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 25 Aug 2022 Alpha Biopharma announces completion of phase 2/3 clinical study for drug to treat lung cancer Patients with advanced EGFRm+ non-small cell lung cancer (NSCLC) with central nervous system (CNS) metastases have completed their last visit in a clinical trial studying the drug, Zorifertinib. Drugs developer, Alpha Biopharma, announced the completion today (August 25) of last patient last visit (LPLV) in its international, multicenter EVEREST phase 2/3 study of the next-generation […] August 25, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 24 Aug 2022 Clearance given to clinical trial with potential to change course of brain disease A trial to look at gene therapy, BV-01, for Huntington’s Disease has been given the go ahead to take place in France and has ‘the potential to change the course of the devastating disease. Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, received clearance for the phase 1/2 […] August 24, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 24 Aug 2022 Oncolyze seeking investment for AML clinical trials After successfully completing in vitro and in vivo experiments, which support the notion that its lead drug candidate OM-301 breaks down cancer cells and increases survival rates, Oncolyze now has its sights set on advancing OM-301 into clinical trials. Oncolyze has launched a Regulation A+ funding campaign to spread awareness of OM-301 among cancer patients, […] August 24, 2022 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 23 Aug 2022 180 Life Sciences announce enrollment of the first patient in frozen shoulder treatment trial The first patient has been enrolled on a clinical trial to evaluate anti-tumor necrosis factor for patients with early-stage, pain predominant frozen shoulder. 180 Life Sciences, a clinical-stage biotechnology company made the announcement yesterday (August 22). James Woody chief executive officer of 180 Life Sciences, said: “Recruiting the first patient for the trial of anti-TNF […] August 23, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 23 Aug 2022 Alume Biosciences progressing with fluorescence study in patients undergoing head and neck surgery Alume Biosciences, Inc. says the first patient has been dosed in a phase 3 pivotal study of ALM-488, a peptide-dye conjugate designed to highlight nerves with fluorescence in real time during surgery. “The successful initiation of this phase 3 pivotal study is another major milestone for Alume Biosciences. It marks the final phase of clinical […] August 23, 2022 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 22 Aug 2022 Santhera and ReveraGen announce first patient with Becker muscular dystrophy dosed in FDA-funded pilot study The first patient has been dosed in a phase 2 pilot study looking at a treatment for muscular dystrophy. Santhera Pharmaceuticals and ReveraGen BioPharma made the announcement that vamorolone is to be assessed in patients with Becker muscular dystrophy (BMD). The study is being funded by the U.S. Food and Drug Administration (FDA). Eric Hoffman, […] August 22, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 22 Aug 2022 Vaderis emerges from stealth to start HTT trial Vaderis Therapeutics AG, a clinical stage biotech company focused on developing treatments for rare diseases associated with vascular malformations, has emerged from stealth. The company has also started its INSIGHT proof-of-concept clinical trial in patients suffering from hereditary hemorrhagic telangiectasia (HHT), also known as Osler-Weber-Rendu syndrome. About HHT HHT is a disorder where some blood […] August 22, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 19 Aug 2022 World’s first CAR-T for treatment of inflammatory disorders of the central nervous system approved in China China’s National Medical Products (NMPA) has approved an investigational new drug application from IASO Bio for the new extended indication of neuromyelitis optica spectrum disorder (NMOSD). Neuromyelitis optica spectrum disorders previously known as Devic disease or neuromyelitis optica are inflammatory disorders of the central nervous system characterized by severe, immune-mediated demyelination and axonal damage predominantly targeting […] August 19, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 19 Aug 2022 Treatment for patients with fragile skin disease accepted by FDA The U.S. Food and Drug Administration (FDA) has accepted the filing of a biologic license application (BLA) for B-VEC, a treatment for patients with dystrophic epidermolysis bullosa (DEB). Krystal Biotech Inc. works in redosable gene therapy and made the announcement today (August 18). The application has been granted Priority Review designation, and the Prescription Drug […] August 19, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 18 Aug 2022 FDA lifts partial clinical hold on Curis lymphoma study Curis, Inc., a biotech company focused on the development of innovative therapeutics for the treatment of cancer, says the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the TakeAim lymphoma phase 1/2 study of emavusertib after reviewing the data package submitted by Curis. “We are excited to announce that FDA […] August 18, 2022 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 18 Aug 2022 CSL gets positive results for preventive treatment in patients with hereditary angioedema Hereditary angioedema (HAE), a condition that causes recurrent attacks of severe swelling, could be prevented by a monoclonal antibody after positive top line phase 3 results were reported. Garadacimab, biotech company CSL’s investigational monoclonal antibody inhibiting factor XIIa, is being developed as a long-term preventive treatment for patients with HAE. Efficacy objectives The study met […] August 18, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email