Today, Roche put out the word that their PD-L1 drug MPDL3280A won the FDA's coveted breakthrough therapy designation, potentially putting it on an inside track at the agency, which has been hurrying along new medicines in the pipeline.
Over the long holiday weekend, Dainippon Sumitomo's shares took a beating--dropping 21% at one point, according to Bloomberg--as investors reacted to the news that BBI608 proved to be a dud in its most advanced trial for colorectal cancer.
Shares of Isis Pharmaceuticals surged 9% this morning as the Carlsbad, CA-based antisense drug developer posted positive outcomes for a head-to-head Phase II study comparing ISIS-FXIRx with Lovenox on thrombosis. The biotech says the top 300 mg dose of its therapy beat out the widely used anticoagulant, lowering the number of blood clots while reducing the number of bleeding incidents.
Rivals Novartis and Boehringer Ingelheim are touting positive results for their combination COPD treatments, duking it out with GlaxoSmithKline for dominance of a market that could reach $14 billion by 2018.
Now that the ovarian cancer drug vintafolide has crumbled in Phase III, Merck and its partner Endocyte have pulled their conditional marketing application in Europe and are moving to close down the study.
The latest download of data on a pair of rival therapies for lethal cases of idiopathic pulmonary fibrosis wowed researchers in the field, producing clear evidence of their ability to slow down the lung disease and offering patients a possible set of game-changing treatments.
Shares of Cambridge, MA-based bluebird bio shot up after CEO Nick Leschly noted the looming arrival of early-stage data for its drug LentiGlobin, designed to treat the rare blood disorder beta thalassemia.
Myriad Genetics paid $270 million for Crescendo Bioscience in February, and now a new study affirms the clinical viability of Crescendo's Vectra DA, a protein-based test designed to assess a patient's rheumatoid arthritis disease progression and activity.
At first glance, you might suspect that Gene Signal's Phase III study of its lead drug for a rare eye disease was a roaring success. But if you dig down into its release today, you'll find that the drug flunked its primary endpoint--an inconvenient truth that is dismissed as a mere triviality.
Isis says its lead diabetes drug scored a success in a Phase II study, with both doses of ISIS-GCGR spurring a significant drop in blood glucose levels after 13 weeks of therapy in a group of treatment-resistant patients. And the antisense therapy hit its marks on HbA1c without spurring some of the troubling side effects that may hinder rival therapies in the pipeline.