A California judge has ruled that Sandoz must file an application with the FDA for approval of a biosimilar referencing Amgen’s biologic arthritis drug Enbrel before it can challenge the brand drug’s patents. Read More

Drugmakers are pushing back on proposed EU GMP requirements that would expand safeguards against product cross-contamination, saying the proposed six-month timeline for implementation is unworkable. Read More

Sanofi has decided to stop pursuing regulatory filing for its blood cancer drug fedratinib after new safety concerns arose from several clinical trials. Read More

A drug’s active ingredient name does not need to appear every time its brand name is repeated in an advertisement, the FDA says, clarifying the most common advertising issue that drugmakers question the agency about. Read More

The FDA says developers of next-generation heart drugs, known as PCSK9 inhibitors, will need to present data showing only their effectiveness at lowering cholesterol, blood pressure and inflammation, not reducing heart attack or stroke. Read More

The European Medicines Agency (EMA) has concluded a review of adverse event reporting deficiencies at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More

Twenty-five drugmakers have agreed to pay the state of Louisiana more than $88 million to settle Medicaid and Medicare fraud charges lodged against them as part of the state’s continuing crusade to recover funds paid out to drug companies improperly. Read More

Today’s regulatory culture is too risk-averse when it comes to drug approvals and risks keeping promising treatments off the market, senior officials at the European Medicines Agency say. Read More

In a new “sunshine” bid, Britain’s brand drugmakers will begin disclosing payments made to physicians in connection with the development or sale of medicines, beginning in 2016. Read More

The European Medicines Agency will accept premarket applications with limited data for antibiotics that target unmet needs, according to an amended guideline on developing antibacterial drugs for multidrug-resistant infections. Read More