Although approvals for orphan drugs have increased at a blistering pace in the U.S. and Europe, the cost of those drugs represents a growing challenge for patients and payers, according to a study conducted by the Center for the Study of Drug Development (CSDD) at Tufts University.
Salix Pharmaceuticals Inc. put another smile on the faces of investors with word from the FDA that subcutaneous Relistor (methylnaltrexone bromide) is approvable in opioid-induced constipation (OIC) for chronic non-cancer pain based on the data submitted in the supplemental new drug application (sNDA).
Suzhou Alphamab Co. Ltd. is among the new generation of Chinese biopharmas moving rapidly along the evolutionary curve from contract research activities such as high-throughput screening, analytical biology and process development to the construction of a pipeline of biosimilars and, most recently, the development of novel compounds directed at cancer, autoimmune and infectious diseases.
For more than five years, the FDA was criticized for failing to provide clear guidance on how drug developers could use social media without running afoul of its marketing restrictions. Last month, the agency finally came through with two crucial draft guidances. A webinar Thursday afternoon aimed at providing more color around the social media regulatory framework could only be described as an #EPICFAIL. The webinar, for which registration reportedly closed early due to overwhelming demand, suffered problems from the get-go, with many registrants unable to log in at all. Almost immediately, slides started crashing, prompting the agency to pause...
The ongoing effort to modernize clinical trials through the 21st Century Cures initiative came before the Subcommittee on Health of the House of Representatives Energy and Commerce Committee Wednesday morning in the first of a two-part hearing.
Mark Surber, president and CEO of Genoa Pharmaceuticals Inc., has witnessed firsthand the devastation wrought by idiopathic pulmonary fibrosis (IPF), a lung disease linked both to genetic and environmental factors that results in progressive lung scarring.
Viking Therapeutics Inc. became the fourth biopharma during first three days of the third quarter to indicate its intention to plumb the public markets with an initial public offering (IPO). San Diego-based Viking filed an S-1 with the SEC seeking to raise up to $57.5 million, including overallotments, for the offering, which is not yet priced.
Roche AG unit Genentech is plunking down $725 million in cash, plus contingent milestone-based payments of up to $1 billion, to purchase Seragon Pharmaceuticals Inc. and its portfolio of oral selective estrogen receptor degraders (SERDs), designed to treat hormone receptor-positive breast cancer.
Shares of Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) got a boost Tuesday on word that a third phase III trial, TARGET 3, met its primary endpoint with statistical significance.
SAN DIEGO – What's the value equation for the cost of cancer therapy, and what portion of that cost should public and private payers bear? The topic – an important one for patients and drug developers alike – was the intriguing premise of a session on the final day of the BIO International Convention.
