Drugs

Biopharmaceutical Innovation ‘Robust’: QuintilesIMS Report

A QuintilesIMS Institute report on “Lifetime Trends in Biopharmaceutical Innovation” says that from a numerical perspective and anticipating the progress of drug candidates currently in the research and development pipeline, the state of biopharmaceutical innovation is robust. The report says that a total of 667 innovative biopharmaceuticals launched in the U.S. over the past 20 years, “bringing new treatment options to both small and large groups of patients suffering from specific diseases.

The source of the biopharmaceutical innovation that is successfully launched in the U.S. is highly diverse, the report says, with over 300 entities filing original patents to protect the intellectual property that became the basis for the 667 medicines that were launched. “Nearly three-quarters of the molecules were launched by a company different from the one that filed the original patent, reflecting the level of activity in licensing, partnering, and acquiring associated with biopharmaceutical innovation.

The average time from original patent filing until U.S. launch for all molecules is 12.8 years, the institute says, with upper and lower quintiles of 16.3 and 8.2 years respectively. “Since 2008, the average elapsed time from patent filing to launch has declined with the most recent five-year cohort having declined by more than four years, or by 25%,” it says. “This brings the time from patent filing to launch for the most recently launched cohorts into line with the timing observed in the 1996-2002 period.”

According to the report, sales trends for medicines launched over the past 20 years are characterized by a relatively small number of outlier products with significantly higher sales than the majority of products. In each year, it says, the five drugs with the highest cumulative sales in their first five years on the market average 14 times higher than the rest of drugs launched that year.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome