GSK’s (NYSE:GSK) Tykerb fails to hit its goal in a Phase III trial. The trial tested Tykerb use in women with early stage breast cancer. Tykerb, a rival to Roche’s (RHHBY.PK) Herceptin, is approved in 107 countries for treating metastatic breast cancer.
St. Jude Medical (NYSE:STJ) is down after an FDA panel vote. Recommendation was made to not use its CardioMEMS implantable heart device for treating heart failure. Potential risks could have outweighed the potential benefits said six of 10 members; uncertainty posed a negative recommendation. They could not determine whether the wireless pressure sensor and its supporting computer monitors’ benefits were overshadowed by the risks.
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Pharmacyclics (NASDAQ:PCYC) will collaborate with a JNJ (NYSE:JNJ) subsidiary to develop and commercialize an oral treatment of non-Hodgkins lymphoma, chronic lymphocytic leukemia and multiple myeloma. Thenear-term upside may be limited in 2012 given the vastly reduced probability that PCYC will be acquired therefore RBC Capital cuts its recommendation.
Spectrum Pharmaceuticals (NASDAQ:SPPI) shares fall after the FDA notes an unidentified company has applied to sell generic copies of Suilev. The firm’s CEO is taking on a onslaught of criticism over a lush stock award for 2011 of potentially as many as 2.87M shares.
Oncolytics Biotech (NASDAQ:ONCY) says most recent data from Phase 2 clinical trials using intravenous administration of Reolysin in combination with Gemzar in patients with advanced pancreatic cancer was successful in reaching its primary endpoint.