Bristol-Myers Squibb agreed to license its HIV fighter Reyataz (atazanavir) to the Medicines Patent Pool, which will allow generics makers to turn out cheaper copies for sale in poor countries.
Cymbalta is going down. The question for Eli Lilly is how fast and how far. Last evening, the FDA approved more than a half-dozen generic versions of Cymbalta, the antidepressant that's now Lilly's top-selling drug.
The global drug wholesaling industry is in the midst of a wheeling-and-dealing binge as wholesalers and pharmacy chains look to secure supplies at the best prices.
Robert Wessman, the Icelandic entrepreneur who built Actavis into a generics powerhouse and then sold out, has decided get into the biosimilars business. He has talked his home country into helping finance his plans.
Pfizer has always been proud of its design of Viagra, which has become known worldwide for its blue color and diamond shape. It thinks enough of it that it is fighting a pitched legal battle in Korea with drugmaker Hanmi Pharmaceutical over the shape of Hanmi's generic, which has grabbed nearly half the market there.
Mylan said today that it and Indian biologics partner Biocon have nabbed the first approval in India and will have a biosimilar of Herceptin (trastuzumab) ready to roll out early next year.
New pay-for-delay lawsuits are popping up around the country. Endo Pharma and Actavis have been named, as has AstraZeneca, Teva, Ranbaxy and Dr. Reddy's. And with the U.S. Supreme Court having defined its position this year, the pay-for-delay legal issue is being litigated under a whole new set of rules.
In the drug business, market exclusivity is king. Every branded business model is built on it. But what happens if your brand doesn't have exclusive market access? If you're Sanofi, preparing to launch over-the-counter Nasacort, you sue the FDA.
GlaxoSmithKline's Advair is hard to copy. Some companies have given up on generic Advair, while others have shied away altogether despite the substantial sales up for grabs. But what if generics makers had some help--and an expedited review process--from the FDA?
Mylan CEO Heather Bresch is looking forward to next year. After having red-hot earnings reports last year, the more lackluster results in 2013 have been a disappointment. The company reported a 25% drop in net profit and a 2% falloff in sales for its third quarter. But Bresch promises the generic drugmaker will return to form in 2014, and analysts are taking her at her word.