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SPOTLIGHT: Silver lining to Big Pharma's cloud?
Some people see the Big Pharma glass as half-full instead of the alternative. In an investor's-eye look at the industry, Kiplinger ticks off the usual criticisms: patent expirations, tough generics Read more...
Eisai wins expert panel's approval for new sedative
Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures, Read more...
Astellas faces new delay for Advagraf approval
Japan's Astellas Pharma has run into a new roadblock in its pursuit of regulatory approval of Advagraf, its second generation version of the blockbuster transplant drug Prograf. The FDA has raised Read more...
FDA staffers say that Eisai sedative appears safe
FDA staffers say that an experimental sedative developed by Eisai appears to be safe, but wants outside experts to consider whether it's safe enough to be administered by workers untrained in Read more...
Purdue jumps ahead in pain drug race
With three significant development programs at work on a tamper-free alternative to the blockbuster OxyContin franchise, Purdue Pharma is bracing for an upcoming FDA panel review of its new pain Read more...
FDA approves Wyeth, Progenics drug
There's a big sigh of relief coming from Wyeth and Progenics today as the FDA approved Relistor, a subcutaneous injection for opioid-induced constipation in patients with advanced illness who are Read more...
Genzyme gets biosimilar rejection, builds R&D plant
The FDA have given a thumbs down to Genzyme's request for permission to sell its Pompe disease drug Read more...
CV scores $185M royalty deal on Lexiscan
Just a week after gaining regulatory approval for Lexiscan (regadenoson), an injection that increases Read more...
Canada's streamlined approval process raises protests
Canadian officials are batting down critics who say that the country's new, streamlined drug approval process will let unsafe therapies onto the market. The dispute centers on Canada's new standard Read more...
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