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Days after the White House announced a new precision-medicine initiative, an influential group of US lawmakers has released its own wish list for biomedical research. On 27 January, several members of the House of Representatives released the first draft of their long-anticipated proposalto speed the translation of research into medicine. The effort, known as 21st Century Cures,…
Learn MoreDecember 30, 2014
I first Met Freda Lewis-Hall, M.D., on May 5, 2011, in New York. Pfizer’s chief medical officer had just concluded her Healthcare Businesswomen’s Association (HBA) Woman of the Year (WOTY) acceptance speech in which she challenged attendees to recommit, reenergize, and reform themselves to “be everything the patients we serve need us to be, and…
Learn MoreDecember 19, 2014
Representatives from the pharmaceutical and biotechnology industries said last Friday (Dec. 12) they expect work on the bipartisan 21st Century Cures initiative this spring to be a staging ground for negotiations over the sixth iteration of the Prescription Drug User Fee Act (PDUFA) in 2016 and 2017. Industry leaders also said they expected the biotechnology…
Learn MoreDecember 3, 2014
More than 60% of US prescriptions for cancer drugs call for using the medicines in ways that are not approved by the government. Often, they are the only hope against a fatal illness that has thwarted conventional treatments. But although such ‘off-label’ use is common, it is hard to know how effective it is because…
Learn MoreDecember 2, 2014
FDA’s evaluation of the first two years of the breakthrough therapies program found common threads among designation requests that were granted and denied, which may help sponsors better understand the agency’s criteria for awarding the incentive. Below are key characteristics of products that have gained and were denied breakthrough designation, as well as reasons why…
Learn MoreDecember 1, 2014
FDA is looking to standardize how it chooses drugs for the breakthrough approval pathway, and an early analysis of the handful of drugs chosen shows the most important criteria is that the therapy show a “spectacular advance in the field” over the typical improvement in drug development, drug center chief Janet Woodcock recently told an…
Learn MoreNovember 25, 2014
Medicare officials are evaluating new approaches to finding the most effective cures for cancer. Researchers developing more targeted therapies are anxious to see whether cancer drugs approved for use in one part of the body might be useful if a similar form of the disease appears elsewhere. Medicare data indicates that on average about 1…
Learn MoreOctober 30, 2014
FDA’s biologics center grants accelerated approval to the first U.S. vaccine targeting serogroup B meningococcal disease after a 4.5-month review; the vaccine is expected to come up for discussion, but not a vote, at CDC’s Advisory Committee on Immunization Practices meeting Oct. 30. FDA clearance of Pfizer Inc.’s meningococcal group B vaccine Trumenba marks the Center for Biologics…
Learn MoreOctober 20, 2014
A conversation on the past, present and what the future holds for battling disease. With billions of dollars being spent in research and development each year, with thousands of grassroots and fundraising events focused on curing cancer being held each year, with science and technology rapidly evolving in every part of our lives, many Americans,…
Learn MoreOctober 10, 2014
The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs…
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