Pushing back against pressure to shorten the path to the U.S. market for new drugs and medical devices, the FDA has released an analysis of nearly two dozen case studies in which phase III trials didn't bear out the promises of phase II testing. Read More
Boston Biomedical Inc., of Cambridge, Mass., presented data from two studies for its lead investigational compound, napabucasin, at the 2017 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco. Read More
TOKYO – The stocks of Japan's biopharmaceutical companies have taken a hit since U.S. President Donald Trump said, almost two weeks ago, that pharma companies have been "getting away with murder." Unlike their U.S. counterparts, Japanese stocks have not recovered from that significant broadside. Read More
Jaakko Lappalainen, vice president of clinical development for Marinus Pharmaceuticals Inc., told BioWorld Today that early phase II success with ganaxolone against cyclin-dependent kinase-like 5 (CDKL5) seizure disorder should not necessarily have taken anyone by surprise, despite a phase III setback last June with the same treatment in drug-resistant focal onset seizures. Read More
Though still considered "correctable" by company execs, the manufacturing troubles that have beset lead acute myeloid leukemia (AML) candidate APTO-253 since late 2015 prompted Aptose Biosciences Inc. to make the tough decision to shift its resources to a preclinical-stage AML asset in-licensed last year. Read More
DUBLIN – Domain Therapeutics SA could receive up to €240 million (US$257 million) in an up-front payment, potential milestones and eventual sales royalties from a licensing deal with Merck KgaA on its preclinical program of adenosine receptor modulators in development for immuno-oncology applications. Read More
Rondinx, of Tel Aviv, said it completed the first phase of its benchmarking project to establish a database of microbiome growth dynamic ranges from healthy individuals. Read More
