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CDER plans to increase cooperation with European counterparts and make more use of databases as sources of safety data as it hones its approach to drug safety monitoring. Read More
The FDA approved Asklepion Pharmaceuticals’ Cholbam, the first treatment for children and adults with single-enzyme bile acid disorders and peroxisomal disorders, under its pediatric rare disease priority review voucher program. Under the terms Congress set for the program, the FDA must now phase it out within 12 months unless it is reauthorized. Read More
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
Sponsors of brand, generic and biosimilar drugs applying for marketing authorization through the EU’s centralized procedure must begin including facility inspection information in their applications. 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
China is opening its market to biosimilars, issuing the country’s first-ever guideline on the technical review of the products and criteria for establishing biosimilarity. 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