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Weekly Drug News Round Up - February 12, 2014

FDA Investigates Possible Link Between Saxagliptin and Heart Failure

Patients should not stop taking saxagliptin but should direct questions to their health care provider Read More...

The U.S. Food and Drug Administration (FDA) has requested clinical data from the manufacturer of saxagliptin (Onglyza and Kombiglyze XR) to investigate a possible link between the use of the type 2 diabetes drug and heart failure. FDA requested information as part of a larger evaluation of all type 2 diabetes drug therapies and heart risk. A study published in the New England Journal of Medicine (NEJM) in September 2013 reported an increased rate of hospitalization for heart failure with use of saxagliptin. FDA considers the information from the NEJM study to be preliminary, and will communicate further information when available.

FDA Panel Says Naproxen Heart Safety Evidence Is Not There

An FDA advisory panel voted 16-9 saying they did not find enough evidence to upgrade naproxen’s heart warnings Read More...

Since 2005, labeling laws have required a heart warning on nonsteroidal antiinflammatory drugs (NSAIDs) stemming from an increased risk of heart attack. A U.S. Food and Drug Administration (FDA) advisory panel stated on Tuesday that the research is not strong enough to prove that naproxen (Aleve) is safer for the heart than other NSAIDs like ibuprofen (Advil, Motrin). A vote in favor of naproxen's superiority might have resulted in a label change claiming less heart risk for naproxen products. Although the FDA is not required to follow the recommendations of its advisory committees, it often does.

Imbruvica Gains New Indication for Chronic Lymphocytic Leukemia

Roughly 15,680 Americans were diagnosed and 4,580 died from CLL in 2013 Read More...

The U.S. Food and Drug Administration (FDA) has approved an additional use for Imbruvica (ibrutinib) to treat chronic lymphocytic leukemia (CLL) in patients who have received at least one previous therapy. Imbruvica is also approved for the treatment of mantle cell lymphoma (MCL), a rare and aggressive blood cancer. Imbruvica research in 48 patients showed over half of participants had their cancer shrink after treatment, with a duration of response ranging from 5.6 to 24.2 months. An improvement in survival or disease-related symptoms has not been established. Imbruvica fights CLL by blocking an enzyme that allows the cancer to grow and spread.

Q4 2013 Drug Sales Data Released: Tecfidera Growth On a Rapid Transit

Drugs.com has released the latest U.S. drug sales data Read More...

The Q4 2013 ranking of the top three drugs by sales — Abilify, Nexium and Humira — remains the same, but Lilly’s Cymbalta drops from fourth to seventh and forfeits close to $319 million in sales due to generic availability. Nexium’s growth tapers too, possibly due to looming patent loss and an up-and-coming Rx-to-OTC switch. Crestor, AstraZeneca’s top cholesterol drug with market exclusivity until 2016, slides up one notch to number four, and GSK’s Advair Diskus returns to round out the top five. Tecfidera, predicted to be a blockbuster in Biogen Idec’s multiple sclerosis portfolio, continues to gain strength with a 20 percent climb in sales.

Drugs.com and TrialReach Partner to Provide Access to Investigational Drugs

Clinical trials give patients the opportunity to participate in ground-breaking medical research and help other patients Read More...

The intersection of technology, data science and social media is creating an unparalleled opportunity to gather information and insights about drug development and testing. In response to this opportunity, Drugs.com, the leading online clinical drug resource, and TrialReach are partnering to provide patients with information and access to investigational treatments. Enrollment in a clinical trial can offer a patient more options, particularly when they have exhausted the standard medication protocols. This new partnership will bring TrialReach's patient-centric content and tools directly to the 25+ million people who visit Drugs.com every month.

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