Astellas Pharma Inc. is buying Belgium's Ogeda SA for €500 million (US$532.7 million) up front and up to €300 million in milestone payments tied to the clinical and regulatory advancement of fezolinetant, a midstage nonhormonal treatment for menopause-related vasomotor symptoms (MR-VMS). If successful, it could potentially broaden the options for women seeking an alternative to estrogens and progestogens, which though commonly used to treat MR-VMS, have been associated with heightened risks of breast cancer, stroke and thromboembolism. Read More
Caladrius Biosciences Inc., of Basking Ridge, N.J., said it added four sites to its phase II trial of CLBS03 in type 1 diabetes, the Sanford Project: T-Rex Study, helping to meet the enrollment goal of 111 patients. Read More
Veloxis Pharmaceuticals A/S, of Copenhagen, said its U.S. subsidiary inked an exclusive license, supply and distribution agreement with Taiba Healthcare, of Muscat, Oman, to register, commercialize and distribute Envarsus XR (tacrolimus) in certain countries throughout the Middle East and North Africa, or MENA, region. Read More
Last year wasn't the best for venture capital investments in U.S. private companies, with the total for the year headed in the wrong direction, failing to match 2015 levels. (See BioWorld Today, Jan. 4, 2017.) Read More
Bristol-Myers Squibb Co. (BMS) fell back in the immuno-oncology (I-O) pack last year after reporting that its blockbuster, Opdivo (nivolumab), failed to achieve statistically significant progression-free survival (PFS) in the phase III CHECKMATE-026 trial testing the PD-1 immune checkpoint inhibitor as a monotherapy vs. platinum-based chemo in patients with first-line non-small-cell lung cancer (NSCLC) whose tumors express PD-L1 at greater than 5 percent. Read More
WASHINGTON – Data from the Heracles and SUMMIT trials presented at the 2017 annual meeting of the American Association for Cancer Research confirmed that HER2-targeting drugs, which were originally developed for breast cancer, can be useful both for treating other tumor types and for patients whose HER2 gene is mutated but who do not overexpress HER2 protein. Read More
WASHINGTON – As scientists gathered at the 2017 meeting of the American Association for Cancer Research (AACR) to learn about the latest advances in cancer research, one of the questions was how much of that research would hold up to attempts to reproduce it. Read More
Diagnostics player Cancer Genetics Inc. (CGI) has paired up with artificial intelligence (AI) company Mendel Health to incorporate deep learning into clinical trial matching. Read More
The U.S. SEC released a final rule making technical amendments to the Jumpstart Our Business Startups (JOBS) Act and adjusting caps on crowdfunding and emerging growth companies (EGC) to reflect inflation. Read More
Tocagen Inc., of San Diego, has filed to offer 7.25 million shares priced at $10 to $12 per share in its IPO. The company plans to list on Nasdaq under the ticker symbol TOCA. Read More
Essa Pharma Inc., of Vancouver, British Columbia, said EPI-506 remained well-tolerated through six cohorts of patients with metastatic castration-resistant prostate cancer at escalating doses in its ongoing phase I trial. Read More
