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Teva Pharmaceuticals asked U.S. Supreme Court Chief Justice John Roberts to recall and stay a July 2013 appeals court ruling invalidating a patent on Teva’s blockbuster multiple sclerosis drug Copaxone, pending the full court’s final decision on the patent case. Read More
Congress is considering new legislation to require the Drug Enforcement Agency to speed up the process of scheduling a drug as a controlled substance and give drugmakers a firm timeline for agency decisions. Read More
The UK’s pharma regulator Monday began accepting applications for its Early Access to Medicines Scheme to allow not-yet-approved drugs for life-threatening diseases quicker interim approvals so they can be distributed to patients. Read More
Drugmakers decried the FDA’s push for sponsors of new chronic pain treatments to submit more safety data, calling it inconsistent and confusing. Read More
Genzyme will resubmit its application for an expanded indication in relapsing multiple sclerosis for Lemtrada during the second quarter, following “constructive” talks with the FDA, the company said Monday. Read More
Two new challenges emerged last week to the controversial drug Zohydro ER, as Vermont became the second state to slap restrictions on the drug and U.S. Attorney General Eric Holder announced he would look into the way the FDA approved the product. Read More
Mylan is accusing Celgene of violating federal antitrust law by prohibiting the generic drugmaker from obtaining samples of its blockbuster products Thalomid and Revlimid to make generic versions. Read More
With the FDA facing charges of indifference to the problem of opioid abuse, the agency Thursday recast itself as proactive on the issue, announcing approval of a consumer-friendly new injector that treats opioid overdose. Read More