Strategies & Technologies Driving Drug Discovery to Market
FDA Reassessing Avandia Risks
April 12, 2013 5:16 pm | by Matthew Perrone | News | CommentsThe 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.
Broader Bioreactor Applications
April 12, 2013 4:31 pm | by Mike May, Contributing Editor | Articles | CommentsThe 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.
Questioning the Value of REMS
April 12, 2013 3:59 pm | by Ted Agres, Contributing Editor | Articles | CommentsThe 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.
Quantifying Apoptosis Via High-throughput Screening
April 12, 2013 3:49 pm | by David Guffey, MS, Senior Technical Service Consultant; Roche Diagnostics, Indianapolis | Articles | CommentsApoptosis, 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.
TNF Jekyll and Hyde in Tuberculosis
April 12, 2013 11:04 am | News | CommentsTumor 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 Heat Shock Protein 90 Inhibitor for Advanced Refractory Solid Tumors
April 12, 2013 10:09 am | by John Lyons, PhD, Vice President, Translational Research and Development; Gavin Choy, PharmD, Vice President, Clinical Sciences and Operations; Amarpal Sahai, Senior Medical Writer; Mohammad Azab, MD, Chief Medical Officer; Astex Pharmaceuticals | Articles | CommentsA 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.
Coming Up Short
April 12, 2013 9:54 am | by Peter Bennett, Editor | Articles | CommentsThe 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.
BMS to Expand Biologics Operation
April 12, 2013 6:37 am | News | CommentsBristol-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.
Tackling the Challenges of Compound Management
April 11, 2013 4:50 pm | by David Booth, Regional Sales Manager (Europe); Titian Software Ltd., London | Articles | CommentsThe 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.
Dermal Delivery of Large-molecule Drugs
April 11, 2013 4:31 pm | by Bob Bruno, Principal; R.P. Bruno and Associates | Articles | CommentsScientists 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.
Lilly Cutting Sales Staff
April 11, 2013 4:05 pm | News | CommentsEli 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.
Assessing Cardiac Toxicity Using Stem Cell-derived Cardiomyocytes
April 11, 2013 4:02 pm | by Oksana Sirenko, Research Scientist; Carole Crittenden, Application Scientist; Evan F. Cromwell, Director of Assay Development; Molecular Devices LLC, Sunnyvale, Calif. | Articles | CommentsPredicting 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.
Polyscience Releases Low-cost Coolers
April 11, 2013 12:34 pm | Product Releases | CommentsAvailable 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 Adds RNA FISH-based Technologies
April 11, 2013 12:31 pm | Product Releases | CommentsBiosearch 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.
Live-cell Imaging Camera Has High Acquisition Rate
April 11, 2013 12:23 pm | Product Releases | CommentsSPOT 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.
