Feature Channels: Pharmaceuticals

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Eagle Pharmaceuticals, Inc. today announced the U. S. Food and Drug Administration (FDA) has approved Ryanodex® (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity.

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In lab experiments using tissue samples cultured from cystic fibrosis patients, scientists at the UNC School of Medicine and the UNC Marsico Lung Institute have shown that a new CF drug counteracts the intended beneficial molecular effect of another CF drug.

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COLA, the largest private accreditor of medical laboratories serving more than 8,000 across the U.S., successfully concluded its 2014 Leadership Summit in April. More than 30 thought leaders in health care, including physicians, regulators, public health experts, medical laboratory scientists, manufacturers, nurse practitioners and more gathered in San Francisco to discuss the future of laboratory medicine in the context of the Affordable Care Act (ACA). The group explored the implications of the dynamics of ACA and changing payment policies on quality and learning in laboratory medicine.

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The nation’s healthcare system -- and with it, the laboratory community – is undergoing a period of tremendous change as The Affordable Care Act begins implementation and new healthcare delivery models such as The Patient-Centered Medical Home (PCMH) and Accountable Care Organizations (ACOs) proliferate. With more than 70 percent of medical decisions based on lab data, laboratories are emerging as vital partners of these new healthcare teams. Labs are uniquely qualified to use the patient data they capture to provide feedback to allied health professionals that can increase efficiency and contain health-care costs while improving patient care.

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COLA Inc., based in Columbia, MD, an independent, nonprofit laboratory CLIA-accreditation organization, accrediting more than 7,000 clinical diagnostic labs on July, 2013, launched a new education subsidiary, COLA Resources Inc. (CRI®), whose mission is to “Provide educational & consultative services aimed at improving laboratory medicine and patient care.”

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Diazyme Laboratories today announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its Vitamin D assay for Clinical Chemistry Analyzers. In line with the rapid increasing clinical demands for testing of this important biomarker, Diazyme’s new Vitamin D assay, utilizing its femtoquantTM technology (a sensitive homogenous enzyme-immunoassay platform), provides the first fully automated Vitamin D test for use on general clinical chemistry analyzers. Diazyme’s Vitamin D assay measures total 25-hydroxy Vitamin D (sum of 25-(OH)D3 + 25-(OH)D2 ) levels.

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Chemclin’s Anti-TB assay provides components for in-vitro qualitative determination of Antibody to Mycobacterium Tuberculosis (Anti-TB) in human serum or plasma by an indirect chemiluminescent assay method.

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Chemclin’s new Vitamin D assay provides components for in-vitro quantitative determination of 25-Hydroxy Vitamin D (25-OH Vitamin D) in human serum by a competitive chemiluminescent assay method.

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Chemclin’s Anti-TP assay provides components for in-vitro qualitative determination of Antibody to Treponema Pallidum (Anti-TP) in human serum or plasma by a double - antigen sandwich chemiluminescent assay method.

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Chemclin’s HIV kits are available for in-vitro qualitative determination of Antibody to Human Immunodeficiency Virus Type 1 and Type 2 (Anti-HIV 1+2) and P24 antigen of HIV in human serum or plasma by a sandwich chemiluminescent assay method.

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Chemclin provides a wide range of chemiluminescent immunoassays for in-vitro diagnosis, covering infectious diseases, tumor markers, thyroid functions, fertility, diabetes, liver fibrosis and other panels. Most of them are CE certified and all of them are designed for both the semi-automated (Chemclin®100) and fully automated (Chemclin®600) chemiluminescent immunosystems in quantitative and qualitative determinations.

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Applied and effortless simplicity of Burkert products have always been something to rely on – now we have added pure flexibility to the list of standards you can expect. The unique Pneumatic Dosing unit from Burkert – ultra precision and repeatability of fluid dosing come together with a flexible, customizable design giving you precisely the results that matter to you. Whether your world is dosing pharma media or syrup, vaccines or coffee flavors, wide ranging performance just met your changing needs.

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Scientists at The Scripps Research Institute and Hong Kong University of Science and Technology and their collaborators have found that ancient enzymes, known for their fundamental role in translating genetic information into proteins, evolved myriad other functions in humans.

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Boni Elewski, M.D., led one of two trials featured in the New England Journal of Medicine that show secukinumab is a safe and effective psoriasis treatment.

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Heart disease and stroke are the leading causes of death and disability among people with Type 2 diabetes. In fact, at least 65 percent of people with diabetes die from some form of heart disease or stroke, according to the American Heart Association. However, a new study by researchers at Wake Forest Baptist Medical Center suggests that the use of cholesterol-lowering statins may help prolong the lives of people with diabetic cardiovascular disease.

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Pulmonary inflammation can cause shallow breathing and the lungs to become brittle in patients who experience multiple blood transfusions, sepsis, lung surgery and acute lung trauma. This complication can leave patients on ventilators, which can further traumatize the lungs, and often results in a mortality rate of 30 to 40 percent. To date, no medication has been successful at preventing or mitigating the damage caused by lung inflammation. Now, a multidisciplinary research team led by David Eckmann, MD, PhD, Horatio C. Wood Professor of Anesthesiology and Critical Care at the Perelman School of Medicine at the University of Pennsylvania and professor of Bioengineering in Penn’s School of Engineering and Applied Science, has found that when delivered by a microscopic transporter called a nanocarrier, steroids can access the hard-to-reach lung endothelial cells that need it most and are successful at preventing inflammation in mice.

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The drug letrozole results in higher birth rates in women with polycystic ovary syndrome (PCOS) than the current preferred infertility treatment drug, according to a nationwide study led by Penn State College of Medicine researchers.

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Researchers discover that enzyme involved in intracellular signaling plays a crucial role in developing metabolic syndrome, a finding that has a U of U spinoff company developing a drug to potentially treat the condition.

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The results of The Sanford Project’s first clinical trial are published in the July edition of The Lancet Diabetes & Endocrinology, revealing the outcome of a two-year study exploring the benefits of two drugs in treating type 1 diabetes.

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Every living cell’s surface has a protein-embedded membrane that’s covered in polysaccharide chains – a literal sugar coating. A new study by a Cornell University researcher found this coating is especially thick and pronounced on cancer cells – leading to a more lethal cancer.

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Researchers have spotted a strong family trait in two distant relatives: The channels that permit entry of sodium and calcium ions into cells share similar means for regulating ion intake. The new evidence is likely to aid development of drugs for channel-linked diseases ranging from epilepsy to heart ailments to muscle weakness.

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USDTL (United States Drug Testing Laboratory, Inc.) has succeeded in improving their umbilical cord screening assay for buprenorphine by reducing the positive result cutoff from 1.0 ng/g down to 0.5 ng/g. The improved umbilical cord buprenorphine assay gives the best possible detection of buprenorphine exposure, making it possible to identify more newborns exposed to buprenorphine in utero.

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Whitehead Institute scientists have genetically and enzymatically modified red blood cells to carry a range of valuable payloads—from drugs, to vaccines, to imaging agents—for delivery to specific sites throughout the body.

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St. John’s wort, the leading complementary and alternative treatment for depression in the United States, can be dangerous when taken with many commonly prescribed drugs, according to a study by researchers at Wake Forest Baptist Medical Center.

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Green-chemistry researchers at McGill University have discovered a way to use water as a solvent in one of the reactions most widely used to synthesize chemical products and pharmaceuticals.

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TheResearchers at The Children’s Hospital of Philadelphia’s PolicyLab found an increase in the concurrent prescribing of second-generation antipsychotics (SGA) – typically used to treat severe mental disorders – with other psychotropic medications among Medicaid-enrolled youth. From 2004-2008, the majority of Medicaid-enrolled youth using SGA were prescribed this medication concurrently with another psychotropic medication class. Researchers say the data is a rich resource for providing a picture of clinical practice trends on a national scale and can valuable in informing policies and practice around SGA use.

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The human monoclonal antibody known as m102.4, which has proven effective in protecting against the frequently fatal Hendra virus, has now been shown in studies to protect against the closely related Nipah virus -- the basis of the 2011 movie "Contagion" -- a highly infectious and deadly agent that results in acute respiratory distress syndrome and encephalitis, person-to-person transmission, and greater than 90 percent case fatality rates among humans. The results of the study, conducted by a team of Federal and university scientists, will appear in Science Translational Medicine online: “Therapeutic Treatment of Nipah Virus Infection in Nonhuman Primates with a Neutralizing Human Monoclonal Antibody." The full study will be available following the release of the embargo at 2 p.m. June 25, 2014.

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Mohamad Koubeissi, M.D., director of the Epilepsy Center and associate professor of neurology at the George Washington University School of Medicine and Health Sciences, is leading a clinical trial employing low-frequency deep brain stimulation to potentially help reduce epileptic seizures in patients with mesial temporal lobe epilepsy.

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Muscle wasting that occurs as a result of cancer negatively impacts the well-being and recovery prospects of millions of patients, particularly the rapidly-growing elderly populations in Western societies. Drugs called selective androgen receptor modulators (SARMs) offer hope for these patients, and a new SARM for transdermal administration is promising excellent efficacy without harming liver function and HDL levels. Results and conclusions were presented Tuesday at the joint meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago.

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Saint Louis University researchers describe two discoveries: a molecular pathway by which a painful chemotherapy side effect happens and a drug that may be able to stop it.

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Obese and overweight Americans who have tried losing weight report far greater overall satisfaction with weight loss surgery and prescription weight loss medications than with diet, exercise and other self-modification methods, an Internet survey finds. The results were presented Saturday at the joint meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago.

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An investigational drug to treat Type 2 diabetes, empagliflozin, lowers blood pressure in patients with Type 2 diabetes and hypertension (high blood pressure), a new study finds. The results were presented Sunday in a late-breaking abstract at the joint meeting of the International Society of Endocrinology and The Endocrine Society: ICE/ENDO 2014 in Chicago.

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Postmenopausal women with osteoporosis who take denosumab long-term have increased bone density, sustained low rate of fractures, and a favorable benefit/risk profile, a new multinational study finds. The results were presented Sunday, June 22, at ICE/ENDO 2014, the joint meeting of the International Society of Endocrinology and the Endocrine Society in Chicago.

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Adult offspring of mothers who used fluoxetine, a common antidepressant, during pregnancy were more likely to develop a fatty liver, a new animal study has found. The results will be reported Saturday at the joint meeting of the International Society of Endocrinology and the Endocrine Society: ICE/ENDO 2014 in Chicago.

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Researchers have demonstrated for the first time in an animal model that maternal use of a class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs, resulted in increased fat accumulation and inflammation in the liver of the adult offspring, raising new concerns about the long-term metabolic complications in children born to women who take SSRI antidepressants during pregnancy.

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Researchers at the University of Michigan have obtained the first three-dimensional snapshots of the "assembly line" within microorganisms that naturally produces antibiotics and other drugs.

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Bringing clarity to a decades-long debate, a national team of researchers led by experts from the Perelman School of Medicine at the University of Pennsylvania has found that adding clot-busting medications known as thrombolytics to conventional approaches when treating sudden-onset pulmonary embolism patients is associated with 47 percent fewer deaths than using standard intravenous or under-the-skin anticoagulant medications alone.

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Researchers at Duke Medicine have identified a new strategy for treating neuroblastoma using a modified version of heparin, a century-old injectable drug that thins the blood to prevent clots from forming. The study, conducted in mice and published June 17, 2014, in the Journal of Clinical Investigation, found that when heparin is altered to remove its blood-thinning properties, it can suppress and shrink neuroblastoma tumors without causing severe bleeding.

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In a further test of a novel theory that suggests autism is the consequence of abnormal cell communication, researchers at the University of California, San Diego School of Medicine report that an almost century-old drug approved for treating sleeping sickness also restores normal cellular signaling in a mouse model of autism, reversing symptoms of the neurological disorder in animals that were the human biological age equivalent of 30 years old.

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Adults over 65 who have recently begun thiazide diuretics are at a greater risk for developing metabolic-related adverse events, researchers at UT Southwestern Medical Center have found.

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Case Western Reserve University researchers have discovered that an existing drug, bortezomib (Velcade), has been shown to help prevent clot development. Lalitha Nayak, MD, an assistant professor of medicine, reports in the June 12 edition of the journal Blood, the anti-thrombotic effects of bortezomib are determined by KLF2.

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An international team of scientists, led by researchers at the University of California, San Diego School of Medicine, have identified the genes encoding a molecule that famously defines Group A Streptococcus (strep), a pathogenic bacterial species responsible for more than 700 million infections worldwide each year.

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A recently published clinical study in the Journal of the American Medical Association has answered an urgent question that long puzzled ER pediatricians: Is the drug lorazepam really safer and more effective than diazepam – the U.S. Food and Drug Administration-approved medication as first line therapy most often used by emergency room doctors to control major epileptic seizures in children?

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McMaster University researchers may have found a novel way to suppress the devastating side effect of statins, one of the worlds’ most widely used drugs to lower cholesterol and prevent heart disease. Their findings could lead to the next generation of statins by informing potential combination therapies while taking the drug.

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Results presented today at the 50th Annual Meeting of the American Society for Clinical Oncology (ASCO) and June 6 at the European Association of Palliative Care Research Conference show that stopping statins for cholesterol management in the late stages of cancer or other terminal illnesses may offer quality-of-life and even life-extending benefits.

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PHOENIX — June 2, 2014 — A promising new study from Mayo Clinic, in conjunction with Caris Life Sciences, points to immunotherapy as a possible treatment option for patients with the difficult-to-treat triple negative breast cancer mutation. The study was presented this week at the 50th annual meeting of the American Society of Clinical Oncology in Chicago.

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A study presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2014 reports the results of a first-in-human, phase 1 dose escalation trial of crizotinib (XALKORI) in 14 patients with advanced, MET-amplified non-small cell lung cancer (NCT00585195).

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If all eye doctors prescribed the less expensive of two drugs to treat two common eye diseases of older adults, taxpayer-funded Medicare plans could save $18 billion over a 10-year period, say researchers at the University of Michigan.

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CHICAGO — June 2, 2014 — In the largest clinical trial testing the effectiveness of one versus two drugs to treat HER2-positive breast cancer, lapatinib (Tykerb) did not add benefit to the standard trastuzumab (Herceptin) adjuvant therapy, researchers report at the 50th annual meeting of the American Society of Clinical Oncology (ASCO).

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Positive results from four clinical trials of investigational targeted drugs for advanced ovarian, lung, and thyroid cancers, and chronic lymphocytic leukemia were highlighted today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO). Findings from the mid- and late-stage trials suggest new ways to slow disease progression and improve survival for patients who experience relapses or resistance to available treatments.