Forest Laboratories Inc. joined the litany of big pharma companies announcing restructuring programs last week. But the major restructuring, dubbed Project Rejuvenate, appears to be more about streamlining operations than downsizing.
A recent report on the cost of bringing an asset from discovery to the market place has increased significantly for pharmaceutical companies over the last four years but returns on their investments have not kept pace. This state-of-affairs has caused these firms to adjust their business plans accordingly.
There is no doubt that ongoing research in nanotechnology is finally opening the door to potential new therapeutic applications. Though the next phase in its evolution will see the translation of promising lab discoveries into the clinic, it’s all still in formative stages. But confidence is building that innovative medicines and companion diagnostics based on nanotech will soon expand treatment options for major diseases such as cancer and central nervous system (CNS) disorders.
Positive results in a Phase II trial of its breast cancer drug neratinib sent stock in Puma Biotechnology Inc. skyrocketing 68 percent Thursday. In the trial, a combination of neratinib and Taxol unexpectedly outperformed a Herceptin/Taxol combination by 18 percent to 19 percent, according to analyst estimates.
Auxilium Pharmaceuticals Inc., of Chesterbrook, Pa., said the U.S. District Court for the District of Delaware granted a motion from Upsher-Smith Laboratories Inc., of Maple Grove, Minn., for a summary judgment with respect to its attempts to bring a testosterone gel product to market via the 505(b)(2) pathway using Auxilium’s Testim product as its reference drug.
Biogen Idec Inc., of Weston, Mass., and Swedish Orphan Biovitrum AB, of Stockholm, Sweden, disclosed positive results from A-LONG, a Phase III trial that evaluated a long-lasting clotting factor candidate in people with hemophilia A.