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Regulations on off-label use are not harmonized across the European Union — only 10 out of 21 surveyed member states have specific policies, according to a European Commission report. Read More
The Association of the British Pharmaceutical Industry found four drugmakers — Celgene, Takeda, Vifor Pharma and Pierre Fabre — violated the group’s code of practice by engaging in activities ranging from inadequate quality management to deceptive drug promotion. Read More
The U.S. Court of Appeals for the Federal Circuit upheld a lower court decision that Sun Pharma did not infringe on Takeda’s patents when developing a generic version of Prevacid disintegrating tablets. Read More
In yet another pressure point on generic drug prices, a class action suit filed in a Pennsylvania federal court claims Actavis, Teva, Sandoz, Fougera and Taro conspired to fix the prices of fluocinonide creams and gels. Read More
A federal judge has ruled that a class-action antitrust lawsuit against several generics manufacturers, alleging price-fixing of propranolol capsules and tablets, can proceed in court. Read More
GlaxoSmithKline has asked the U.S. Supreme Court to rule on the proper jurisdiction for a suit over birth defects and its antidepressant Paxil. Read More
A federal judge ruled that three generics manufacturers infringed on Novartis’ patents related to its Zortress treatment, used during kidney and liver transplants. Read More
Three drugmakers have filed amicus briefs in support of Regeneron and Sanofi’s efforts to reverse a district court ruling that validated Amgen patents on Repatha and barred the companies from selling their cholesterol drug Praluent. Read More
South Korean biosimilars firm Celltrion is challenging the validity of four Genentech patents for combination therapies to treat metastatic breast cancer. Read More
An industry group and two drugmakers have filed briefs in the Supreme Court backing Amgen’s request that a federal circuit ruling be partially affirmed to mandate that biosimilar makers share information and wait six months after an FDA approval to launch a therapy. Read More