The seventh biopharma to price its initial public offering (IPO) last week, Argos Therapeutics Inc. cut its share price but upped the number of shares to raise $45 million, bringing biopharma’s total IPO haul to nearly half a billion – $483.4 million – for the first week of February. Read More
The “not-testosterone” mantra long chanted by Repros Therapeutics Inc. with regard to its Androxal (enclomiphene), for secondary hypogonadism finally took hold, and the FDA agreed that the company will not need new safety tests before submitting the new drug application (NDA) before the end of this year. Read More
Orphan-drug specialist, Sigma-Tau Pharmaceuticals Inc. is developing a new class of drugs: live biotherapeutics. As the name implies, Sigma-Tau’s drug candidate, STP206, is a live organism used to repopulate patients’ gastrointestinal tracks. Read More
Recently, reports that levels of vitamin E that are typical for nutritional supplements could hasten the progression of existing tumors provided an unexpected cautionary tale about the health benefits of antioxidants. Read More
For nearly two decades, scientists have appreciated the healing power of nitric oxide (NO), a free radical that garnered researchers at three U.S. institutions the 1998 Nobel Prize in Physiology or Medicine for their discoveries involving NO as a signaling molecule in the cardiovascular system. Despite its promise, NO’s potential has been limited by the fact that the substance is gaseous and highly reactive, confounding the ability of drug developers to store and deliver it safely in the right amount, to the right location and at the right time. Read More
Covis Pharmaceuticals Inc., of Cary, N.C., said Lanoxin is now offered in four dosage strengths, including 0.0625 mg and 0.1875 mg, for the treatment of mild-to-moderate heart failure in adults, and for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Read More
Addex Therapeutics SA, of Geneva, disclosed top-line data from a phase IIa study of ADX71149 in anxious depression, conducted by Janssen Research & Development LLC, of Raritan, N.J., part of Johnson & Johnson. Overall, ADX71149 was well tolerated and treatment emergent adverse events reported were similar to those seen in previous clinical studies. Read More
Shire plc, of Dublin, disclosed top-line phase III data with Vyvanse (lisdexamfetamine dimesylate) capsules as an adjunctive treatment for major depressive disorder in adults who inadequately responded to antidepressant monotherapy with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor. Read More
Novelos Therapeutics Inc., of Madison, Wisc., closed a non-brokered private placement of two-year, 8 percent convertible debentures and warrants, raising gross proceeds of $4 million. Read More
A team from the National Institutes of Neurological Disorders and Stroke and the University of Cincinnati has shown that platelets may be a good cell type for gene therapy to treat certain lysosomal storage disorders. Read More