Drug News
TB Vaccine May Work Against Multiple Sclerosis
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A vaccine normally used to thwart the respiratory illness tuberculosis also might help prevent the development of multiple sclerosis, a disease of the central nervous system, a new study suggests.
In people who had a first episode of symptoms that indicated they might develop multiple sclerosis (MS), an injection of the tuberculosis vaccine lowered the odds of developing MS, Italian researchers report.
“It is possible that a safe, handy and cheap approach will be available immediately following the first [episode of symptoms suggesting MS],” said study lead author Dr. Giovanni Ristori, of the Center for Experimental Neurological Therapies at Sant’Andrea Hospital in Rome.
But, the study authors cautioned that much more research is needed before the tuberculosis vaccine could possibly be used against multiple sclerosis.
Early Heart Data Look Good for Obesity Drug
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Interim data from a cardiovascular safety study of an investigational weight-loss agent have met FDA criteria, and drugmaker Orexigen Therapeutics will seek to resubmit the drug for U.S. approval.
A company press release reported that the combination of naltrexone and bupropion (Contrave) didn’t double the risk of major adverse cardiovascular events (MACE) compared with placebo - a requirement set by the FDA - in an interim look at data from the Light Study, a cardiovascular outcomes trial.
The drug was denied FDA approval in February 2011, even though an advisory committee had voted largely in favor of approval. The agency required that the company conduct a cardiovascular outcome trial before it would approve the drug.
It also agreed that if the study could exclude a doubling of the risk of MACE with the drug compared with placebo, the company could submit the interim analysis for consideration in a resubmitted new drug application (NDA).
New technique for testing drugs to treat cystic fibrosis and epilepsy
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Researchers from the University of Southampton, in collaboration with researchers at the University of Quebec at Montreal, have developed a new microsystem for more efficient testing of pharmaceutical drugs to treat diseases such as cystic fibrosis, MG (myasthenia gravis) and epilepsy.
A large percentage of pharmaceutical drugs target ion channels, which are proteins found in a cell’s membrane, that play a pivotal role in these serious disorders and that are used to test the effectiveness of new drugs.
Ion channels create tiny openings in the membrane for specific ions (atoms that are positively or negatively charged) to pass through.
Currently researchers use electrophysiology, which measures an electric current through ion channel proteins, to evaluate the effectiveness of drugs on ion channels.
Cubist says urinary tract infection drug succeeds in study
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Cubist Pharmaceuticals Inc said its experimental treatment for a type of urinary tract infection showed it was as effective as an approved antibiotic.
The main goal of a late-stage trial was to show whether the treatment, a combination of ceftolozane and tazobactam, eradicated the infection and cured patients five to nine days after the last dose.
The most commonly reported adverse events of the treatment were headaches, constipation, hypertension, nausea and diarrhea.
Fungus-fighting drug may make mild flu meaner
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Mice given a drug commonly used in patients to fight systemic fungal infections more often succumb to what would otherwise be a mild case of the flu. The evidence reported in the Cell Press journal Cell Reports on November 21st shows that the drug called Amphotericin B, which has an estimated $330 million in sales around the world each year, can render a protein important for antiviral defense ineffective in both cells and mice.
The findings suggest that patients receiving the antifungal therapy may be functionally immunocompromised and more vulnerable to influenza and other viral infections, the researchers said.
“Many critically ill cancer and bone marrow transplant patients are treated with Amphotericin B-based therapies each year,” said Abraham Brass of the University of Massachusetts Medical School (UMMS). “Given these results in cells and mice, it may be worthwhile to consider that patients receiving, or who may receive, Amphotericin B-based therapies be appropriately vaccinated against influenza virus. Also, clinical consideration may be given to close monitoring of patients receiving Amphotericin B-based therapies for any symptoms suggestive of flu so that they might be considered for the early administration of an antiflu therapy.”
The researchers showed that Amphotericin-B prevents the antiviral protein in cells known as IFITM3 from fending off influenza A virus.
U.S. FDA panel backs BioMarin’s Morquio A Syndrome drug
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An experimental drug to treat Morquio A Syndrome, a rare genetic disorder that causes skeletal malformation and a variety of related lung, eye, ear and heart problems, should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday.
The 21-member panel voted overwhelmingly in favor of approval, saying the benefits of the drug, Vimizim, which is made by BioMarin Pharmaceutical Inc, outweigh its risks. The FDA is not obliged to follow the recommendations of its advisory panels but typically does so.
Morquio A Syndrome is characterized by a deficiency of an enzyme known as N-acetylgalactosamine-6-sulfatase, which causes excessive storage in the body of long chains of sugars known as glycosaminoglycans.
This build-up can lead to short stature and joint abnormalities that limit mobility and endurance. The disease can also cause hearing loss, eye problems and heart disease. Symptoms often appear before the age of five.
EU clears Roche drugs after probe into lax safety reports
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Europe’s main drugs regulator has found no new safety issues linked to Roche medicines after an investigation into the Swiss drugmaker, which was rapped last year for lax drug-safety reporting.
The European Medicines Agency (EMA) launched a probe into Roche in June 2012 after a routine inspection found it had failed to properly assess tens of thousands of cases of possible adverse drug reactions.
The investigation included 19 centrally approved drugs, several of which were for cancer. Roche is the world’s largest maker of cancer medicines, as well as producing drugs for viral infections and inflammatory diseases.
Drug shows early promise in treating seizures
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A study out today in the journal Nature Medicine suggests a potential new treatment for the seizures that often plague children with genetic metabolic disorders and individuals undergoing liver failure. The discovery hinges on a new understanding of the complex molecular chain reaction that occurs when the brain is exposed to too much ammonia.
The study shows that elevated levels of ammonia in the blood overwhelm the brain’s defenses, ultimately causing nerve cells to become overexcited. The researchers have also discovered that bumetanide – a diuretic drug used to treat high blood pressure - can restore normal electrical activity in the brains of mice with the condition and prevent seizures.
“Ammonia is a ubiquitous waste product of regular protein metabolism, but it can accumulate in toxic levels in individuals with metabolic disorders,” said Maiken Nedergaard, M.D., D.M.Sc., co-director of the University of Rochester Medical Center (URMC) Center for Translational Neuromedicine and lead author of the article. “It appears that the key to preventing the debilitating neurological effects of ammonia toxicity is to correct a molecular malfunction which causes nerve cells in the brain to become chemically unbalanced.”
In healthy people, ammonia is processed in the liver, converted to urea, and expelled from the body in urine. Because it is a gas, ammonia can slip through the blood-brain-barrier and make its way into brain tissue. Under normal circumstances, the brain’s housekeeping cells - called astrocytes - sweep up this unwanted ammonia and convert it into a compound called glutamine which can be more easily expelled from the brain.
Experimental drug shrinks cancer tumors
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An experimental cancer drug successfully shrank tumors in patients with different kinds of cancer, including typically hard-to-treat lung cancers, according to a new study. Oncologists said the research was encouraging, but more study was needed to know whether the drug would prolong life for cancer patients.
The study, led by Dr. Suzanne Topalian, was presented Friday at the Super Bowl of cancer professionals, a meeting of the American Society of Clinical Oncology, and published in the New England Journal of Medicine.
In a small, early phase study, researchers used a drug targeting a portion of the body’s immune system, a pathway called PD-1, which usually works to stop the body from fighting cancerous tumors. By shutting down the pathway, the drug stokes the body’s immune system to fight tumor cells.
Avastin Slows Resistant Ovarian Cancer
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Progression of platinum-resistant ovarian cancer slowed by more than 50% in patients who received bevacizumab (Avastin) plus chemotherapy compared with nonplatinum chemotherapy alone, results of a randomized trial showed.
Median progression-free survival (PFS) increased from 3.4 months with chemotherapy to 6.7 months with chemotherapy and bevacizumab.
The objective response rate more than doubled with the addition of the angiogenesis inhibitor, Eric Pujade-Lauraine, MD, of Hopital Hotel-Dieu in Paris, reported here at the American Society for Clinical Oncology meeting.
Prevnar trial results needed for CDC recommendation
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Advisors to the U.S. Centers for Disease Control and Prevention on Wednesday will wait for results from a trial of Pfizer Inc’s Prevnar 13 pneumonia vaccine before deciding whether to recommend its use in all adults aged 50 and older.
The trial results, expected next year, along with data on whether use of the vaccine in children is affecting rates of disease in adults, will be assessed before a recommendation is made, said CDC spokeswoman Alison Patti.
The Food and Drug Administration in December approved use of Prevnar 13 in older adults and Pfizer said it still expects to begin a marketing campaign in March.
Scientists Discover New Approach For Cancer Medication
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As the “recycling plant” of the cell, the proteasome regulates vitally important functions. When it is inhibited, the cell chokes on its own waste. Cancer cells, in particular, are very sensitive because they need the proteasome for their uncontrolled growth. Biochemists at the Technische Universitaet Muenchen (TUM) have now identified the lead structure of a new class of drugs that attacks the proteasome in an unusual way. New medication could be developed on the basis of this previously unknown binding mechanism. The scientists report their results in the scientific journal Angewandte Chemie.
The proteasome, a large protein complex, carries out a vitally important function in the cells of the body. Similar to a recycling plant, it decomposes unneeded proteins into short pieces and recycles them. In this way it controls a number of functions in the cell. It regulates cell growth and division, decomposes damaged proteins and also acts as a key partner of the immune system in immune defense and inflammatory reactions. Because it is involved in so many important mechanisms within the cell, the proteasome is also associated with many diseases such as cancer, mucoviscidosis and a whole series of neurodegenerative disorders such as Parkinson’s or Alzheimer’s disease.
Due to its significant role in the growth of cancer cells, in recent years the proteasome has taken center stage in pharmacological research as a starting point for cancer medication. When it becomes inhibited, the growth of cancer cells slows down. Bortezomib, the first drug to apply this strategy, generates revenues of over one billion US dollars per year in the meantime. It is used against multiple myeloma, a cancer disease of the bone marrow. Yet in spite of all its successes, the proteasome inhibitors currently in use often have severe disadvantages. As a result of their high reactivity they attack other proteins, too, thereby damaging not only cancer cells but also other healthy cells.
F.T.C. Criticizes Agreements That Delay Generic Drugs
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Some drug makers are using an indirect method to delay competition from low-cost generic products by promising not to introduce their own generic versions if a potential competitor delays its entry into the market, the Federal Trade Commission said in a report on Wednesday.
Until lately, the so-called pay-for-delay cases have focused mostly on cash payments by drug companies to settle patent litigation with generic competitors in return for concessions on when to enter the market. These new agreements add a twist to the patent settlements.
The industry contends they are legal business decisions.
Vaccine alliance seeks $3.7 bln from London meeting
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International health alliance GAVI is seeking $3.7 billion from a June 13 pledging conference in London to help deliver vaccines to nearly a quarter of a billion children across the world by 2015.
Launched in 2000 and including partners such as the World Bank and pharmaceutical firms, the grouping targets common but deadly diseases such as pneumonia or diarrhea and says it has already saved 5 million lives.
The alliance uses so-called “vaccine bonds” underpinned by firm market expectations that donors will ultimately honor their pledges to bridge the time lags in the funding process that are common to the aid sector.
Do painkillers interfere with antidepressants?
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Certain types of antidepressants may not work as well in people that take painkillers such as ibuprofen and aspirin, suggests a new study.
The findings can’t prove that the painkillers, called non-steroidal anti-inflammatory drugs, or NSAIDs, stop antidepressants from working, the authors said. But the possible link is something for patients with depression - and the doctors treating them - to think about when treating pain and inflammation, researchers report in Proceedings of the National Academy of Sciences, or PNAS.
“This is certainly something that clinicians and individuals should be keeping in mind,” Jennifer Warner-Schmidt, the study’s lead author from The Rockefeller University in New York City, told Reuters Health.
