Press Releases

Taysha Gene Therapies, a patient-centric gene therapy company with a mission to eradicate monogenic CNS diseases, announced that it has received Orphan Drug Designation and Rare Pediatric Disease Designation from the U.S. Food and Drug Administration (FDA) for TSHA-101, an AAV9-based gene therapy in development for GM2 Gangliosidosis. The company anticipates TSHA-101 to enter the clinic by the end of 2020. “Receiving both Orphan Drug Designation and Rare Pediatric Disease Desi

Reign Resources Corporation and Sigyn Therapeutics, Inc. (“Sigyn”), a privately held medical technology company focused on the treatment of life-threatening inflammatory conditions, announced that the companies have entered into a definitive merger agreement pursuant to which Reign will acquire all of the outstanding capital stock of Sigyn in exchange for shares of Reign common stock representing approximately 75 percent of Reign’s outstanding common stock. Upon completion o

OncoBay Clinical, Inc., a full-service boutique contract research organization (CRO) specializing in complex oncology programs including cellular therapy, and Vineti, a company that offers a digital platform to enable broad access to advanced therapeutics, today announced a fully integrated solution to provide advanced therapy developers with a complete suite of clinical trial systems and services. Today, many processes and workflows for cell and gene therapy clinical trials are man

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced it has signed two agreements in Hainan, China with PT Bio Farma, a leading biopharmaceutical company in Indonesia, for the supply, local production and technology licensing in respect of the CoronaVac, Sinovac’s inactivated vaccine candidate against COVID-19. The Minister of Foreign Affairs of Indonesia, H.E. Retno LP Marsudi and Minister of State Owned-Companies of Indonesia, H.E. Erick Thohir wi

PharmaSources.com, the vertical B2B portal for the pharmaceutical industry, announces the launch of the virtual session CPhI China Top API Exporters & Products on 24-28 August 2020, as part of the CPhI & P-MEC China E-Trade Season (August to October 2020). The active pharmaceutical ingredients (API) industry in China plays a pivotal role in the global pharmaceutical ecosystem. In 2019, the Chinese API manufacturers produced and exported to the world 10.12 million tons of pro

PharmaSources, an international B2B trade portal for the pharmaceutical verticals, is launching the virtual event CPhI & P-MEC China E-Trade Season from August to December 2020. Consisting of the three sessions "Top API Exporters & Products", "Popular Natural Extracts for Health and Pharma" and "P-MEC China Webinar: Russia Pharmaceutical Manufacturing and Machinery", the E-Trade Season is to facilitate digital sourcing solutions, learning opportunities an

Eisai Co., Ltd. announced today that it has launched Sahne Medical Spray and Sahne Medical Cream (both are category-2 OTC drugs, "Sahne Medical") on August 25, 2020 at pharmacies and drugstores throughout Japan, as a new product of the Sahne brand lineup which has been a favored hand care for generations. Eisai conducted a survey of 1,000 women in their 40s to 50s in April 2020. As a result, it was found that approximately 70% of the subjects felt that the dryness of their

Catalent, Inc., the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that Catalent Cell & Gene Therapy will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland.

Researchers have modified a derivative of a plant toxin and linked it to a nanocarrier to create a powerful new therapeutic for childhood tumors.  The new drug and its ability to eliminate chemoresistant tumors in mice is described in a new study published in Cancer Research, a journal of the American Association for Cancer Research.  An exclusive license to develop the drug has been obtained by PEEL Therapeutics, Inc.     Scientists from Children's Hospital

Audentes Therapeutics, Inc., an Astellas company,  announced that a third study patient has passed away in the ASPIRO clinical trial evaluating AT132 in patients with X-linked Myotubular Myopathy (XLMTM), which is a serious, life-threatening neuromuscular disease characterized by extreme muscle weakness, respiratory failure, and early death. Preliminary findings indicate that the immediate cause of death was gastrointestinal bleeding. This patient was one of three study patient