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Bristol-Myers Squibb’s Late-Stage Study of Opdivo in Lung Cancer Stopped Early

Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) met its primary endpoint in a late-stage lung cancer trial, resulting in an early of the study. The company said that its Phase III study evaluating Opdivo versus docetaxel in previously treated patients with advanced non-squamous non-small cell lung cancer (NSCLC) was stopped early because …

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Researchers Develop New Drug Candidate that Shows Potential in Treating Rare Leukemia

University of Michigan Comprehensive Cancer Center researchers have developed a new potential drug candidate that shows promise against a rare type of blood cancer, as well as potential in prostate cancer. The new drug candidate showed potential in laboratory studies against a rare type of acute leukemia. Additionally, separate studies …

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FDA Issues Warning of Life-Threatening Effect When Combining A Heart Drug with New Hepatitis C Drugs

The US Food and Drug Administration (FDA) issued a warning about the risk of potentially life-threatening slowing of the heart rate that can occur when a common heart drug is taken with new hepatitis C medications. The agency said that this complication can occur when the antiarrhythmic drug amiodarone is …

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FDA Grants Orphan Drug Designation to Aduro’s Mesothelioma Candidate

Today, Aduro Biotech Inc. announced that US health regulators have granted Orphan Drug designation to its novel, immuno-oncology candidate. The company said that the Office of Orphan Product Development of the US Food and Drug Administration (FDA) granted orphan drug designation to CRS-207, Aduro’s novel immuno-oncology product candidate in development …

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Lilly Partners with Hanmi for Autoimmune Disorder Drug

Eli Lilly and Company is shelling out up to $690 million for access to Hanmi Pharmaceutical’s Phase I compound HM71224, in development for autoimmune diseases. The companies announced today that they have entered into an exclusive license and collaboration agreement for the development and commercialization of Hanmi’s oral Bruton’s tyrosine …

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Myriad Expands Collaboration with BioMarin for Cancer Companion Diagnostic Test

Myriad Genetics recently announced that it has expanded its collaboration with BioMarin Pharmaceutical to use Myriad’s myChoice HRD companion diagnostic test. Under the deal, BioMarin will use Myriad’s myChoice HRD companion diagnostic test to prospectively identify patients with metastatic breast, ovarian and potentially other tumor types that may be sensitive …

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Nektar’s Breast Cancer Drug Fails its Late-Stage Trial

Nektar Therapeutics’ experimental breast cancer drug, and key to the company’s future growth, failed a late-stage study. The company said that its NKTR-102 failed to meet its primary endpoint in the Phase III BEACON study. The drug is considered key to the Nektar’s future growth. The company’s CEO Howard Robin …

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FDA Grants Orphan Drug Designation to Selten Pharma’s Pulmonary Arterial Hypertension Candidate

Today, privately-held, rare disease focused Selten Pharma, Inc. announced that US health regulators granted its investigational pulmonary arterial hypertension (PAH) drug orphan drug designation. The company said that its lead compound tacrolimus (SPI-026) has been granted orphan drug designation (ODD) by the US Food and Drug Administration (FDA) for the …

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