GI Dynamics Inc.’s U.S. IDE trial of Endobarrier, which is designed for patients diagnosed with type 2 diabetes and obesity, is now underway with the first patient enrollment at Michigan Medicine in Ann Arbor, Mich. The FDA approved the pivotal STEP-1 clinical trial in August 2019 to evaluate the Endobarrier as a barrier between the small intestine and food to reduce calorie intake.
As Acceleron Pharma Inc.’s phase II trial of sotatercept hit its primary endpoint and some key secondary endpoints in significantly reducing pulmonary vascular resistance, the stock (NASDAQ:XLRN) reacted accordingly, gaining 50% on Jan. 28. The stock ended the day at $79.39, up $26.52.
BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections.
As attendees of last year’s American Society of Hematology (ASH) meeting heard, B-cell maturation antigen (BCMA)-targeting therapies are steadily gaining ground on various fronts, even as companies such as Springworks Therapeutics Inc. bring forward candidates that might boost activity of the class.
Expectations that a phase III trial of Ipsen SA's palovarotene will miss its primary endpoint of reducing abnormal bone growth among people with a rare bone disorder led the company to pause dosing in that study and another as it evaluates next steps.
Abbott Laboratories had a winning week, scoring U.S. FDA approval of its Infinity directional deep brain stimulation (DBS) system in treating symptoms of Parkinson’s disease not adequately managed by medication. The company also reported new data underscoring the benefits of its Proclaim XR neuromodulation system in people living with chronic pain.
The controversy over the use of paclitaxel-bearing devices in the femoropopliteal arteries is far from over. Now, a new medical journal article makes a similar claim about mortality in connection with the use of these devices in the infrapopliteal arteries, threatening once again to take a bite out of utilization.
Physician, scientist and investor Patrick Soon-Shiong might be considered a "square peg in a round hole," he admits. But the Abraxane inventor's work to enlist natural killer, dendritic and T cells in what he calls a "triangle offense" against cancer is finally coalescing, he recently told BioWorld.
BEIJING – With promising phase II data in hand – and newly designated FDA orphan drug status – Suzhou, China-based Tennor Therapeutics Suzhou Co. Ltd. is gearing up to move into pivotal testing with TNP-2092 to treat prosthetic joint infections. TNP-2092 is a multitargeting drug conjugate designed to exert antibacterial activity by inhibiting three essential targets in bacterial biofilms.
Nearly 70% of men with locally recurrent prostate cancer who received radiation therapy initially could delay androgen deprivation therapy (ADT) for at least five years following stereotactic body radiation therapy (SBRT) with Accuray Inc.’s Cyberknife system, according to a study published in the International Journal of Radiation Oncology • Biology • Physics.