Phanes Therapeutics, Inc., a clinical-stage biotechnology company dedicated to advancing oncology treatments, has achieved a significant milestone with the granting of Orphan Drug Designation (ODD) for its novel therapy, PT217. The U.S. Food and Drug Administration (FDA) awarded this status to PT217 for its potential in treating neuroendocrine carcinoma (NEC), a particularly aggressive form of […]
In a significant advancement for cancer treatment, AstraZeneca’s Imfinzi (durvalumab) has emerged as the first and only immunotherapy to show a survival benefit in a global Phase III trial for patients with limited-stage small cell lung cancer (LS-SCLC). The ADRIATIC Phase III trial unveiled positive high-level results, revealing that Imfinzi significantly improved both overall survival […]
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Harpoon Therapeutics, Inc. (Nasdaq: HARP) have entered a definitive agreement where Merck will acquire Harpoon for $23 per share in cash, totaling an approximate equity value of $680 million. This strategic acquisition aims to bolster Merck’s oncology pipeline with Harpoon’s advanced cancer […]
Eli Lilly and Company (NYSE: LLY) has unveiled top-line results from the LIBRETTO-431 study, which focused on the assessment of Retevmo against platinum-based chemotherapy plus pemetrexed in patients diagnosed with RET fusion-positive advanced non-small cell lung cancer (NSCLC). The findings showcased a notable improvement in progression-free survival (PFS), a primary objective of the study. Study […]
AI-driven precision medicine company Exscientia has initiated enrollment for its Phase 1/2 “ELUCIDATE” study, marking the first trial of its precision-designed CDK7 inhibitor, GTAEXS617 (‘617), in the treatment of advanced solid tumours. The trial aims to investigate the safety, efficacy, and pharmacokinetics of GTAEXS617 through multiple ascending doses for patients with advanced solid tumours, including […]
Eagle Pharmaceuticals has secured an additional indication for Pemfexy (pemetrexed injection) in the US, marking the fifth indication for the intravenous medication. Pemfexy in combination with Merck’s Keytruda and platinum chemotherapy has been now approved by the US Food and Drug Administration (FDA) for the initial treatment of patients with metastatic, non-squamous, non-small cell lung […]
Lantern Pharma said that the US Food and Drug Administration (FDA) has authorized it to move ahead with its Harmonic phase 2 clinical trial of LP-300, its investigational new drug in never smokers with non-small cell lung cancer (NSCLC). Harmonic will involve 90 patients in a multi-center, two arm, open-label, and randomized study for assessing […]
Bristol Myers Squibb (BMS) has agreed to acquire Turning Point Therapeutics, a clinical-stage precision oncology company based in California, for $4.1 billion. Listed on the Nasdaq, Turning Point Therapeutics is developing drug candidates that are said to target the highly common mutations related to oncogenesis. Its flagship asset is repotrectinib, which is a tyrosine kinase […]
Genprex has dosed the first patient in the Acclaim-1 phase 1/2 clinical trial of REQORSA immunogene therapy candidate in combination with Tagrisso (osimertinib) in a certain patient population having late-stage non-small cell lung cancer (NSCLC). The combination of REQORSA and Tagrisso is being evaluated in the trial in late-stage NSCLC patients with activating epidermal growth […]
Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The Chinese breakthrough therapy designation for sotorasib is for the treatment of patients having KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer […]