The treatment vs. maintenance conundrum raised by Clovis Oncology Inc.'s accelerated approval of Rubraca (rucaparib) therapy for advanced ovarian cancer is nothing new, Robert Coleman, one of the principal investigators in the ARIEL trial program, told BioWorld Today. Read More
Akcea Therapeutics Inc. reported that COMPASS, the first phase III study of volanesorsen, met its primary endpoint, with patients who received the drug (n=75) achieving a statistically significant (p<0.0001) mean reduction in triglycerides of 71.2 percent from baseline following 13 weeks of treatment compared with a mean reduction of 0.9 percent in placebo-treated patients (n=38). Read More
Just months after a phase III trial miss for TNX-102 SL in fibromyalgia elevated post-traumatic stress disorder (PTSD) to the lead indication for the Tonix Pharmaceuticals Holding Corp. drug, it has secured FDA breakthrough status in the condition, which is often tied to military combat trauma. Read More
The Yamanaka factors, which are used to create induced pluripotent stem cells (iPSCs) in test tubes, could slow down premature aging of mice with progeria, as well as certain aspects of regular aging, when they were transiently expressed in mice. By keeping expression times short and intermittent, the scientists prevented cells from becoming fully stem cell-like, thus avoiding the formation of tumors in the animals. Read More
HONG KONG – The CFDA approved the Roche Group's Actemra (tocilizumab), which targets systemic juvenile idiopathic arthritis (sJIA). The approval marks the entry of the first biologic in the Chinese market for the disease and could lower a long-standing reliance on corticosteroids to deal with the pain of joint inflammation among children. Read More
DUBLIN – Northern Biologics Inc. is merging with Spanish firm Mosaic Biomedicals SL and at the same time has lined up Celgene Corp. with an option to take forward Mosaic's key asset, MSC-1, a first-in-class antibody that targets leukemia inhibitory factor (LIF). Read More
Soligenix Inc., of Princeton, N.J., said it closed its underwritten public offering of 1.67 million shares of its common stock and warrants to purchase up to an aggregate of 2.08 million shares of its common stock at a combined offering price of $3.16. Read More
Threshold Pharmaceuticals Inc., of South San Francisco, plans to collaborate with the NIH's National Cancer Institute (NCI) to study TH-3424, the company's candidate to treat cancer. Read More
Contravir Pharmaceuticals Inc., of Edison, N.J., said tenofovir exalidex (TXL, formerly called CMX157), the company's prodrug analog of tenofovir, exhibited increased antiviral activity at the highest planned dose of 100 mg in the ongoing phase IIa multiple ascending-dose trial in patients with hepatitis B virus. Read More
