Press Releases

Cybeats Technologies Corp. is pleased to announce a new software licence agreement with a top 3 global medical device and diagnostics leader, for Cybeats' SBOM Studio1, to manage their Software Bill of Materials (SBOM) and support regulatory compliance requirements with looming FDA mandates on SBOM adoption for medical device manufacturers.2 "Signing one of the largest organizations in the medical device industry is important validation of the value of SBOM Studio for the h

Astellas Pharma Inc. today announced that the U.S. Food and Drug Administration has lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease. "With that same spirit and focus on patient safety, we look forward to resuming the FORTIS clinical trial and the continued development of AT845 as an important potential new treatment for adults living wit

Neochromosome, Inc., a wholly owned subsidiary of Opentrons Labworks, Inc., focused on changing the world of biologics through genome-scale cell engineering, has announced a collaboration with Sumitovant Biopharma Inc., a technology-driven biopharmaceutical company accelerating the development and commercialization of novel therapeutics. This collaboration combines Neochromosome’s neoYeast™ platform with Sumitovant’s DrugOME™ computational ecosystem to identify novel p

Virpax Pharmaceuticals, Inc.a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, and central nervous system disorders, today announced that it will utilize leading pain expert, Dr. Neil K. Singla, to assist in the design and support of the clinical development strategy for Probudur. Probudur is Virpax’s post-operative, ultra-long-acting anesthetic injection product candidate for post-operative pain management that is

CANbridge Pharmaceuticals, Inc. a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, announced that the first patient has been dosed in the Phase 2 part of the ongoing CAN103 Phase 1/2 trial in treatment-naïve patients with Gaucher disease (GD) Types I and III in China. Bing Han MD, PhD, Chief Physician and Professor in the Department o

Hataali – the advanced therapy ecosystem platform – has announced the launch of Hataali 2.0. This second-generation platform will unlock the potential in the advanced therapies ecosystem by providing a plug and play approach for any stakeholder and almost any type of data. Hataali, which was originally developed as a blockchain-based system to track advanced therapies from vein to vein, now offers a single holistic platform for all parts of the advanced therapy ecosystem

Sai Life Sciences, one of India's fastest growing Contract Research, Development and  Manufacturing companies, today announced the opening of a new Manufacturing Facility for High Potency Active Pharmaceutical Ingredients at its cGMP API campus manufacturing facility in Bidar, India. With this new facility, the company expands its expertise in the development and manufacture of highly effective pharmaceutical ingredients and offers its customers an optimized path for the development

QIAGEN today announced the launch of EZ2 Connect MDx for use in diagnostic laboratories, making the IVD platform for automated sample processing available for widescale use 18 months after being made available for research. With a high degree of automation, the EZ2 Connect MDx enables labs to purify DNA and RNA from 24 samples in parallel in as little as 30 minutes1. The device now carries the EU’s CE-IVD compliance marking for in-vitro devices (IVD) for the European Union and ot

OBiO Technology a gene and cell therapy-focused contract research organization and contract development and manufacturing organization, recently announced that the United States Food and Drug Administration has accepted its GMP plasmid DNA drug master file, DMF Number 037766. The DMF acceptance enables a direct reference for investigational new drug (IND) filing for lentiviral vectors, autologous cell therapy, allogeneic cell therapy and stem cell therapy products, and helps shorten the commu

Ascletis Pharma Inc.today announces that its wholly owned subsidiary Ascletis Pharmaceuticals Co., Ltd. has entered into a supply agreement of ritonavir tablets with Hainan Simcere Pharmaceutical Co., Ltd., a subsidiary of Simcere Pharmaceutical Group Limited. Ritonavir tablet is a pharmacokinetic booster of multiple oral antiviral protease inhibitors. Ascletis currently owns the only authorized ritonavir oral tablet in China, which has passed bioequivalence study.