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British health-payment authorities reversed course last week and cleared the way for the use of Astellas Pharma’s advanced prostate cancer drug Xtandi in men who already had been treated with Johnson & Johnson’s competitor product Zytiga. Read More
Teva is making a last-second attempt to delay generic versions of its multiple sclerosis drug Copaxone from hitting the market, asking a federal court to require ANDA seekers to submit more data. Read More
Two recently issued guidances that aim to clarify standards and electronic formats for regulatory filings have confused some drugmakers who say they need more detail on what types of applications the standards apply to and more time to implement potential format revisions. Read More
Manufacturers looking to speed up drug approvals in Europe, and ensure their products will be covered by payers, should initiate early parallel conversations with both the European Medicines Agency and the Health Technology Assessment Bodies (HTABs), the EMA says. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis and made available to patients sooner. Read More
AstraZeneca said the FDA has approved its fish oil-based cardiovascular drug Epanova (omega-3-carboxylic acids) for the treatment of adults with very high triglyceride levels. Read More
The FDA says there isn’t enough evidence to support marketing aspirin as preventing first-time heart attacks, meaning drugmakers will have to fund more studies if they want to change the agency’s mind. Read More
Longer-term clinical benefits associated with sustained soliris treatment include prevention of TMA and continued improvement in renal function. Read More