As pharmaceutical and diagnostics companies seek to provide patients with effective and targeted therapies, they’re relying more heavily on genomics based biomarker discovery. Expression profiling studies offer just such a solution for discovering new disease and drug-response biomarkers. The question is where to begin.
Antibodies play a part in many aspects of today’s drug discovery and development. These...
Unanticipated cardiotoxicity is a leading cause of market withdrawal and late-phase attrition....
Bioisosteres are functional groups which have similar...
Inventors and their legal teams accepted sweeping changes in March, when longstanding U.S. laws granting patent rights to “the first-to-invent” were largely replaced by laws granting patent rights to “the first-inventor-to-file.” With ever-increasing patent filings in the United States, the shift brings the country in line with others—especially in Europe—where “first-to-file” has been in place for decades.
Not only is it getting harder and more expensive to bring a drug to market, it now appears that newer drugs are far less effective than those developed 40 or 50 years ago. A new study concludes that drugs tested in placebo-controlled clinical trials in 1971-80 were more than 4.5 times as effective as placebo in treating their primary outcomes, whereas drugs tested in 2001-10 were only 36 percent more effective than placebo.
Diabetes prevention has become a key focus area for the drug development market. Diabetes currently affects 366 million people worldwide and is expected to affect 552 million by 2030. According to the Schulze Diabetes Institute over $100 billion is spent annually by patients treating their diabetes. North America accounts for the highest share of the diabetes drug market, followed by Europe.
Microfluidics covers most any technology that handles- in an extremely precise and controlled way- very small volumes of fluids. The volumes tend to be controlled in microliter quantities or less. Since microfluidics birth in the1960s and 70s, many microfluidics-based platforms have come on the market.
In order to add assurance that the biosimilar candidate is as similar to the originator as possible, multiple tests should be used to assess similar qualities, an approach termed as “orthogonal” in the U.S. Food and Drug Administration draft biosimilar guidelines.
The drug discovery business is changing rapidly. More pharmaceutical companies are working with smaller biotech firms to create early-stage compounds, and thus need quicker and standardized solutions to early-stage development problems.
A positive genotoxicity result can throw the fate of a promising drug candidate—in which a firm has invested significant time and money—into doubt. The statistical improbability and challenges of bringing a drug to market become paramount.
Cancer is a disease of dysregulated cellular growth and signaling characterized by the loss or gain of function—through mutation or epigenetic change—of important regulatory proteins and cellular processes. Foremost among these is the tumor suppressor protein known as p53.
As the U.S. Food and Drug Administration finalizes regulations to establish a pathway for approving biopharmaceutical or biosimilar drugs, branded drug manufacturers are looking ahead and lobbying state legislatures to enact laws that would limit the substitution of biogenerics for brand-name drugs.
Moving from manual to automated histology expands the data available in drug research. Traditional pharmaceutical industry methods for bringing a drug to market require extensive studies with tissues or tissue microarrays, often manually read.
The industry has changed a great deal over the last decade and will continue to evolve in the coming years. In order to survive the multitude of technological, political, and regulatory changes that will no doubt arise, the biopharmaceutical industry must prove its adaptability.
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.
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.
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.
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.
Drug discovery and development depends increasingly on imaging, from traditional microscopy to high-content screening. Moreover, these techniques provide sophisticated capabilities. To make the most use of these tools, researchers need advanced software that provides automation, analysis, and ease-of-use.
New ideas from new places are critical to helping the industry pull back from the brink and get on stable footing. The only mistake here was waiting until the situation reached this point before taking advantage of these promising new avenues.
Less than 1% of current drugs have a companion diagnostic, and 60% of the drugs in clinical trials have a companion diagnostic in mind. Companion diagnostics are an important component in moving the ball forward in personalized medicine and making those moves depends on biomarkers.
As the New Year progresses, drug manufacturers are seeking to navigate changing—and increasingly stringent—governmental, financial, and commercial environments. Several recent studies and reports provide useful data and insights. The average cost of developing a new drug has jumped tenfold.
Since the isolation and propagation of the first immortalized cell line some 60 years ago, a multitude of relevant cell types and lineages now serve as a cornerstone in scientific research. However, as the “toolbox” grows so does our understanding of potential shortcomings in these models.
A drug entering the body undergoes a series of biotransformations via phase I and phase II metabolic pathways. The metabolites produced have a similar chemical structure to the parent drug and are more pharmacologically active at the therapeutic receptor sites.
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