Press Releases

Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair, and targeted immuno-oncology, announced today that the US Food and Drug Administration (FDA) has approved an expansion to its Phase I/II clinical program, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the US. The OASIS trial was approved by the FDA earlier this year to assess the sa

Jim Huang, Ph.D., founder and CEO of Ascendia Pharmaceuticals, announces that the pharmaceutical contract development and manufacturing organization (CDMO) has re-branded to Ascendia Pharmaceutical Solutions. The new name and brand reflect Ascendia's many successes and growth over the past 13 years, as the CDMO continues to provide solutions and expand its services from early formulation development to GMP manufacturing and commercialization. "Over the past 13 years we have

Carisma Therapeutics Inc. a leader in macrophage-focused therapeutics, today announced a strategic reprioritization of its pipeline, cessation of development of CT-0525, and a reduction in the workforce by 34%. These measures will enable Carisma to focus its resources on advancing its in vivo macrophage engineering platform for the development of fibrosis, oncology and autoimmune disease therapies. This decision aligns Carisma's efforts with next-generation, high-potential programs addres

IDEAYA Biosciences, Inc. a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced development candidate nomination of IDE892, a potential best-in-class MTA-cooperative PMRT5 inhibitor. "We continue to expand our precision medicine oncology pipeline and are excited to nominate our 7th development candidate in IDE892, a potential best-in-class MTA-cooperative PMRT5 inhibitor. IDE892 advances our strategic objective

Janssen-Cilag International NV, a Johnson & Johnson company, today announced new frontline data featuring TECVAYLI®▼ (teclistamab) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) in induction and maintenance settings.1,2 The MajesTEC-5 (Abstract #493) and MajesTEC-4 (Abstract #494) studies establish the potential of teclistamab for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile.1,2 These data were hig

Theriva™ Biologics a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the outcomes of a recent Type D meeting with the U.S. Food and Drug Administration (FDA) to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC). The Company rec

Valisure and Picket Pharmaceuticals have announced a strategic partnership to integrate Valisure's independent chemical analysis and certification program into Picket Pharmaceuticals' injectable drug product offerings. This collaboration aims to help address the primary market failure of generic drugs where a lack of transparency to quality combined with "race to the bottom" pricing has led to record levels of drug shortages in the United States. Public health is i

Eli Lilly and Company today announced a $3 billion expansion of the Kenosha County, Wisconsin, manufacturing facility that the company acquired earlier this year. This investment will extend the company's global parenteral (injectable) product manufacturing network, helping to meet the growing demand for its diabetes, obesity and future pipeline medicines across therapeutic areas. Lilly expects to add 750 highly skilled jobs to the current 100-plus workforce at this location. Th

Jazz Pharmaceuticals plc today announced that zanidatamab-hrii (Ziihera®) 50 mg/mL for injection for intravenous use is recommended by the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a category 2A treatment option for Biliary Tract Cancers (BTC). Ziihera was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on November 20, 2024, for the treatment of adults with previously

Salipro Biotech AB, a Swedish biotechnology company focused on advancing drug discovery for challenging drug targets, today announced the issuance of granted patents in both Singapore and Australia for its  Salipro® platform technology, a novel and proprietary method for directly isolating and purifying native membrane proteins, which are important targets for many therapeutic drugs. The Salipro® platform enables entirely novel drug discovery programs, including antibody discover