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The FDA is continuing its push to find ways to curtail opioid abuse, calling for suggestions and recommendations on innovative packaging, storage and disposal systems, technologies or designs that would thwart abusers. Read More
The FDA wants manufacturers of low molecular weight heparin (LMWH) products to do a better job of assessing immunogenicity risk before submitting their products for approval. 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
Takeda Pharmaceutical and Eli Lilly Monday were ordered to pay a combined $9 billion in punitive damages after a federal court jury found they hid the cancer risks of their Actos diabetes medicine. 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
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
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
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
Amgen’s investigational metastatic melanoma candidate talimogene laherparepvec met its primary endpoint of durable response in a Phase III clinical trial, but missed the secondary endpoint of overall survival, the drugmaker said. Read More