Newsmakers: Rockwell Medical, Questcor Pharmaceuticals, Nanosphere, Clovis Oncology, Clovis Oncology Print
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Monday, 23 June 2014 13:31
U.S. stocks were little changed on Monday following a six-day rally in the
benchmark S&P 500 and a mixed bag of global economic data. The Dow Jones industrial average was down 0.21 percent at 16,911.81, the S&P 500 was down 0.14 percent at 1,960.11 and the

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Nasdaq Composite was down 2.07 points, or 0.05 percent, to 4,365.96. A federal judge in Florida has overturned a jury verdict that had ordered Qualcomm to pay the
chipmaker $173 million for infringing patents for technology used in smartphones.

The FDA approves Rockwell Medical's ($RMTI) ANDA to manufacture Calcitrol, a low cost generic vitamin D drug. Calcitrol injection is indicated for the management of hypocalcemia in patients undergoing chronic renal dialysis.

Shares of Nanosphere ($NSPH) jump on heavy volume in response to its agreement with HealthTrust that offers access to its molecular diagnostic tests to 1,400 acute care facilities. No financial terms or sales projections are disclosed. The agreement became effective on June 1, 2014.

Questcor Pharmaceuticals ($QCOR) acquires the commercial rights to Novartis' (NVS -0.7%) Synachthen (tetracosactrin) and Synacthen Depot in all countries worldwide except 13 European countries where NVS previously granted the rights to a third party.

Citing strong underlying business performance and an expectation that the positive trends will continue, AbbVie ($ABBV) increases the midpoint of its full-year EPS guidance to $3.06 - 3.16 on an adjusted basis and $2.69 - 2.79 on a GAAP basis. The improved outlook excludes any potential revenues from its pending HCV therapy.

Clovis Oncology ($CLVS) initiates its TIGER2 registration study for CO-1686 with the dosing of the first patient. The EGFR inhibitor is being evaluated for the treatment of non-small cell lung cancer (NSCLC) in patients with the T790M mutation. In May, the FDA designated CO-1686 as a Breakthrough Therapy for the treatment of mutant EGFR NSCLC in patients with the T790M mutation after progression on EGFR-directed therapy.TIGER2 is one of three registration studies in the third-generation inhibitor of mutant EGFR in lung cancer program expected to start this year. 125 patients will participate in the trial. The primary endpoint is overall response rate. Secondary endpoints included duration of response, progression-free survival, overall survival and safety.

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