A new study has found that many people who stopped taking cholesterol-lowering statin drugs were also taking an average of three other drugs that interfered with the normal metabolism of the statins. The other drugs can contribute to a common side effect of taking statins—muscle pain—and often led people to discontinue use of a medication that could otherwise help save their life, researchers learned.
A potential rheumatoid arthritis treatment from French drugmaker Sanofi and its U.S. development partner Regeneron Pharmaceuticals Inc. fared better than a fake drug at improving disease signs and symptoms in a late-stage study. The companies said they saw a statistically significant improvement in patient groups that received their drug, sarilumab, combined with methotrexate compared to those who just received methotrexate and a placebo.
Within the pharmaceutical industry, the rapid identification, elucidation and characterization of synthetic, process impurities and degradation products is an intense and comprehensive undertaking. In the development of a formulated drug substance, the U.S. Food and Drug Administration (FDA) requires that all impurities introduced in the proposed process above 0.1% must be isolated and fully characterized.
Drugmaker Eli Lilly and Co. plans to spend $715 million to bulk up its manufacturing in a key product line, insulin production. The Indianapolis company said it will spend $350 million to expand its insulin cartridge manufacturing in China, another $120 million for a similar improvement in France and $245 million to boost manufacturing capacity in Puerto Rico and Indianapolis.
The U.S. Food and Drug Administration has approved a new drug from Pharmacyclics and Janssen Biotech Inc. to treat a rare and aggressive form of blood cancer. The agency says it approved Imbruvica for patients with mantle cell lymphoma who have already received at least one previous drug therapy.
A team of scientists reports that a small-molecule compound showed significant success in controlling the infectivity and spread of three polyomaviruses in human cell cultures. To date there has been no medicine approved to treat such viruses, which prey on transplant recipients, people with HIV and others whose immune systems have been weakened.
A class of drugs used to treat parasitic infections such as malaria may also be useful in treating cancers and immune-related diseases, a new Washington State Univ.-led study has found. Researchers discovered that simple modifications to the drug furamidine have a major impact on its ability to affect specific human proteins involved in the on-off switches of certain genes.
GlaxoSmithKline says a potential heart disease treatment it acquired as part of a key 2012 company takeover fell short in the main measurement of a late-stage study. The British drugmaker says darapladib failed to produce a statistically significant reduction in major cardiovascular events like heart attacks, strokes or death when added to a patient's standard of care.
Arizona State University is teaming up with seven other research universities to establish a new Science and Technology Center (STC), sponsored by the National Science Foundation. The center will be based at the University at Buffalo. It is expected to transform the field of structural and dynamic molecular biology, including drug development, by using x-ray lasers to peer into biological molecules.
Merck said Monday that its new human papillomavirus vaccine was about 97% effective in blocking precancerous lesions caused by strains of the virus that are not stopped by Merck's vaccine Gardasil. Merck & Co. said it expects to file for marketing approval of the new vaccine, which is designated V503, before the end of 2013.
Researchers at Oregon State Univ. have discovered that one gene in a common fungus acts as a master regulator, and deleting it has opened access to a wealth of new compounds that have never before been studied—with the potential to identify new antibiotics.
Cisplatin is a chemotherapy drug given to more than half of all cancer patients. The drug kills cells very effectively by damaging nuclear DNA, but if tumors become resistant to cisplatin they often grow back. A new study offers a possible way to overcome that resistance. The researchers found that when cisplatin was delivered to cellular structures called mitochondria, DNA in this organelle was damaged, leading to cancer cell death.
Doctors may one day be able to control a patient's HIV infection in a new way: injecting swarms of germ-fighting antibodies, two new studies suggest. In monkeys, that strategy sharply reduced blood levels of a cousin of HIV. The results also gave tantalizing hints that someday the tactic might help destroy the AIDS virus in its hiding places in the body, something current drugs cannot do.
The U.S. Food and Drug Administration has approved a stronger, single-ingredient version hydrocodone, the widely abused prescription painkiller. The agency said it approved the extended-release pill Zohydro ER for patients with pain that requires "daily, around-the-clock, long-term treatment" that cannot be treated with other drugs.
The U.S. Food and Drug Administration has issued a positive review for a highly anticipated hepatitis C drug from Gilead Sciences, saying the pill cures more patients in less time than currently available treatments. The agency posted its review of Gilead's sofosbuvir online ahead of a meeting Friday where government experts will vote on whether to recommend the drug's approval.
Federal health advisers dealt a major blow to specialty drugmaker Amarin Corp., saying that the government should delay expanding approval of the company's prescription fish-oil drug until more patient data is available. The U.S. Food and Drug Administration's panel of outside advisers voted 9-2 against recommending broader use of Vascepa, a form of fish oil designed to lower triglycerides, a type of fat in the bloodstream.
Researchers at Oregon State Univ. and other institutions announced the successful use of a new type of antibacterial agent called a PPMO, which appears to function as well or better than an antibiotic, but may be more precise and also solve problems with antibiotic resistance. In animal studies, one form of PPMO showed significant control of two strains of Acinetobacter, a group of bacteria of global concern.
About a dozen years ago, scientists discovered that a hormone called ghrelin enhances appetite. Dubbed the “hunger hormone,” ghrelin was quickly targeted by drug companies seeking treatments for obesity—none of which have yet panned out. Neuroscientists have now discovered that ghrelin’s role goes far beyond controlling hunger.
Scotland announced that leading industry players, Sistemic and Roslin Cells, are going to work together with Scottish Development International to make the process of undertaking clinical trials in cell therapy easier, faster and more successful in reaching commercial realization.
Gilead Sciences said Wednesday it stopped a late-stage clinical trial of a cancer treatment because it was clear the drug was working. Gilead was studying idelalisib as a treatment for chronic lymphocytic leukemia. The company said an early analysis of data from the study showed that patients who were treated with idelalisib had a longer time before the resumption of disease progression or death.
Bayer HealthCare said Tuesday its drug Adempas has been approved as a treatment for two types of pulmonary hypertension, or high blood pressure in the arteries of the lungs. Bayer said it is already launching the drug, and called Adempas the first drug approved by the Food and Drug Administration as a treatment for more than one type of the disease.
Chemists at The Scripps Research Institute have devised a new technique for connecting drug molecules to antibodies to make advanced therapies. Antibody-drug conjugates are the basis of new therapies on the market that use the target-recognizing ability of antibodies to deliver drug payloads to specific cell types. The new technique allows drug developers to forge more stable conjugates than are possible with current methods.
A global hunt for genes that influence heart disease risk has uncovered 157 changes in human DNA that alter the levels of cholesterol and other blood fats—a discovery that could lead to new medications. Each of the changes points to genes that can modify levels of cholesterol and other blood fats and are potential drug targets.
Hold your nose and don't spit out your coffee: Doctors have found a way to put healthy people's poop into pills that can cure serious gut infections—a less yucky way to do "fecal transplants." Canadian researchers tried this on 27 patients and cured them all after strong antibiotics failed to help.
A biotech drug from Roche has become the first medicine approved to treat breast cancer before surgery, offering an earlier approach against one of the deadliest forms of the disease. The U.S. Food and Drug Administration (FDA) approved Perjeta for women with a form of early-stage breast cancer who face a high risk of having their cancer spread to other parts of the body.