Amgen Inc (AMGN) has filed a lawsuit against Sanofi (SNY ) and Regeneron Pharmaceuticals, Inc. (REGN) in the U.S. District Court of Delaware. The lawsuit is related to the infringement of certain patents (patent numbers 8,563,698, 8,829,165, and 8,859,741) owned by Amgen which describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9). Sanofi and Regeneron are jointly developing alirocumab (proposed trade name: … Continue reading Biotech Stock News: Amgen Sues Sanofi and Regeneron

AbbVie Inc (ABBV) has announced that it jointly agreed with Shire plc (SHPG) to terminate the planned acquisition of the latter, which was due to be completed by year end. We remind investors that in Jul 2014, AbbVie had agreed to acquire Shire for approximately £53.19 per Shire share (£24.44 in cash and 0.8960 ordinary shares of the merged company for each Shire share). The … Continue reading Major Biotech Stock News: AbbVie Drops Shire Deal

Prosensa Holding N.V. (RNA) announced that it has initiated the process of rolling submission of a new drug application (NDA) to the FDA for its lead candidate, drisapersen, for the treatment of Duchenne muscular dystrophy (DMD). Drisapersen has Breakthrough Therapy Designation in the U.S. Moreover, the fast track status for drisapersen has made Prosensa eligible for making a rolling NDA submission for the candidate. According … Continue reading Biotech Stock News: Prosensa Starts Rolling NDA Submission, Stock Reacts

Alnylam Pharmaceuticals, Inc (ALNY) revealed encouraging initial results from an ongoing phase II open-label extension study (n=27) on one of its most important pipeline candidates, patisiran (ALN-TTR02). The stock soared almost 19% following the announcement. Patisiran, one of the most advanced candidates at Alnylam, is a subcutaneously administrated ribo nucleic acid interference (RNAi) therapeutic being developed for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR) in … Continue reading Biotech Stock News: Alnylam Jumps on Positive Patisiran Data

Investors in the pharma/biotech sector eagerly wait for pipeline updates as they play an important role in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized. Late last week, Amgen (AMGN) provided an update on its cancer … Continue reading Biotech Stock News: Amgen’s Blinatumomab Gets Priority Review

Amgen Inc (AMGN) was up almost 3% on encouraging top-line data from a phase III study on its biosimilar candidate, ABP 501. The randomized, double-blind, active-controlled study compared the safety and efficacy of ABP 501 to AbbVie Inc’s (ABBV) Humira in adults suffering from moderate-to-severe plaque psoriasis. The study met its primary endpoint of Psoriasis Area and Severity Index (PASI) percent improvement from baseline at … Continue reading Biotech Stocks: Amgen Up Due To Positive Phase III Data