Press Releases

China Oncology Focus Limited (COF), an affiliate of Lee's Pharmaceutical Holdings Limited (Lee's Pharm, HKEX: 950) announced that its anti-PD-L1 antibody, Socazolimab, licensed from Sorrento to COF for the greater China territory, has been cleared to begin a multicenter, randomized, double blinded, parallel-group clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell

Hyloris Pharmaceuticals SA, a specialty biopharma company committed to bringing innovative treatments that offer added value to underserved patient populations, announces that its partner AFT Pharmaceuticals (“AFT”) has signed an exclusive licensing agreement with Aguettant for Maxigesic IV, a novel, dual mode-of-action non-opioid pain treatment delivered through intravenous (IV) infusion, in eight European markets. The agreement with Aguettant means that Maxigesic IV is

Sharp, part of UDG Healthcare plc, a global leader in contract packaging and clinical supply services, has appointed Ria Rhemrev-Boom as its new lead EU Qualified Person (QP) for market release services. In her new role, Ria will take responsibility for leading Sharp’s QP release to market services for its customers, ensuring the medicines manufactured, packaged and handled throughout the supply chain comply with EU GMP rules and all applicable regulatory standards.

Luminex Corporation announced that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a new expanded version of its NxTAG® Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing. The new test is a combination of the company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and SARS-CoV-2. Respiratory infections such as C

Foresee Pharmaceuticals announced that it has entered into an exclusive license agreement with Intas Pharmaceuticals ("Intas") for the US commercialization of Foresee's novel FP-001 program, Leuprolide Mesylate Injectable Suspension (LMIS) ready-to-use subcutaneous 6-month and 3-month depot formulations ("Camcevi®"). The application for the 3-month indication of Camcevi® has not yet been filed with the US Food and Drug Administration (FDA) and is under developm

Dialectic Therapeutics, Inc. (Dialectic®), a Texas-based biotechnology company focused on creating innovative new technologies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) has concluded that Dialectic may proceed with its clinical investigation for its lead product candidate, DT2216, a unique compound built using its proprietary and novel Antiapoptotic Protein Targeted Degradation (APTaD™) technology. In pre-clinical studies supported through a S

Takeda Pharmaceutical Company Limited and Ovid Therapeutics Inc., a biopharmaceutical company committed to developing medicines that transform the lives of people with rare neurological diseases, announced that Takeda has entered into an exclusive agreement under which Takeda will secure global rights at closing from Ovid to develop and commercialize the investigational medicine soticlestat (TAK-935/OV935) for the treatment of developmental and epileptic encephalopathies, including Dravet syn

Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, announced their collaboration with Immunitas Therapeutics, Inc. (www.immunitastx.com) for the development of a systems pharmacology model for an oncology pathway with complex receptor-ligand dynamics. The model will be used to understand the importance of targeting multiple receptors simultaneously and will

Innoforce, a biopharmaceutical innovation enabling platform and PDMO (Partner Development and Manufacturing Organization), and dMed, a clinical CRO with strong presence in China and the US - the world's two largest pharmaceutical and drug development markets, have signed an agreement under which the two parties agreed to establish a partnership to identify, assess, and collaborate on the development of clinical-stage therapeutics. Dr. Lingshi Tan, founder and CEO of dMed said, &

Chinook Therapeutics, Inc. and Evotec SE announced a strategic collaboration focused on the discovery and development of novel precision medicine therapies for patients with chronic kidney diseases. Based on Evotec’s proprietary comprehensive molecular datasets from thousands of patients across chronic kidney diseases of multiple underlying etiologies, Chinook and Evotec will jointly identify, characterize and validate novel mechanisms and discover precision medicines for PKD, lupus nep