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Two new analyses showing Gilead Sciences’ Sovaldi and Harvoni hepatitis C drugs are largely cost-effective could convince payers to cover the therapies, which — at roughly $7,000 and $7,875 per week, respectively — are the costliest drugs ever marketed in the U.S. Read More
A federal court agreed Tuesday to hear Mylan’s appeal in patent infringement litigation with AstraZeneca, in a case that could determine in which states brandmakers can file lawsuits against generic firms. Read More
With the FDA beginning to approve biosimilars, the next major hurdle for the emerging sector will be in the courts, where brandmakers and would-be competitors are arguing over how they will approach patent infringement lawsuits, especially when it comes to sensitive manufacturing data. Read More
A federal appeals court has extended an injunction barring four companies from marketing generic versions of AstraZeneca’s blockbuster inhaled asthma drug Pulmicort Respules while it hears an appeal of a lower court ruling that invalidated the brandmaker’s patent on the drug. Read More
Gilead Sciences has ratcheted up efforts to get the Supreme Court to hear a double patenting lawsuit, arguing the Federal Circuit’s ruling invalidating patent protection for its influenza drug Tamiflu effectively rewrites the obviousness-type double patenting doctrine. Read More
CorePharma will divest generic rights to a dry mouth therapy and a liver drug to clear the way for Impax’s $700 million acquisition of the Middlesex, N.J., drugmaker. Read More
A federal judge has ordered Reckitt Benckiser to release documents the company wanted to suppress in an ongoing FTC probe into allegations the company illegally delayed generic competition to its opioid-dependence treatment Suboxone. Read More
Generics maker Natco Pharma has signed an authorized generic licensing deal with Gilead to produce its pricey blockbuster hepatitis C drug Sovaldi in India and 90 other developing countries. The agreement likely signals an end to Natco’s fight to have Sovaldi’s patent protection in India revoked. Read More
A federal judge has sided with a Paragraph IV ANDA from Teva and struck down the patents protecting Actavis subsidiary Warner Chilcott’s postmenopausal osteoporosis drug Atelvia. Read More
India’s patent office has sided with a challenge from generics maker Cipla and struck down a patent protecting Boehringer Ingleheim’s blockbuster COPD drug Spiriva. Read More
Generics maker Sandoz will pay out $12.64 million to settle accusations it misrepresented average sales price information in reports to Medicare. Read More
The FTC is fighting to keep secret the reports drugmakers must file with the commission on patent infringement litigation in an ongoing and closely watched pay-for-delay lawsuit with Actavis. Read More