The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig® (ponatinib; Takeda) for adults with chronic-phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least 2 prior kinase inhibitors. The sNDA approval is based on efficacy and safety data from the open-label...
Latest News
Tokyo, Japan and Basking Ridge, NJ – The first patient has been dosed in the IDeate-Esophageal01 Phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator’s choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following...
SOUTH SAN FRANCISCO, Calif. — IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the US and Canada) to evaluate IDE161,...
SOUTH SAN FRANCISCO, Calif. – IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality-focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced dose expansion of the ongoing Phase 1/2 study (ClinicalTrials.gov Identifier: NCT03947385) evaluating the combination of IDE196 and binimetinib in metastatic uveal melanoma (MUM). ...
SOUTH SAN FRANCISCO, Calif. — IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced the initiation of a Phase 1/2 expansion in the clinical trial evaluating IDE397, its investigational, potential first-in-class, small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, in combination...
PARMA, Italy and BOSTON, Mass. — Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people living with rare diseases, today announced the US Food and Drug Administration (FDA) is evaluating the regulatory submission of idebenone to treat Leber Hereditary...
Baltimore, Maryland – Repeats of DNA sequences, often referred to as “junk DNA” or “dark matter,” that are found in chromosomes and could contribute to cancer or other diseases have been challenging to identify and characterize. Now, investigators at the Johns Hopkins Kimmel Cancer Center have developed a novel approach that uses...
GUANGZHOU, China — Bio-Thera Solutions, Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the Independent Data Monitoring Committee (IDMC) has recommended early study termination for the pivotal Phase II/III trial of BAT4406F in neuromyelitis optica spectrum disorder (NMOSD) based on positive...
Rio de Janeiro, Brazil – D’Or Institute for Research and Education (IDOR) played an important role in the phase III LIBRETTO-431 multicenter study, which evaluated the efficacy and safety of selpercatinib compared to control treatment, which consisted of platinum-based chemotherapy associated or not with pembrolizumab (immune checkpoint inhibitor) in non-small...
PHILADELPHIA – iECURE, a mutation-agnostic in vivo gene editing company striving to cure devastating diseases with high unmet need, today announced it has appointed Brian Di Donato, MBA to its Board of Directors. Mr. Di Donato has more than 20 years of financial and leadership experience and currently serves as...