Novartis is developing a companion diagnostic for Prexige and is evaluating its submission strategy for the painkiller with health regulators around the world. Can the Swiss drug giant use pharmacogenomics to resurrect a drug that already bears the stigma of being rejected by the FDA for liver safety concerns?
According to Whitehead, Alnylam and Max Planck's request to block the case represents an "eleventh hour … rush into court to seek emergency relief from a situation of their own making," and should therefore be denied.
CEO Jay Flatley attributed a "faster than expected slowdown" in the San Diego firm's array business to researchers delaying new rounds of genome-wide association studies. Customers are also waiting to see if their projects will receive stimulus funding, he said.
The San Francisco Bay Area and Boston/Cambridge, Mass., fared better in biotech activity than almost the entire next tier of large life-sci clusters, but worse than several up-and-coming regions, which saw either smaller year-to-year losses, or actual gains.
The suit is filed against the US Patent and Trademark Office's acting director and charges that the adjusted term of one of Alnylam's patents was inappropriately cut short by roughly a year and a half.
Second-quarter revenues declined 6 percent year-over-year while a loss in the year-ago period swung to a $7.3 million profit. The firm beat analysts' consensus estimates on both the top and bottom lines.
In order to make the labeling change, the agency reviewed retrospective data from seven clinical trials. But this is the exception, according to one official from a diagnostic company who believes FDA's lengthy deliberations have further nudged drug companies to advance diagnostics at the same time as therapeutics in prospective studies.
Asuragen is working with Biogen Idec to identify “a potential companion diagnostic test that may be used to select patients likely to respond to a Biogen Idec therapeutic candidate in clinical development.” However, Biogen Idec is keeping a tight lid on the project.
In doing so, the Whitehead Institute for Biomedical Research, the Massachusetts Institute of Technology, and the University of Massachusetts have all asked that the court reject Alnylam Pharmaceuticals and Max Planck's request for an order blocking any Tuschl-I patent issuance.
In the advance online version of Nucleic Acids Research, Santaris investigators reported data identifying miR-155, an miRNA involved in immune-system regulation, as a possible therapeutic target for chronic inflammatory diseases such as rheumatoid arthritis.