FDA approves Hi-Tech’s generic Floxin
WASHINGTON The Food and Drug Administration has granted approval to Hi-Tech Pharmacal for its application for ofloxacin otic solution, 0.3 percent.
The drug, which is a generic version of Daiichi Sankyo’s Floxin otic solution, is used to treat bacterial infections of the ear.
Daiichi Sankyo had tried to validate its patent in courts last July, but lost the appeals court ruling, which opened the market up for generic competition.
Floxin had sales of $105 million in 2007, according to IMS Health.
Study offers insights into cell growth ‘on/off’ switch
DURHAM, N.C. According to a study published in the April issue of the journal Nature Cell Biology, new information has been found about an on-off switch that controls cell growth could one day help identify targets for drugs to treat cancer and other diseases that involve unnatural cell growth.
If the switch is “on,” then a cell will divide, even if it’s damaged or the signal to grow disappears, according to researchers at the Duke Institute for Genome Sciences and Policy.
The on-off switch is part of the pathway that controls cell division, the process that creates new cells. Before a cell divides, it goes through a checklist to make sure everything is in order. If the cell senses a problem early on, it can halt the process. But once the cell passes what’s called the restriction point, it can no longer stop division. This on-off switch controls the restriction point and therefore plays an important role in cell growth, according to the study.
Biotech firms spent $58.8 billion on R&D in 2007
SAN FRANCISCO According to an analysis by Burrill and Company and the Pharmaceutical Research and Manufacturers of America, the biotech industry’s investment into research and development of new medicines was $58.8 billion in 2007.
The report also showed the PhRMA-member companies spent about $44.5 billion on research and development last year by themselves; this was a slight increase from the record number of 2006 which was $43 billion. Non-PhRMA companies spent about $14.3 billion, up from $12.2 billion in 2006.
“America’s biopharmaceutical research companies continue to pave the way for the development of future treatments and cures,” said PhRMA president and chief executive Billy Tauzin. “Simply put, R&D is the lifeblood of U.S. pharmaceutical innovators. Last year’s investment builds on over 25 years of growth in R&D spending as our researchers continue the search for new and improved therapies to tackle a wide range of diseases and conditions such as cancer, heart disease, HIV/AIDS and Alzheimer’s.”