Orphan-drug specialist, Sigma-Tau Pharmaceuticals Inc. is developing a new class of drugs: live biotherapeutics. As the name implies, Sigma-Tau’s drug candidate, STP206, is a live organism used to repopulate patients’ gastrointestinal tracks.
Last week, Cambridge, Mass.-based Aveo Oncology and Astellas Pharma Inc., of Tokyo, announced that they were discontinuing a Phase II trial testing tivozanib in patients with locally recurrent or metastatic triple negative breast cancer due to insufficient enrollment.
Nearly half of pharmaceutical companies can be found on social media websites according to a report by IMS Institute for Healthcare Informatics, but most use their accounts as a broadcasting channel with very little interaction with patients and doctors.
Last January, BioWorld Insight asked whether, after a long bumpy road, RNA therapeutics could prosper in 2013. With a few exceptions, the answer was a resounding yes. (See BioWorld Insight, Jan. 7, 2013.)
U.S. biopharmaceutical companies capped 2013 with the strongest quarter of the year, raising $835 million in 37 venture capital deals in the fourth quarter according to data compiled by BioWorld Snapshots.
The Compounding Quality Act, part of the Drug Quality and Security Act, signed into law last month, creates a volunteer registration of “outsourcing facilities” that will be subject to scrutiny by the FDA, including routine inspections.
Forest Laboratories Inc. joined the litany of big pharma companies announcing restructuring programs last week. But the major restructuring, dubbed Project Rejuvenate, appears to be more about streamlining operations than downsizing.
The FDA approved 35 new molecular/biological entities (NMEs/NBEs) on average in 2011-2012, substantially higher than the 20-year average of 28 approvals.
Adeno-associated virus (AAV)-based systems are ideally suited for delivering gene therapy. After the viral vector infects the cell, the DNA doesn’t integrate into the host genome, instead existing primarily in an episomal form, which allows for long-term expression in nonreplicating cells without DNA damage to the host cells and the risk of inducing malignancy.
