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A Chinese API maker relied on manipulated data and incomplete records to make decisions on batch releases, prompting the FDA to issue a warning letter to the company over data integrity. Read More
The EMA’s Committee for Medicinal Products for Human Use recommended approvals for six drugs within the EU to treat a range of conditions from an endocrine disease to nausea. Read More
The UK’s antitrust regulator alleges that Actavis and Concordia entered a pay-for-delay agreement to block the market entry of generic versions of hydrocortisone tablets and fix prices. Read More
China’s Ministry of Human Resources and Social Security has expanded the list of drugs covered by state insurance, adding more than 300 drugs to the catalog since it was last updated in 2009. Read More
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 an 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
New Jersey federal judges validated patents on Sunovion Pharmaceuticals’ schizophrenia drug Latuda and Helsinn’s nausea therapy Aloxi, dealing a blow to sponsors looking to launch generic versions of the drugs. Read More
In a loss for Shire, a three-judge panel for the U.S. Court of Appeals for the Federal Circuit ruled Actavis did not infringe a patent covering the ulcerative colitis drug Lialda, reversing a lower court decision. Read More
The U.S. solicitor general, the biosimilar industry, and several generics makers have filed U.S. Supreme Court briefs in support of reversing a Federal Circuit ruling that orders sponsors to wait six months after an FDA approval to launch a biosimilar. Read More
Twenty states have joined an antitrust lawsuit accusing six generics makers of colluding to fix the price of generic versions of antibiotic doxycycline hyclate and the diabetes drug glyburide. Read More