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 lawsuit against Sandoz regarding Remodulin. The favorable ruling has removed … Continue reading Biotech Stock Update: Biotech Stocks Weekly Round Up

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 was awarded the voucher under an FDA program to encourage … Continue reading Biotech Stock News: BioMarin Updates 2014 Revenue View

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 gained 5.07% following the announcement. Juxtapid is approved as an … Continue reading Biotech Stock Update: Aegerion Resolves FDA’s Warning

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 ZA-305 study was the first of the two identical pivotal … Continue reading Biotech Stock News: Repros Stock Set For a Rise in Price

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 bring significant improvements in terms of safety or effectiveness in … Continue reading Biotech Stock News: Amgen Set for Big Things in the Near Future

United Therapeutics Corporation (UTHR) shares surged approximately 28.5% after the company announced that the U.S. District Court for the District of New Jersey has rendered a favorable decision in the Remodulin patent infringement lawsuit against Sandoz, the generic division of Novartis (NVS). As per the court’s ruling, Sandoz will not be able to launch its generic version of Remodulin until patent no. 6,765,117 protecting Remodulin … Continue reading Biotech News: United Therapeutics Remains Strong Due to a Patent Case Win