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The FDA needs to hold more presubmission meetings with generic drugmakers on topics such as stability, batch size and drug release specifications to speed up the ANDA approval process, industry representatives say. Read More
Alkermes says its once-monthly injectable version of the antipsychotic blockbuster Abilify met its endpoints in a Phase III trial, setting it up for an NDA filing with the FDA sometime in the third quarter. Read More
Drugmakers and non-profit collaborators are releasing the results of failed cancer trials so that researchers can examine the datasets to look for signals or other useful information that may suggest new research directions. Read More
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
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
Zogenix Monday sought a temporary restraining order against Massachusetts Gov. Deval Patrick’s recent executive order prohibiting use of the prescription pain drug Zohydro ER in the state. Read More
While the FDA sees great potential for Bayesian statistics in Phase II clinical trials, the agency is not yet ready to endorse the method for Phase III studies. Read More
GlaxoSmithKline alerted consumers that five lots of its OTC weight loss drug Alli may have been tampered with after fielding complaints that a different drug was in some of the bottles. Read More
To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities, Commissioner Margaret Hamburg says. Read More
Halozyme has temporarily halted another trial due to safety concerns. This time, the drugmaker decided to hit the brakes after patients treated with PEGPH20, a pegylated form of its anti-cancer enzyme rHuPH20, showed increased risk for certain blood clots. Read More