PDUFA: Oct 16 — Santarus, Inc **Extended to January 16, 2013**
Santarus, Inc. expects an FDA decision under the Prescription Drug User Fee Act (PDUFA) on the approval status of UCERIS, being developed for the treatment […]
Santarus, Inc. expects an FDA decision under the Prescription Drug User Fee Act (PDUFA) on the approval status of UCERIS, being developed for the treatment […]
Supernus Pharmaceuticals [Nasdaq: SUPN] expects an FDA decision under the Prescription Drug User Fee Act (PDUFA) on the approval status of SPN-804, being developed for […]
The San Diego-based pharmaceutical company has five approved products internationally, covering erectile dysfunction (Vitaros), side effects of cancer therapy (Totect and Granisol), coronary artery disease (Nitromist) and dry mouth (Aquoral). After a series of successes in strategic partnerships, acquisitions, peer review and clinical data in Q3, the company is garnering some serious attention.
To the scientific community, the Ebola virus is one of the most noxious pathogens identified to date. To the general population, the virus is dreadful, made especially frightening in pop culture.
September is Sickle Cell Awareness Month, a time when the medical community will gather with the patient population in the hopes of advancing research in this significant unmet medical need. One company, ADVENTRX Pharmaceuticals [NYSE: ANX], is attempting to engage the investor community and the sector’s most promising drug developers through the First Annual Sickle Cell Disease Therapeutics Conference, taking place September 19th, 2012 in New York City.
Pluristem Therapeutics Inc. announced that it has priced a firm commitment underwritten public offering of 8,000,000 units, with each unit consisting of one share of the company’s common stock and one warrant to purchase 0.35 of a share of the company’s common stock, at a purchase price of $4.00 per unit for an aggregate gross offering amount of $32 million. The offering is expected to close on or about September 19, 2012, subject to customary closing conditions.
With the end of summer, conference season is upon us! Not OneMedForum, of course, which doesn’t kick off until “Biotech Week” in mid-January. But in […]
Arena and Vivus’ approval of their obesity drugs — the first such approved in 13 years — have sent shockwaves throughout the industry. With Orexigen’s drug on the way, these have the potential to dramatically alter an entire sub-sector once left for dead. Still, despite positive data and FDA support, these drugs did not reach approval phase without several speed bumps along the way. And more questions are yet to come.
Opexa Therapeutics, Inc. today announced the initiation of a Phase IIb clinical trial of Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), in patients with Secondary Progressive Multiple Sclerosis (SPMS). The therapy is specifically tailored to each patient’s individual disease profile and has demonstrated superior safety and encouraging indications of efficacy in previous clinical studies in MS that included the treatment of SPMS patients.
With the 2012 Presidential election upon us, healthcare – both as a social service and essential sector of our economy – is once again a main pillar in the heated political debate. Ann Romney and Michelle Obama, both with a direct connection to Multiple Sclerosis, have opened up to campaign supporters in recent months about the effects of this debilitating disease.
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