PHARMACY

FDA approves improved diagnostic test for viruses

BY Drew Buono

WASHINGTON The Food and Drug Administration has recently approved a new test for diagnosing respiratory viruses called the xTAG Respiratory Viral Panel, which was developed by McMaster University and Luminex Molecular Diagnostics, according to published reports.

This new test can detect the viruses in a few hours compared to old tests which would have required multiple individual diagnostic tests to be performed on a patient sample and could take several days to provide the same results as the xTAG test.

The FDA approval allows laboratories to use the test to simultaneously detect and identify 12 viruses and viral subtypes that together are responsible for more than 85 percent of respiratory viral infections, including influenza A, influenza A-H1, influenza A-H3, influenza B, Adenovirus, respiratory syncytial virus A and B, metapneumovirus, parainfluenza 1, 2, and 3, and rhinovirus.

“Respiratory viruses affect millions of people each year and can lead to serious complications such as bacterial super infections and pneumonia. The RVP test allows healthcare providers to more rapidly and accurately detect infected patients and take appropriate measures to treat and reduce the spread of the disease,” said James Mahony, director of the McMaster University Regional Virology and Chlamydiology Laboratory at St. Joseph’s Healthcare Hamilton and professor in the Department of Pathology and Molecular Medicine.

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Lilly and PsychoGenics partner on neuropsychiatric disorder treatments

BY Drew Buono

TARRYTOWN, N.Y. PsychoGenics and Eli Lilly have entered into a drug discovery agreement aimed at identifying drug candidates suitable for clinical developments.

Per the agreement, Lilly will supply precandidate compounds that PsychoGenics will evaluate using its proprietary drug discovery technologies for the treatment of neuropsychiatric disorders. Upon Lilly’s further development of clinical candidates, PsychoGenics would receive research and milestone payments, as well as royalties.

Emer Leahy, president and chief executive officer of PsychoGenics, said, “We are delighted to once again work with Lilly and play an integral and expanding role in a successful drug discovery collaboration. We are confident that by combining the complementary strengths and expertise of PsychoGenics and Lilly, we may identify a new generation of treatments for neuropsychiatric disorders.”

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Roche asks for clearance to bring Mircera to market

BY Drew Buono

BASEL, Switzerland Roche is asking a U.S. judge for clearance to sell an anti-anemia drug by offering a royalty to Amgen and offering the drug at a price that is lower than what Amgen charges for its top anemia drug, according to published reports.

Roche won regulatory approval for Mircera as a treatment for anemia associated with kidney disease in November. But it hasn’t brought the drug to market because it lost a civil trial in October in which a federal jury found Mircera violated patents held by Amgen. Amgen sells drugs Aranesp and Epogen to treat anemia associated with kidney disease and cancer chemotherapy.

Although Roche lost the patent trial to Amgen, it is now seeking permission from Judge William Young to bring Mircera to the market by arguing that it would serve the public interest. Roche also has proposed selling Mircera at an initial “wholesale acquisition cost” that is about 5 percent less than the current “average selling price” of Amgen’s Aranesp. Also, it would pay Amgen a royalty 20 percent of net sales of Mircera while Amgen’s patents are still enforced, assuming the original ruling of infringement stands.

Roche said it would begin taking steps to market Mircera if the judge doesn’t rule on Amgen’s injunction request on Feb. 28, when oral arguments are scheduled in the case. Roche would be doing this even though they would be at risk to pay Amgen penalties if the infringement case isn’t overturned.

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