As interest and investment in biopharmaceuticals grows, the pressure to innovate and rapidly deliver new therapies increases. While many avenues may be pursued, the high cost of developing biological molecules increases the need to advance only those therapies with the greatest likelihood of becoming manufacturable, efficacious, safe and profitable products.
Awareness of the benefits of gravimetric sample preparation has increased significantly over the past couple of years. Recognition of this state-of-the-art technology by industry organizations such as the United States Pharmacopeia (USP) has supported this trend. A recent revision to USP chapter 1251 “Weighing on an Analytical Balance” included a detailed description of the steps involved in gravimetric dosing for sample preparation.
The U.S. National Institutes of Health and numerous biopharmaceutical companies and disease foundations have teamed up on an unusual project to find and bring new medicines to patients faster. The Accelerating Medicines Partnership, announced Tuesday, will focus on the early part of drug research.
Researchers at Oregon State Univ. have discovered a genetic function that helps one of the most important “tumor suppressor” genes to do its job and prevent cancer. Finding ways to maintain or increase the effectiveness of this gene—called Grp1-associated scaffold protein, or Grasp—could offer an important new avenue for human cancer therapies, scientists said.
The Food and Drug Administration said Friday it is reviewing the safety of popular testosterone drugs for men in light of recent studies suggesting they can increase the risk of heart attack, stroke and death. A study suggested testosterone therapy could double the risk of those problems in men older than 65. Another study published in November found that the hormone increased the risk by 30%.
Cancer drugs that recruit antibodies from the body’s own immune system to help kill tumors have shown much promise in treating several types of cancer. However, after initial success, the tumors often return. A new study from Massachusetts Institute of Technology reveals a way to combat these recurrent tumors with a drug that makes them more vulnerable to the antibody treatment.
Drugmaker Merck & Co. is joining two dozen other pharmaceutical companies and contract laboratories in committing to not use chimpanzees for research. The growing trend could mean roughly 1,000 chimps in the U.S. used for research or warehoused for many years in laboratory cages could be "retired" to sanctuaries by around 2020.
Researchers from North Carolina State Univ. have developed a de facto antibiotic “smart bomb” that can identify specific strains of bacteria and sever their DNA, eliminating the infection. The technique offers a potential approach to treat infections by multi-drug resistant bacteria.
Researchers have discovered a potential treatment for a viral infection that causes potentially fatal brain swelling and paralysis in children. The findings also point to possible treatments for related viruses including those that cause common cold symptoms. The virus, called enterovirus 71 (EV71), causes yearly outbreaks of hand, foot and mouth disease in Southeast Asian countries, including China and Malaysia.
One of every 10 clinical trials for adults with cancer ends prematurely because researchers can't get enough people to test new treatments, scientists report. The surprisingly high rate reveals not just the scope and cost of wasted opportunities that deprive patients of potential advances, but also the extent of barriers such as money, logistics and even the mistaken fear that people won't get the best care if they join these experiments.
Using a novel high-throughput screening process, scientists have, for the first time, identified molecules with the potential to block the accumulation of a toxic eye protein that can lead to early onset of glaucoma. Glaucoma is a group of diseases that can damage the eye’s optic nerve and cause vision loss and blindness. Elevated eye pressure is the main risk factor for optic nerve damage.
Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the U.S. Food and Drug Administration (FDA). But a new study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.
Brian imaging experiments have revealed for the first time how ecstasy produces feelings of euphoria in users. The findings hint at ways that ecstasy, or MDMA, might be useful in the treatment of anxiety and post-traumatic stress disorder. MDMA has been a popular recreational drug since the 1980s, but there has been little research on which areas of the brain it affects.
Scientists at The Scripps Research Institute have demonstrated the power of a new drug discovery technique, which allows them to find, relatively quickly and cheaply, antibodies that have a desired effect on cells. The TSRI scientists used the technique to discover two antibodies that protect human cells from a cold virus.
As concerns about bacterial resistance to antibiotics grow, researchers are racing to find new kinds of drugs to replace ones that are no longer effective. One promising new class of molecules called acyldepsipeptides, ADEPs, kills bacteria in a way that no marketed antibacterial drug does. Now, researchers have shown that giving the ADEPs more backbone can dramatically increase their biological potency.
Nearly 8 million Americans suffer from post traumatic stress disorder (PTSD), a condition marked by severe anxiety stemming from a traumatic event such as a battle or violent attack. Many patients undergo psychotherapy. However, Massachusetts Institute of Technology neuroscientists have now shown that they can extinguish well-established traumatic memories in mice by giving them a type of drug called an HDAC2 inhibitor.
A panel of federal experts has recommended approval for an experimental blood thinner from Merck despite serious side effects including internal bleeding. The Food and Drug Administration's panel of cardiology experts voted 10-1 Wednesday in favor of approving the pill vorapaxar to help prevent blood clots in patients with a history of heart attacks.
Researchers at the Univ. of Delaware have developed a “smart” hydrogel that can deliver medicine on demand, in response to mechanical force. Over the past few decades, smart hydrogels have been created that respond to pH, temperature, DNA, light and other stimuli.
A world of cloak-and-dagger pharmaceuticals has come a step closer with the development of stealth compounds programmed to spring into action when they receive the signal. Researchers in the U.K. have designed and tested large molecular complexes that will reveal their true identity only when they’ve reached their intended target, like disguised saboteurs working deep behind enemy lines.
Scientists from the Florida campus of The Scripps Research Institute have described a pair of drug candidates that advance the search for new treatments for pain, addiction and other disorders. The two new drug scaffolds offer researchers novel tools that act on a demonstrated therapeutic target, the kappa opioid receptor (KOR), which is located on nerve cells and plays a role in the release of the neurotransmitter dopamine.
Duke Univ. scientists have taken aim at what may be an Achilles' heel of the HIV virus. Combining expertise in biochemistry, immunology and advanced computation, researchers at Duke have determined the structure of a key part of the HIV envelope protein, the gp41 membrane proximal external region (MPER), which previously eluded detailed structural description.
Vaccines combat diseases and protect populations from outbreaks, but the life-saving technology leaves room for improvement. Vaccines usually are made en masse in centralized locations far removed from where they will be used. They are expensive to ship and keep refrigerated and they tend to have short shelf lives. However, Univ. of Washington engineers have developed hope for on-demand vaccines.
A compound derived from a traditional Chinese herbal medicine has been found effective at alleviating pain, pointing the way to a new non-addictive analgesic for acute inflammatory and nerve pain, according to Univ. of California Irvine (UC Irvine) pharmacology researchers. Working with Chinese scientists, the UC Irvine team isolated a compound called dehydrocorybulbine (DHCB) from the roots of the Corydalis yanhusuo plant.
Researchers say vitamin E might slow the progression of mild-to-moderate Alzheimer's disease—the first time any treatment has been shown to alter the course of dementia at that stage. In a study of more than 600 older veterans, high doses of the vitamin delayed the decline in daily living skills, such as making meals, getting dressed and holding a conversation, by about six months over a two-year period.
Can an experimental drug developed to treat epilepsy block the AIDS virus? A preliminary lab study suggests it's possible, and researchers are eager to try it in people. When tested in human tissues in the laboratory, the drug "works beautifully" to prevent HIV from destroying key cells of the immune system.