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 30 Aug 2022 Hemophilia drug from Sanofi and Sobi has license application accepted for priority review by FDA The Biologics License Application (BLA) for Efanesoctocog alfa, a drug to treat the rare and life-threatening blood disease, hemophilia A, has been accepted for priority review by the U.S. Food and Drug Administration (FDA). Efanesoctocog alfa (BIVV001) is being developed and commercialized as part of a collaboration between Sanofi and Sobi was given the target […] August 30, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 25 Aug 2022 Hope for children with chronic graft versus host disease as Johnson & Johnson drug approved A treatment for chronic graft versus host disease in children aged one year and older has been approved by the U.S. Food and Drug Administration (FDA). Graft versus host disease is a common complication after receiving a donor stem-cell or bone marrow transplantation. Sometimes, the graft doesn’t recognize the host as being friendly and sees the […] August 25, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 23 Aug 2022 Ocelot Bio receives FDA Orphan Drug Designation for lead candidate for treatment of hepatorenal syndrome Ocelot Bio, Inc., a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead candidate OCE-205 for the treatment of hepatorenal syndrome. Ocelot Bio is currently enrolling patients in a phase 2 clinical trial of OCE-205 in hepatorenal syndrome with acute kidney injury (HRS-AKI), […] August 23, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 22 Aug 2022 Ascletis is first Chinese biotech company to get IND approvals for oral RdRp inhibitor An investigational new drug (IND) application for a COVID-19 treatment has been approved by the China National Medical Products Administration (NMPA). The application is for ASC10, an oral inhibitor drug candidate targeting RNA-dependent RNA polymerase (RdRp) that targets the COVID-19 virus. China’s first Ascletis is China’s first biotech company to obtain IND approvals of an […] August 22, 2022 - 2 minutesmins - By Liza Laws 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 19 Aug 2022 Axsome Therapeutics’ MDD treatment gets green light from FDA The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics, Inc.’s Auvelity tablets for the treatment of major depressive disorder (MDD) in adults. Auvelity (dextromethorphan HBr -bupropion HCl) is the first and only rapid-acting oral medicine approved for the treatment of MDD with labeling of statistically significant antidepressant efficacy compared to placebo starting at […] August 19, 2022 - 4 minutesmins - By Jim Cornall 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 Patients with beta-thalassemia able to access first approved gene therapy A gene therapy drug approved by the U.S. Food and Drug Administration (FDA) has been made accessible for people with beta-thalassemia. Zynteglo, a betibeglogene autoemcel, also known as beti-cel, treats adults and pediatric patients with the disease who need regular red blood (RBC) transfusions. The condition is passed down from one or both parents through […] August 18, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 12 Aug 2022 Tetro Bio-Pharma enters subscription agreement following advice from Alpha Blue Ocean Tetra Bio-Pharma Inc., a company working in cannabinoid-based drug discovery and development, has announced it has entered into a subscription agreement with investment vehicle Global Corporate Finance Opportunities 16 (GCFO 16). The announcement came yesterday (August 11) after Alpha Blue Ocean (ABO) advised the partnership whereby Canadian-based Tetra agrees to issue investor GCFO 16 senior […] August 12, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 11 Aug 2022 First patient enrolled on Panbela’s trial for treatment of pancreatic cancer Panbela Therapeutics, a U.S.-based clinical stage company, announced today (August 11) that it has enrolled its first patient in a global trial to evaluate a potential cure for pancreatic cancer. The trial referred to as ASPIRE will involve studying SBP-101, a treatment for metastatic pancreatic ductal adenocarcinoma. It is a randomized, double-blind placebo-controlled, trial with […] August 11, 2022 - 3 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email