The Food and Drug Administration will hold a meeting in June to reassess the safety of GlaxoSmithKline's former blockbuster drug Avandia, which was severely restricted in 2010 due to concerns about its impact on the heart. Regulators announced the highly unusual move in a recent government notice.
The appeal of cell culture–based production of drugs has increased demand for single-use bioreactors that can move into the process-development lab and help manage peaks and tight development schedules. Single-use bioreactors can be used for monoclonal antibodies, recombinant proteins, stem cells, and vaccines.
The U.S. Food and Drug Administration cannot determine whether its four-year-old Risk Evaluation and Mitigation Strategies program is working because drug companies have not provided key information when requested and the agency has not taken enforcement action against them.
Apoptosis, or programmed cell death, plays an essential role in organismal development and tissue homeostasis. During development, apoptosis is critical for the sculpting of organs and the elimination of unnecessary structures. Many cells die an altruistic death daily to secure homeostasis of the whole organism.
Tumor necrosis factor can actually heighten susceptibility to tuberculosis if its levels are too high. A study shows how excess production of this disease-cell destroyer at first acts as a TB germ killer. But later the opposite occurs: too much tumor necrosis factor encourages TB pathogens to multiply in the body.
A key function of heat shock proteins (HSPs) is to act as molecular chaperones to assist in the folding and stabilization of numerous client proteins. One family of HSPs—heat shock protein 90—stabilizes a diverse range of client proteins, many of which are involved in key pathways in malignancy.
The neverending din of partisan squabbling coming out of Washington can be deafening at times. Luckily for everyone, legislation like The Food and Drug Administration Safety and Innovation Act of 2012 seemed more or less immune to this cacophony, passing the Senate with 92 yay votes.
Bristol-Myers Squibb has announced a $250 million expansion of its central Massachusetts manufacturing complex that will eventually employ an additional 350 workers. The expansion will add space for developing biologics and for manufacturing those products for clinical trials.
The day-to-day pressures on a compound manager come from several directions. There is pressure to support the increasing demands for samples in more diverse delivery formats; pressure to keep operational and supply costs down; and there has been the unfortunate trend toward staff reductions.
Scientists recently demonstrated that biphasic vesicles can deliver large-molecule or macromolecule drugs into the skin. Success with biphasic vesicles offers the potential for needle-free administration of many pharmaceuticals that could previously only be administered by injection.
Eli Lilly plans to cut hundreds of workers from its U.S. sales force as the drugmaker prepares to deal with the loss of patent protection for two more top-selling drugs. Lilly spokesman Scott MacGregor declined to disclose the specific number of cuts, but did say it totals less than 1,000 full-time employees.
Predicting the side effects of drugs remains one of the industry’s greatest challenges, with a large percentage of new drugs failing in clinical studies due to cardiac toxicity. The overall success rate from Phase 1 studies is only 11%, with 30% of these failing for safety reasons.
Available in both immersion probe and flow through styles, these compact systems are ideal for cooling exothermic reactions, freeze point determinations, freeze drying, impact testing, lyophilization, and vapor and solvent trapping.
Biosearch Technologies Inc. has announced the acquisition of exclusive worldwide rights to continuing Stellaris RNA FISH-based inventions from the University of Medicine and Dentistry of New Jersey.
SPOT Imaging Solutions has released the ultra-sensitive SPOT Pursuit USB digital camera. The SPOT Pursuit camera combines high image quality with excellent temporal resolution for rapid time-lapse recordings, allowing researchers to document live cells and photobleaching fluorescence specimens with ease.