Japanese biopharmaceutical firm Takeda Pharmaceutical announced that the company’s drug candidate for leukemia failed to meet the primary endpoint in a late-stage study.
Dr. Reddy’s Laboratories Ltd. along with the company’s subsidiaries announced that Reddy-Lenalidomide, a generic equivalent to Revlimid (lenalidomide) capsules, was approved by Health Canada and launched in the Canadian market.
The U.S. Food and Drug Administration placed a clinical hold on Boston-based Aprea Therapeutics’ lymphoid malignancy trial after the regulatory agency expressed concerns regarding the safety and efficacy data from a previous myelodysplastic syndromes (MDS) study.
Shares of bluebird bio were down more than 24 percent after the company announced that the U.S. Food and Drug Administration placed a clinical hold on studies of the gene therapy elivaldogene autotemcel (eli-cel) for cerebral adrenoleukodystrophy (CALD).
The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.
Shares of Magenta Therapeutics were down after the company announced the U.S. Food and Drug Administration placed a clinical hold on its clinical program for acute myeloid leukemia and myelodysplastic syndrome.
Johnson & Johnson decided to terminate a $1.6 billion partnership with Argenx to develop the anti-CD70 antibody cusatuzumab to treat amyotrophic lateral sclerosis (AML) and myelodysplastic syndromes (MDS).
Now, a few years down the road,
Shares of Aprea Therapeutics plunged after the Boston-based company announced a late-stage cancer combination treatment failed to meet the primary endpoint of complete remission rate.
The U.S. Food and Drug Administration and Health Canada approved Inqovi (decitabine and cedazuridine) tablets as the first orally administered hypomethylating agent for the treatment for adults with intermediate and high-risk myelodysplastic syndromes (MDS).
Helsinn Group, based in Lugano, Switzerland, and MEI Pharma, with headquarters in San Diego, announced they were discontinuing their Phase III trial of pracinostat with azacytidine in acute myeloid leukemia (AML).