A drug to treat low female sexual desire should be approved with strict measures in place to ensure patients are fully aware of its risks, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday. If approved, the drug would be the first to treat low sexual desire in women. The FDA […]

An experimental drug made by Sanofi SA and Regeneron Pharmaceuticals Inc effectively lowers bad LDL cholesterol and is generally well tolerated, according to a preliminary review by the U.S. Food and Drug Administration. The review was published on Friday before a meeting on Tuesday of a panel of outside advisers to the FDA who will […]

The U.S. biotechnology arena is undergoing a record-breaking M&A cycle for the industry. After generating M&A activity valued at $235 billion during 2014, the U.S. biotech sector produced more than $100 billion in deals during first-quarter 2015.

By John Kamp • Executive Director of the Coalition for Healthcare Communication So, you already know that the 300+ page bill which includes a broad array of amendments related to the National Institute of Health (NIH) and the Food and Drug Administration (FDA) passed out of the House Commerce Committee on May 21 by an […]

While development of personalized medicines has grown since the human genome was first sequenced in 2001, biopharmaceutical sponsors face a number of hurdles that are impeding more rapid market uptake, according to a recently completed study by the Tufts Center for the Study of Drug Development. Fourteen years after the human genome was initially sequenced, […]

CRANBURY, N.J., June 4, 2015 /PRNewswire/ — Palatin Technologies, Inc. (NYSE Amex: PTN) – Today’s FDA Advisory Committee’s recommendation for the approval of flibanserin is an important step forward in women’s health, as the decision addresses the important need for the women living with hypoactive sexual desire disorder, or HSDD, to have an approved treatment option. […]

RALEIGH, N.C., June 4, 2015 /PRNewswire/ — Today the U.S. Food and Drug Administration’s (FDA) joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee, and the Drug Safety and Risk Management Advisory Committee determined by an 18 to 6 vote that the benefit/risk profile of Sprout Pharmaceuticals’ ADDYI™ (flibanserin) supports FDA approval for Hypoactive […]

WASHINGTON, June 4, 2015 /PRNewswire-USNewswire/ — Even the Score today issued the following statement following a historic decision by an Advisory Committee of the Food and Drug Administration (FDA) to recommend approval of what would be the first-ever medical treatment option for women’s most common sexual dysfunction, Hypoactive Sexual Desire Disorder (HSDD). The Agency will […]

DUBLIN, June 4, 2015 /PRNewswire/ — Research and Markets (http://www.researchandmarkets.com/research/tldjc5/frontier_pharma) has announced the addition of the “Frontier Pharma: Asthma – Identifying and Commercializing First-in-Class Innovation” report to their offering.      (Logo: http://photos.prnewswire.com/prnh/20130307/600769 ) Biologics Growing in Prominence in Asthma Treatment: While the current asthma market is almost exclusively dominated by small molecules, which account for […]

DUBLIN–(BUSINESS WIRE)–Research and Markets (http://www.researchandmarkets.com/research/7dczrs/essential) has announced the addition of the “Essential Thrombocythemia – Pipeline Review, H1 2015” report to their offering. This report provides comprehensive information on the therapeutic development for Essential Thrombocythemia, complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and […]