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 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 Gilead to acquire remaining worldwide rights of breast cancer drug, Trodelvy All of Everest Medicine’s development and commercialization rights for a breast cancer drug called Trodelvy have been transferred to American biopharma Gilead Sciences Inc. The transfer of the antibody drug, sacituzumab govitecan treatment, will apply to Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. In China mainland and Singapore, Trodelvy is […] August 19, 2022 - 3 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 19 Aug 2022 Nuance Pharma receives clearance to begin clinical trials with Ensifentrine in China Nuance Pharma and its partner Verona Pharma plc have received clearance from the Center of Drug Evaluation for the investigational new drug (IND) application for ensifentrine. The application means both phase 1 and phase 2 studies looking at the drug for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in mainland China. In 2021, […] August 19, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 18 Aug 2022 First patient on Innovative Cellular Therapeutics’ study looking at treating colorectal cancer The first patient has been enrolled on a study to trial a treatment for relapsed or refractory metastatic colorectal cancer (R/R mCRC) in the U.S. Innovative Cellular Therapeutics (ICT), Inc. a clinical-stage biotechnology company developing a comprehensive portfolio of chimeric antigen receptor (CAR) T cell therapies made the announcement today (August 18). Tolerability The study […] August 18, 2022 - 2 minutesmins - By Liza Laws 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 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
More News! 18 Aug 2022 Collaboration to advance investigational tuberculosis drug treatments A collaboration called The Project to Accelerate New Treatments for Tuberculosis (PAN-TB) was announced yesterday (August 17). The joint development agreement (JDA) will support the progression of two investigational tuberculosis (TB) combination treatment regimens into phase 2 clinical development. The collaboration is made up of organizations contributing five antimicrobial agents. Active pulmonary TB Together they […] August 18, 2022 - 5 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 17 Aug 2022 Palisade Bio announces closing of $13.8M upsized underwritten public offering A biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications has announced today (August 17) the closing of its previously announced underwritten public offering for $13.8 million. An underwritten public offering means a public offering in which the common stock is offered and sold on a firm commitment basis through one or more underwriters. […] August 17, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email
News and Trends 17 Aug 2022 Researchers invited to apply for DNA synthesized by Evonetix’s platform An early access program for semiconductor synthesized DNA has been opened by UK-based gene synthetic biology company, Evonetix. Evonetix’s DNA synthesis capability brings together semiconductor chip design and proprietary, thermally controlled synthesis chemistry, integral to the company’s future gene synthesis platforms. Silicon chip The company’s proprietary process utilizes a silicon chip to control the synthesis […] August 17, 2022 - 2 minutesmins - By Liza Laws Share WhatsApp Twitter Linkedin Email