The U.S. solicitor general has urged the Supreme Court to review a Federal Circuit decision that requires some biosimilar makers wait six months after receiving FDA approval to launch a…

Six generics makers are facing a civil lawsuit for allegedly colluding to fix the prices of the antibiotic doxycycline hyclate and the diabetes drug glyburide. Source: Generic Line

Gilead will have to pay Merck $2.5 billion for infringing a patent that covers the active ingredient of its blockbuster hepatitis C drugs, Salvadi and Harvoni, in the country’s largest…

UK’s antitrust agency has accused Actavis of breaching competition law by raising the price of generic hydrocortisone tablets for Addison’s disease by more than 12,000 percent since 2008. Source: Generic…

The FDA has again updated guidance on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones…

Juno has filed a lawsuit against Kite Pharma for the alleged infringement of eight patent claims covering a cancer immunotherapy that uses a chimeric T cell receptor. Source: Generic Line

The U.S. Supreme Court has declined to hear a case on whether all biosimilar makers must give a six-month notice before bringing an FDA-approved product to market, even when disclosures…

Teva alleges six generics makers infringed a patent covering its multiple sclerosis therapy Copaxone when seeking approvals for copycat versions of the drug. Source: Generic Line

Generic approvals and rejections were little changed from November, remaining stable as ANDAs slightly fell in the second month of fiscal 2017. Source: Generic Line

A majority of patent settlements reached last year in the European Union restricted the market entry of generics, according to a European Commission report. Source: Generic Line