It looks as if user fees really are in the offing for generic drugs. After generics makers said last week that they’re supporting the idea as a way to speed approvals of their products, FDA Commissioner Margaret Hamburg backed it, too. Revamping the current approvals process is “critical,” she said, because agency funding won’t provide [...]
Medco Health Solutions Inc’s (MHS.N) quarterly profit rose 11 percent on increased mail deliveries of generic drugs, but its shares fell as the report failed to excite investors. The U.S. pharmacy benefit manager reported a fourth-quarter profit, excluding special items, that matched Wall Street’s target and it backed its 2011 forecast. Its shares fell 4.5 [...]
India’s No.2 drugmaker Dr Reddy’s Laboratories Ltd said a U.S. district court has cleared the sale of its generic version of Sanofi-Aventis’ allergy medicine Allegra D24, sending its shares up nearly 4 percent. The U.S. District Court of New Jersey lifted an injunction passed last June against the Indian drugmaker from selling a copycat version [...]
More drugmakers are seeing potential in the business of producing copycat versions of expensive biotechnology drugs as U.S. guidelines take shape. The topic was at the forefront of plans discussed by several executives at this week’s JP Morgan healthcare conference in San Francisco. Kevin Sharer, chief executive officer at Amgen Inc, said the world’s largest [...]
Coupons work. That’s what drugmakers have discovered from the co-pay assistance they’ve been offering to shore up demand for aging branded drugs (Pfizer’s statin Lipitor), create demand for new ones (such as Amgen’s bone drug Xgeva and Novartis’ multiple sclerosis pill Gilenya), and insulate patients from big price increases (Jazz Pharmaceuticals’ narcolepsy treatment Xyrem). As [...]
According to recent research the color, shape, taste and even name of a tablet or pill can have an effect on how patients feel about their medication. Choose an appropriate combination and the placebo effect gives the pill a boost, improves outcomes and might even reduce side effects. Now, researchers at the University of Bombay, [...]
The FDA’s marathon run toward a new set of regulations to govern the development of biosimilars is official. Regulators will host their first public meeting on follow-on drug regs, and you can expect to hear plenty from big companies like Amgen on the need for lengthy and expensive clinical trials.
The Big 3 drug wholesalers in the U.S.–AmerisourceBergen, McKesson and Cardinal Health–are enjoying a financial boost this year thanks to the growing use of generic drugs. That’s a bus they hope to ride into 2011 and beyond, when they can expect drug distribution’s next big business-shaker: healthcare reform.
A group of European experts are pondering a new set of rules to govern the development of biosimilar monoclonal antibodies, paving the way for a lower-cost version of some of the world’s priciest therapeutics. But despite the big market that waits for these biosimilars, regulators say this field will be so tough to crack that [...]
GlaxoSmithKline and partner Theravance (THRX) say that their planned successor for the blockbuster Advair turned in a positive performance in a mid-stage study involving 60 people with COPD. Significantly, the new drug–dubbed Relovair–outperformed Advair on a key measure that gauges lung function. And that bodes well for the therapy, which is now in late-stage trials [...]
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