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 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 23 Aug 2022 Institute for Bioscience and Biotechnology Research awarded $6.9M to work on hepatitis C vaccine The National Institute of Allergy and Infectious Disease (NIAID) has awarded a $6.9 million grant to researchers at the Institute for Bioscience and Biotechnology Research (IBBR) to design a vaccine to combat the virus that causes hepatitis C. Hepatitis C is an illness that affects an estimated 71 million people worldwide. Hepatitis C Virus (HCV) […] August 23, 2022 - 2 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
Interview 22 Aug 2022 Hiring practices are shifting as biotech goes digital Cloud computing is becoming increasingly prevalent as demand for global collaborations grows. Sajith Wickramasekara, founder and CEO of the cloud lab software provider Benchling, explains how this shift is affecting the labor market in the biotech industry. The biotech industry is becoming increasingly enmeshed with the world of digital technology, as companies search for ways […] August 22, 2022 - 5 minutesmins - By Jonathan Smith Share WhatsApp Twitter Linkedin Email
News and Trends 22 Aug 2022 EpiVario looks to biotech for PTSD treatment Emerging U.S. biotech company EpiVario, Inc. has highlighted preclinical research findings that could lead to a treatment approach for post-traumatic stress disorder (PTSD). Published in Proceedings of the National Academy of Sciences (PNAS), and co-authored by the academic co-founders of EpiVario, the study demonstrates that fear memories can be controlled through the enzyme acetyl-CoA synthetase […] August 22, 2022 - 4 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 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 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
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