Phase III
Shares of Akebia Therapeutics are up more than 10 percent in premarket trading after the company announced it struck a merger agreement with Keryx Biopharmaceuticals, Inc. to create a company expected to be a leader in the development of renal disease therapies.
Global Blood Therapeutics (GBT) reported the results of a review of Part A of its Phase III HOPE (Hemoglobin Oxygen Affinity Modulation to Inhibit HbS PolymErization) Study of voxelotor for sickle cell disease.
AstraZeneca and Merck announced positive results from their Phase III SOLO-1 clinical trial of Lynparza (olaparib) in BRCA-mutated (BRCAm) advanced ovarian cancer.
Less than a week after floating the idea of offering its experimental ALS therapy NurOwn to patients under the recently-passed Right-to-Try legislation, Israel-based BrainStorm Cell Therapeutics has reversed course.
The FDA accepted Genentech’s New Drug Application (NDA) for baloxavir marboxil, a single-dose, oral flu treatment for people 12 years and older. It also granted it Priority Review.
An experimental triple combination treatment for cystic fibrosis has landed Vertex Pharmaceuticals at the top of EvaluatePharma’s “World Preview 2018” list.
Although it’s great to report on successful clinical trial results, the reality is that only about one in 10 drugs make it to approval. With that number in mind, here are a couple companies reporting problematic clinical trials today.
Roche announced that its Phase III IMpower 133 clinical trial of Tecentriq (atezolizumab) plus carboplatin and etoposide chemotherapy met its co-primary endpoints.
Nanobiotix announced positive topline data from its Phase II/III clinical trial of NBTXR3 in soft tissue sarcoma (STS). Shares climbed by more than 50 percent at the news.
For type 1 narcolepsy, this sleep-wake instability is linked to low levels of hypocretin, also called orexin. Hypocretin is a neurotransmitter produced in the hypothalamus and has a significant role in wakefulness and regulating rapid eye movement (REM) sleep. But Harmony Biosciences has found another link, this one to histamine.
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