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

Orphan drug incentives, new technology and anxiety over expiring patents have dramatically spurred investment into biotech products, with the number of large molecule, biologic drugs in development tripling over the past decade. 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

Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More

Two new hepatitis C drugs expected to be approved in the coming weeks should drastically reshape the market and treatment of the disease. 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