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…
Regado Biosciences, Inc (RGDO) announced that it is permanently terminating the enrollment process for its phase III REGULATE-PCI study on Revolixys Kit. Regado’s shares tumbled over 60% on the news. Regado was dealt a severe blow with the Data and Safety Monitoring Board for a late-stage study recommending the permanent termination of patient enrolment. The…
In a move which can have a lasting impact in the biotech segment of the stocks market, Bristol-Myers Squibb Company (BMY) entered into a collaboration with Celgene Corporation (CELG) to asses the safety, tolerability and preliminary efficacy of a cocktail therapy including its high potential immuno-oncology drug Opdivo (nivolumab, a PD-1 immune checkpoint inhibitor) and…
