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Genentech filed a lawsuit aiming to stop Pfizer’s proposed Herceptin biosimilar from reaching the market — asking the court to compensate for losses in sales should the copy launch before 2019, when several patents are set to expire. Read More
The European Medicines Agency adopted a guideline for sponsors developing new products for autism spectrum disorder, providing recommendations on diagnostic criteria, target populations and clinical trial design. Read More
The FDA finalized guidance for manufacturers looking to produce generic versions of opioid painkillers with abuse-deterrent labeling, as a part of the agency’s push to lower overall exposure to opioids and prevent new addictions. Read More