Alexion Pharmaceuticals’ (ALXN) sole marketed product is Soliris (eculizumab). Soliris is available for the treatment of two rare genetic disorders – paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. As the company is entirely dependent on Soliris for growth, it should look to avoid any setback related to the product. However, the FDA seems to…
Highlights in the biotech sector last week include a favorable court ruling for United Therapeutics’ (UTHR) in a patent infringement case, positive late-stage data on Repros Therapeutics’ (RPRX) testosterone replacement treatment and the filing of the first Biologics License Application (BLA) for a PCSK9 inhibitor. United Therapeutics scored a huge win in its patent infringement…
BioMarin Pharmaceutical (BMRN) lowered its guidance for 2014 revenues after a thorough evaluation of its transaction with Regeneron Ireland, an indirect, wholly owned subsidiary of Regeneron Pharmaceuticals. Along with its earnings release last month BioMarin had announced the sale of the rare pediatric disease priority review voucher for $67.5 million to Regeneron. The biopharmaceutical company…
Aegerion Pharmaceuticals, Inc (AEGR) announced that the Office of Prescription Drug Promotion (OPDP) of the FDA has issued a closeout letter with regard to its investigation of the company’s marketing and sales of Juxtapid in the U.S. The closeout letter signifies that the issues mentioned in the FDA’s warning letter have been resolved. Aegerion’s shares…
Repros Therapeutics Inc (RPRX) announced positive top-line data on its secondary hypogonadism candidate, Androxal, from a pivotal phase III study. Repros had initiated two identical, 17-week, double-blind ZA-304 and ZA-305 studies to compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) and placebo in restoring and maintaining testicular function. The…
Amgen Inc (AMGN) received encouraging news from the FDA as the regulatory body granted priority review status to the New Drug Application (NDA) for its pipeline candidate, ivabradine. Amgen is looking to get ivabradine approved for the treatment of chronic heart failure. Te FDA grants priority review status to candidates which have the potential to…
