Thrombolytic Sciences announced completion of Phase I TS01 trial

A clinical stage vascular health and biotech company, Thrombolytic Science, LLC (TSI), announced the completion of its Phase I trial investigating TS01, which is a new-generation clot-dissolving therapy for the treatment of clot-induced diseases like ischemic stroke and acute myocardial infarction or heart attack. The clinical trial was the first-in-man placebo-controlled study that aimed to demonstrate safety and tolerability of the interventional drug in healthy adults.

Brainstorm starts the Phase III trial investigating NurOwn for ALS in the US

BrainStorm Cell Therapeutics have announced the initiation of Phase III trial of NurOwn, which will be managed by Wordwide Clinical Trial (CRO) for the treatment of amyotrophic lateral sclerosis (ALS) as an investigative stem cell therapy. The strategy of treatment arose from the use of Mesenchymal Stem Cells to differentiate into any type of adult stem cells, and thus the patients with ALS will be harvested of their MSCs, which would be then enginnered to produce additional growth factors to support the survival of motor neurons. The therapy has already been tested before in Phase I and II trials, paving way for a Phase III trial by the FDA.

Anti-cancer biosimilar of Amgen and Allergan, Mvasi, receives FDA approval

The US Food and Drug Administration, on September 18 2017, approved Myasi for cancer indications including non-squamous non-small-cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa, and for persistent, recurrent, or metastatic carcinoma of the cervix. The drug is a biosimilar of bevacizumab (Avastin), and has been co-developed by Amgen and Allergan. The FDA approved the biosimilar based on the bioequivalence studies with Avastin, which showed no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products.

Positive CHMP opinion awarded to GSK and Innoviva’s Trelegy Ellipta for the treatment of COPD

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for marketing authorisation of Trelegy Ellipta as a maintenance treatment in adult patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). This name has been proposed to be the brand name of fluticasone furoate / umeclidinium / vilanterol (FF / UMEC / VI), and has been jointly developed by GlaxoSmithKline (GSK) and Innoviva. This treatment is being developed for patients that have not been treated or have not responded to a combination of an inhaled corticosteroid and a long-acting beta2-agonist.