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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
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
A federal judge upheld the FDA’s decision to strip Ranbaxy of its tentative ANDA approvals and first-filer rights to two drugs because of GMP problems at manufacturing facilities, but nonetheless blasted the agency, saying it never should have issued the approvals in the first place. Read More
Manufacturers of biosimilar insulin-containing products must demonstrate pharmacodynamic and pharmacokinetic similarity profiles to prove similar efficacy to their reference insulin, the European Medicines Agency says in final guidance. 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