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The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies. Read More
The Federal Trade Commission filed an amicus brief in the case of Takeda v. Zydus, urging the U.S. District Court of New Jersey to reject the notion that patent infringement suits brought under a law governing generic drugs are exempt from antitrust scrutiny. Read More
Within weeks of the approval of Pfizer’s biosimilar in 2016, J&J implemented a plan to maintain its market share, according to the complaint. Read More
As part of its ongoing campaign against opioid-related fraud, the Justice Department unsealed a superseding indictment Thursday against a CEO and four doctors in connection with a conspiracy to write unnecessary prescriptions. Read More
Two major drug store chains sued Johnson & Johnson this week alleging the company strong-armed insurers out of covering biosimilars of its immunosuppressant drug Remicade (infliximab). Read More
Innovative antiretroviral HIV drugs may qualify for PDUFA fee waivers or refunds if the fee would be a significant barrier to development, according to new FDA draft guidance aimed at implementing the President’s Emergency Plan for AIDS Relief. Read More