The FDA approved 39 new drugs in 2012, the highest since 1996, so it should come as no surprise that regulatory affairs and clinical development experts are in high demand these days.
Liposome nanoparticles have been in existence for nearly two decades. Doxil (doxorubicin liposomal), developed by Sequus Pharmaceuticals Inc., gained FDA approval in 1995. But liposomes have limited use because it's hard to target them to specific tissue and there are very few drugs that can be loaded into and released from liposomes.
Last month, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion of the marketing authorization application for Kynamro (mipomersen), developed by Isis Pharmaceuticals Inc. and Genzyme Corp., a unit of Sanofi SA, for the treatment of homozygous familial hypercholesterolemia (HoFH). Genzyme is appealing the decision, which should be completed in the second quarter of 2013.
There's a large $2 billion market for over-the-counter products to treat the roughly 39 million Americans with lactose intolerance, but even with the available options, 82 percent of lactose-intolerant patients report they still experience symptoms.
"I absolutely believe there will be an RNAi drug [on the market] within 10 years," Nassim Usman, COO and senior VP, Sirna Therapeutics Inc., said in a 2005 interview for BioWorld's RNAi Report.
Whether it's Congress making decisions or venture capitalists making investments, leaving things to the last minute seems to be all the rage these days.
Cox Proportional Hazard Models are nothing new to those who follow oncology drugs where the statistical analysis is used to calculate survival effects of drugs. But the Alliance Life Sciences Consulting Group Inc. put an interesting twist on the statistical analysis, using it to determine what factors affect the price changes of oncology drugs.
The Generating Antibiotic Incentives Now (GAIN) section of the Food and Drug Administration Safety and Innovation Act (FDASIA) lists some pathogens that can qualify antibiotics for new incentives, but left open the possibility of adding additional pathogens to the list.
As biotech executives look to get off the treadmill of financing their companies from milestone to milestone, at-the-market (ATM) offerings have become more popular. According to Brinson Patrick Securities Corp., use of ATM offerings by life sciences companies reached a record high in the third quarter.
Last year was rather rough for Xoma Corp. In March 2011, the company saw its interleukin-1 beta inhibitor gevokizumab miss its primary endpoint in a Phase IIb trial in Type II diabetes, eliminating the opportunity to enter the lucrative market. (See BioWorld Today, March 24, 2011.)
