Two days ahead of Wednesday's PDUFA date for obesity drug lorcaserin, shares of Arena Pharmaceuticals Inc. continued to slide after a roller coaster of a ride last week. Read More
A month after efficacy findings from a pivotal Phase III study of VEN 307 (diltiazem hydrochloride cream) in anal fissures drove share prices higher, Ventrus Biosciences Inc. faced the market's wrath after its randomized, double-blind, placebo-controlled Phase III trial of VEN 309 (iferanserin ointment) failed in hemorrhoidal disease. Read More
With a district court judge ruling in favor of Teva Pharmaceutical Industries Ltd.'s patent infringement lawsuit, the Jerusalem-based big pharma should be able to prevent generic competition to its multiple sclerosis (MS) drug Copaxone (glatiramer acetate) from hitting the market until at least Sept. 1, 2015. Read More
Anticipation is making a lot of Supreme Court watchers wait a few more days to see if the court will release its opinion on the Affordable Care Act (ACA) this term. Read More
New data from an open-label Phase II extension study prompted Ablynx NV to claim Monday that its tumor necrosis factor alpha (TNF-alpha) inhibitor ozoralizumab (ATN-103) was back in the game. Read More
With a successful BIO 2012 behind us, thoughts turn to summer vacation and visions of sun, sand and afternoons lounging in a deck chair. What's on your reading list to fill some of that downtime? Read More
• MAP Pharmaceuticals Inc., of Mountain View, Calif., said it plans to resubmit its new drug application for Levadex (dihydroergotamine) inhalation aerosol for the acute treatment of migraine in adults in the late third quarter/early fourth quarter. Read More
• Generex Biotechnology Corp., of Worcester, Mass., said its Indian licensee, Shreya Life Sciences Pvt. Ltd., of Mumbai, plans to complete the Phase III study of Oral-lyn, Generex' proprietary buccal insulin spray product, in India by the end of July and begin statistical data analysis. To date, 125 patients at 14 sites have completed the Phase III study of Oral-lyn, branded in India as Recosulin. Read More
• Janssen-Cilag International NV, of Beerse, Belgium, said the Committee for Medical Products for Human Use of the European Medicines Agency (EMA) recommended approval of subcutaneous administration of Velcade (bortezomib), indicated for multiple myeloma. Read More
• Novo Nordisk A/S, of Bagsvaerd, Denmark, reported data from a subgroup analysis of the A1chieve study showing that intensifying treatment with NovoMix 30 (Biphasic insulin aspart) can significantly improve blood glucose control in people with Type II diabetes who have reduced incidences of hypoglycemia. Read More
