Extending the FDA's priority review voucher (PRV) program to include the Ebola virus would not need an act of Congress, but one of its inventors – David Ridley at Duke University – is doing what he can to make the moves happen there. Read More
Though it still has aims of securing a partner for phase III-ready diabetes drug sotagliflozin, Lexicon Pharmaceuticals Inc. is bolstering its balance sheet with a $50 million public offering and a concurrent $80 million convertible note offering ahead of a planned pivotal program set to start next year. Read More
BETHESDA, Md. – Sponsors know they have a difficult path to traverse to persuade payers that their molecular diagnostics have the effect sought by those payers, but the problems are more numerous than just the questions surrounding the evaluation methodology. Read More
HONG KONG – The anti-diabetic drug, metformin, is a promising candidate for an effective adjunctive host therapy for boosting the efficacy of current tuberculosis (TB) treatments, Singapore Immunology Network (SIgN) researchers with the Agency for Science, Technology and Research (A*STAR) reported in the Nov. 19, 2014, edition of Science Translational Medicine. Read More
Just six months after revealing a $10.3 million private placement to back development of a once-shelved therapy, Corbus Pharmaceuticals Holdings Inc. is preparing to submit an investigational new drug application to jump straight into a phase IIa trial of its sole program, an anti-inflammatory therapy it calls Resunab. Read More
Checkpoint inhibitors (CIs) are among the hottest tickets in biopharma, with a handful of deals this year showing that no respectable oncology pipeline can be without one. Combined with traditional chemotherapy and radiation treatment, CIs made a big first impression in metastatic melanoma, thanks to the early success of Yervoy (ipilimumab, Bristol-Myers Squibb Co.). Read More
Swedish Orphan Biovitrum AB (Sobi), of Stockholm, exercised its opt-in right to control final development and commercialization of Elocta (rFVIIIFc) for the territory that includes Europe, North Africa, Russia and most of the Middle East. Read More
Galena Biopharma Inc., of Portland, Ore., said it had executed a purchase agreement for up to $55 million with Lincoln Park Capital Fund LLC. The fund initially purchased $5 million of the company's common stock at $2 per share, a premium of 9 percent on market close stock price as of Nov. 18. Read More
Intra-Cellular Therapies Inc., of New York, said it presented at the Clinical Trials on Alzheimer's Disease conference additional results from ITI-007-200, a phase I/II trial designed to evaluate the safety, tolerability and pharmacokinetics of low doses of its lead drug candidate, ITI-007, in healthy geriatric subjects (part 1) and in patients with dementia, including Alzheimer's disease (part 2). Read More
Basilea Pharmaceutica Ltd., of Basel, Switzerland, said the FDA disclosed a public meeting of the Anti-Infective Drugs Advisory Committee to discuss the new drug application for the antifungal isavuconazole, which was submitted by a subsidiary of Basilea's licensing partner Astellas Pharma Inc., of Tokyo. Read More
A team from the Beth Israel Deaconess Medical Center has developed a new way to deliver anti-microRNA drugs into the tumor microenvironment. Several microRNAs, and miR-155 in particular, have been implicated in the progression of cancer, and blocking their effects via the antisense miRs (antimiRs) could be a useful therapeutic strategy. Read More
