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…
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…
The biotech sector had a strong run last week thanks mostly to Roche’s agreement to acquire InterMune (ITMN) for a hefty $8.3 billion. The announcement of this deal resulted in a spike in the share price of quite a few mid-cap biotech companies that are considered to be lucrative acquisition targets. The week’s most important…
Biotech is back. This spring, biotech stocks collapsed. The Nasdaq Biotechnology Index tumbled 22% in about six weeks, inflicting huge losses on hedge funds and other investors, including holders of a popular exchange-traded fund known for its ticker “IBB,” the iShares Nasdaq Biotechnology ETF , which has about $5.5 billion in assets. So far in…
