to treat a rare kidney disorder. The news was announced today (August 21) by CSL Vifor and Travere Therapeutics Inc, and, if approved, the companies say sparsentan will address a significant unmet need in treating IgA nephropathy […] August 22, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 19 Aug 2022 Aeglea BioTherapeutics’ arginine 1 deficiency treatment gets EMA ok Aeglea BioTherapeutics, Inc. says its marketing authorization application (MAA) for pegzilarginase for the treatment of arginase 1 deficiency (ARG1-D) has been validated by the European Medicines Agency (EMA). The MAA was submitted by Immedica Pharma AB, Aeglea’s commercialization partner in Europe and the Middle East. Pegzilarginase is a novel, recombinant human arginase 1 enzyme that […] August 19, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 28 Jul 2022 Biogen’s New Drug Application for first treatment of rare form of neurological disease accepted by FDA A drug to target a rare genetic form of a neurological disease that affects the nerve cells, leading to the loss of everyday functions, could be the first of its kind available if approved. The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) from Massachusetts-based Biogen Inc. for tofersen, an […] July 28, 2022 - 4 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
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 Share WhatsApp Twitter Linkedin Email
News and Trends 27 Jun 2022 Covid vaccine granted marketing authorization in Europe Specialty vaccine company, Valneva, has been given marketing authorization in Europe for its inactivated whole-virus COVID-19 vaccine VLA2001. This is a turnaround from the company’s situation in May of this year when the stock price was knocked down by 20% when gaining traction in the EU was proving to be a struggle. Despite authorization from […] June 27, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 20 Apr 2022 Valneva’s Covid-19 Vaccine Reaches UK Market with EU In Sights A Covid-19 vaccine developed by the French company Valneva has received the green light from the UK’s drug regulator. The EMA, meanwhile, is proving harder to convince. The UK’s relationship with the French vaccine developer Valneva has run hot and cold over the past two years. In 2020, the UK government invested in Valneva’s manufacturing […] April 20, 2022 - 4 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
In Depth 13 Apr 2022 Cultured Meat Is Coming Soon: Here’s What You Need to Know Cultured meat promises to change the way we eat and help solve some of the big problems of a crowded planet. When will it be on our plate and how will this technology impact the world? In a couple of years, your food might be served with meat that has been grown from animal cells […] April 13, 2022 - 12 minutesmins - By Clara Rodríguez Fernández Share WhatsApp Twitter Linkedin Email
Best in Biotech 22 Dec 2021 The Biggest European Biotech News of 2021 In spite of the challenges posed by the Covid-19 pandemic, the European biotech industry has emerged stronger than ever this year. These were the key moments for the sector in 2021. The year 2021 has seen skyrocketing fortunes for many European biotech players. Investment firms, for instance, raised far more funding than in 2020, which […] December 22, 2021 - 10 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 21 Dec 2021 Argenx’s Potential Blockbuster Gets FDA Nod for Autoimmune Disease US regulators have approved the first-in-class drug efgartigimod for the treatment of the rare muscle disease generalized myasthenia gravis, opening up its developer argenx to billion-dollar revenues. Efgartigimod, to be marketed as Vyvgart, is an antibody fragment drug for use in adults with generalized myasthenia gravis. The FDA’s decision represents the first successful drug approval […] December 21, 2021 - 4 minutesmins - By Anita Chakraverty Share WhatsApp Twitter Linkedin Email