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FDA officials indicated that the shortest median time to meaningful pain relief in the pivotal trial was 92 minutes — longer than the hour in which patients generally expect pain relief to take effect. Read More
Merck is appealing a decision that reinstated a class-action lawsuit alleging that the company failed to warn thousands of women taking Fosamax that they were at risk for thigh fractures. Read More
Spending on U.S. cancer medicines nearly doubled over the last five years—and may well double again in the next five years, a new report from IQVIA claims. Read More
The Trump administration is urging the Supreme Court to take up a case testing whether the FDA’s refusal to approve a warning label on drugs preempts state laws that may require such labels. Read More
Pfizer agreed to pay $23.85 million and enter into a five-year corporate integrity agreement to settle U.S. government claims that the company engaged in illegal kickbacks to Medicare patients that were masked by an independent charity. Read More
Developmental proposals “may be more convincing,” if the drug is shown to be safe and effective in the treatment of other relevant diseases, the agency said. Read More
Seniors covered by Medicare Part D are paying more for generic drugs even though the market prices remain stable, according to new research by Avalere, a healthcare consulting firm. Read More