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
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 19 Aug 2022Beyond Biotech podcast 10: Endpoint Health, Nevrargenics, Triastek This week our guests on the podcast are Xianghao Zuo, deputy director of R&D at Triastek; Endpoint Health CEO Jason Springs; and Andy Whiting, CEO of Nevrargenics. Triastek and Lilly working together on 3D printing for drugs A new research collaboration between Chinese company Triastek, Inc. and Eli Lilly and Company will leverage 3D printing […] August 19, 2022 Share WhatsApp Twitter Linkedin Email
News and Trends 19 Aug 2022 Aeglea BioTherapeutics’ arginine 1 deficiency treatment gets EMA ok Aeglea BioTherapeutics, Inc. says its marketing authorization application (MAA) for pegzilarginase for the treatment of arginase 1 deficiency (ARG1-D) has been validated by the European Medicines Agency (EMA). The MAA was submitted by Immedica Pharma AB, Aeglea’s commercialization partner in Europe and the Middle East. Pegzilarginase is a novel, recombinant human arginase 1 enzyme that […] August 19, 2022 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
Best in Biotech 19 Aug 2022 Five emerging biotech hubs in the Asia-Pacific region The Asia-Pacific (APAC) region is the third largest pharmaceutical market in the world, and has seen a shift from predominantly producing generics to developing innovative technologies. Here are five emerging biotech hubs in the region to keep an eye on. The life sciences industry is seeing rapid growth in the APAC region – home to […] August 19, 2022 - 7 minutesmins - By Omnia Ibrahim 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
In Depth 18 Aug 2022 How technology transfer offices can navigate biotech commercialization Technology transfer offices are vital departments for commercializing an academic’s biotech innovations, yet they can also be resource-stretched and averse to risk. Here are some ways they can streamline their process and land more deals with investors and big pharma. Technology transfer offices (TTOs) perform vital functions in universities by guiding academics through the process […] August 18, 2022 - 8 minutesmins - By Jonathan Smith 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