Biotech and pharmaceutical companies put the brakes on a few clinical trials but also announced positive recommendations for European regulatory approvals Friday.
First, biotechnology company
put on hold clinical development of MAXY-alpha, a treatment for hepatitis C and hepatitis B virus infections.
Maxygen, which licenses the drug to Roche, said that in the phase I trial, it
observed a reduction of efficacy in the majority of patients who received two doses of MAXY-alpha.
Shares gave up 89 cents, or 10.8%, to $7.36 but did little to detract from the Nasdaq biotechnology index, which was up 6.06, or 0.8%, to 849.24.
said it halted its own phase II STEP study, a proof-of-concept trial for an investigational HIV vaccine (V520), because the vaccine wasn't effective. The trial was co-sponsored by Merck and the HIV Vaccine Trials Network. Merck's shares were still up 52 cents, or 1%, at $51.90.
said Friday that the European Committee for Medicinal Products gave a positive opinion on Nexavar for liver cancer, recommending that European regulators give the drug marketing authorization. Onyx rose 82 cents, or 2%, to $41.70, and Bayer was trading down $2.01, or 2.5%, at $79.14.
The CHMP also gave a positive opinion recommending a conditional marketing authorization for
Vectibix in the EU for patients with refractory metastatic colorectal cancer with nonmutated (wild-type) KRAS genes. Amgen was up 35 cents, or 0.6%, at $55.66.
submitted a new-drug application to the Food and Drug Administration for approval of Treanda for patients with chronic lymohcytic leukemia, or CLL, a blood and bone marrow disease.
The company has orphan drug designation for Treanda, which would be the first new therapy to market for CLL since 2001 if its approved by the FDA. Cephalon rose 74 cents, or 1%, to $73.35.
And last, eye health company
Bausch & Lomb
said Friday that a majority of its shareholders officially approved the takeover deal with private equity firm Warburg Pincus. Shares of Bausch & Lomb were trading up 18 cents, or 0.3%, to $63.81.