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 BioInnovation Institute supports three start-ups The BioInnovation Institute (BII), an international commercial non-profit foundation incubating and accelerating life science research, has invested in three international start-up companies in the U.K., Germany, and Finland. The three new ventures are strategically aligned with the BII’s focus, developing ground-breaking scientific initiatives across the therapeutics and health tech space. Each company will be funded […] August 22, 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 Roche launches COVID-19 test to detect emerging variant of interest Roche and its subsidiary TIB Molbiol have developed a COVID-19 test for researchers that detects and differentiates the latest sub-variant of interest BA.2.75. The test specifically targets two of the known unique mutations in BA.2.75, which allows clear differentiation against other notable subvariants. “Roche is pleased to have developed a test for researchers that provides […] August 22, 2022 - 2 minutesmins - By Jim Cornall 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 Emtora to use $16.9M grant to develop treatment for rare genetic disease Emtora Biosciences, a Texas-based clinical-stage biopharmaceutical company, has been awarded a $16.9 million non-dilutive grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The funding will be used to advance the clinical and product development of its lead program, eRapa, an encapsulated form of rapamycin, for the treatment of familial adenomatous polyposis (FAP). […] August 19, 2022 - 2 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 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 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
Interview 19 Aug 2022 How re-engineering antibodies can prevent allergies The California startup IgGenix is aiming to re-engineer antibodies that mediate allergic responses into antibodies that can block this response. We spoke with IgGenix’s CEO Jessica Grossman and CTO Derek Croote to understand the potential of such a therapy. Allergies are overreactions of the immune system to foreign substances that are normally harmless. Worldwide, and […] August 19, 2022 - 9 minutesmins - By Omnia Ibrahim Share WhatsApp Twitter Linkedin Email
Interview 19 Aug 2022 Delaying menopause could slow the aging process After decades of neglect, women’s health is attracting increasing interest in the biotech industry. The U.S. startup Oviva Therapeutics aims to develop hormonal therapies that can delay menopause as part of the aging process. Many biotech companies fighting aging are attracting massive cash infusions. One well-known example is Altos Labs, which launched in Silicon Valley […] August 19, 2022 - 6 minutesmins - By Jonathan Smith 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