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Merck and Bristol-Myers Squibb are in danger of losing the breakthrough therapy designation for their hepatitis C drugs, in a first-ever move that could extend both drugs’ review times. Read More
Drugmakers designing trials for alcoholism treatments can use a primary endpoint of no heavy drinking rather than total abstinence, the FDA says, in an acknowledgement that abstinence as a goal in these studies is often unattainable. Read More
The FDA has warned an Oregon compounder for multiple GMP violations, including poor sterile drug manufacturing practices, using ingredients that aren’t FDA-approved and not receiving valid prescriptions for drugs it was producing. Read More
A suggested link between Novartis’ heart failure drug LCZ696 and progression of Alzheimer’s disease could sour hopes of a pipeline replacement for the company’s failed Reasanz heart drug. Read More
The European Medicines Agency has issued guidance to help drugmakers improve their responses to scientific objections lodged by EMA review committees. Read More
The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them, setting up a test case for the EU’s new trial transparency policy. Read More
Hospira is looking to add another biosimilar candidate to its growing pipeline by partnering with Pfenex to develop and market a biosimilar of Genentech’s retinal disease therapy Lucentis. Read More