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Understanding the mechanisms that mediate widespread DNA damage in the cancer genome is of great interest to cancer physicians and scientists because it may lead to improved treatments and diagnosis.
In this study, a multi-institutional team led by researchers at Baylor College of Medicine has brought attention to genomic structural variation as a previously unappreciated mechanism involved in altering DNA methylation, a form of gene control, in human cancers.
Sun Pharmaceutical Industries Ltd announced that one of its wholly-owned subsidiaries has commercialized CEQUA (cyclosporine ophthalmic solution) 0.09% in the U.S. CEQUA, which offers the highest concentration of cyclosporine for ophthalmic use approved by the U.S. Food and Drug Administration (FDA), is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory disease that afflicts more than 16 million people in the U.S.1 CEQUA is the first and only FDA-approved cyclosporine treatment delivered with nanomicellar (NCELL™) technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration.
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More than 1 billion people worldwide are living with vision impairment because they do not get the care they need for conditions like short and far sightedness, glaucoma and cataract, according to the first World report on vision issued by the World Health Organization.
U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the FDA has allowed to be marketed in the U.S. for the Ebola Virus Disease (EVD). The test provides a rapid, presumptive diagnosis that must be confirmed.
The Committee adopted by consensus a positive opinion for an initial marketing authorisation application for Neptra, from Bayer Animal Health GmbH, a new product for the treatment of canine otitis externa caused by susceptible strains of bacteria sensitive to florfenicol and fungi sensitive to terbinafine.
The U.S. Food and Drug Administration announced it has awarded two new research grants for natural history studies in rare diseases. The FDA is providing over USD 4.1 million over the next four years to fund these studies. Information from natural history studies can facilitate design of efficient clinical trials to test future treatments.
Natural history studies closely look at how specific diseases progress over time. The natural history of a disease is the course a disease takes from its onset, through the presymptomatic and clinical stages, to a final outcome in the absence of treatment.
The FDA received 31 grant applications that were reviewed and evaluated for scientific and technical merit by more than 45 rare disease, natural history, regulatory and statistical experts, that included representatives from academia, patient groups, the National Institutes of Health and the FDA. The grants were awarded to:
• University of Texas MD Anderson Cancer Center (Houston, Texas), Elizabeth Grubbs, prospective study in medullary thyroid carcinoma, approximately USD 1.7 million over four years
The study seeks to leverage a multi-institutional registry to characterize disease variables and patient perspectives that inform decisions regarding initiation of and adherence to chemotherapy in medullary thyroid cancer. Such critical knowledge can be incorporated into the design of clinical trials of emerging therapies for this disease.
• Vanderbilt University Medical Center (Nashville, Tennessee), Jonathan Soslow, prospective study in cardiac disease in Duchenne muscular dystrophy, approximately USD 2.4 million over four years.
This study aims to focus on cardiomyopathy (heart muscle disease), which is the leading cause of death in Duchenne muscular dystrophy. The study will combine genetic differences with imaging and blood biomarkers to identify surrogate biomarkers that predict the risk of cardiac dysfunction in Duchenne muscular dystrophy and other related diseases. This information has the potential to improve future clinical trial efficiency in these diseases by decreasing their size and cost.
Research topic preference accounts for more than 20% of a persistent funding gap for black scientists applying for National Institutes of Health research project (R01) grants compared to white scientists, according to a new study by NIH scientists. Researchers examined each step in the application submission and review process for R01 applications submitted between 2011-2015. The study confirms previous findings that career stage and institutional resources influence the gap in the number of submissions by black and white researchers. However, the finding that black applicants as a group are more likely to propose research topics that are less likely to be funded was new. The study published today in the journal Science Advances.
The U.S. Food and Drug Administration granted approval to Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria.
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New evidence from a WHO-led study, published in the Lancet, shows that more than one-third of women in four lower-income countries experienced mistreatment during childbirth in health facilities. Younger, less-educated women were found to be the most at risk of mistreatment, which can include physical and verbal abuse, stigmatization and discrimination, medical procedures conducted without their consent, use of force during procedures, and abandonment or neglect by health care workers.
The U.S. Food and Drug Administration announced that it has awarded 12 new clinical trial research grants totaling more than USD 15 million over the next four years to enhance the development of medical products for patients with rare diseases. The grants were awarded to principal investigators from academia and industry across the country.
The FDA awarded the grants through the Orphan Products Clinical Trials Grants Program, funded by Congress to encourage clinical development of drugs, biologics, medical devices and medical foods for the treatment of rare diseases. The grants are intended to substantially contribute to marketing approval of products to treat rare diseases or provide essential data needed for development of such products.
The FDA received 89 clinical trial grant applications that were reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts, including members of academia.
The grants awarded are focused on supporting product development to meet the needs of patients impacted by a variety of rare diseases, mainly those affecting children and cancers.
The recipients, principal investigators and approximate funding amounts, listed alphabetically, are:
• Chemocentryx, Inc. (Mountain View, California), Peter Staehr, phase 2 study of avacopan for the treatment of complement 3 glomerulopathy – USD 1 million over two years
• Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio), Maryam Fouladi, phase 1 study of PTC596 for the treatment of diffuse intrinsic pontine glioma & high-grade gliomas -- USD 750,000 over three years
• Cincinnati Children’s Hospital Medical Center (Cincinnati, Ohio), Parinda Mehta, phase 2 study of quercetin chemoprevention for the treatment of squamous cell carcinoma in patients with Fanconi Anemia – USD 1.7 million over four years
• Columbia University Health Sciences (New York, New York), Gary Brittenham, phase 2 study of daily vitamin D for the treatment of sickle-cell respiratory complications – USD 2 million over four years
• Cumberland Pharmaceuticals, Inc. (Nashville, Tennessee), Ines Macias-Perez, phase 2 study for oral ifetroban for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy – USD 1 million over three years
• Massachusetts General Hospital (Boston, Massachusetts), Sara Pai, phase 2 study of anti-PD1 therapy for the treatment of HPV-associated recurrent respiratory papillomatosis – USD 1 million over three years
• New York Medical College (Valhalla, New York), Mitchell Cairo, phase 2 study of viral specific cytotoxic T-lymphocytes for the treatment of refractory viral infections and T-cell immunodeficiency – USD 1.7 million over four years
• Privo Technologies, LLC. (Peabody, Massachusetts), Manijeh Goldberg, phase 1/2 study of cisplatin patch (PRV111) for the treatment of oral cancer – USD 2 million over four years
• Targeted Therapy Technologies, LLC (Somerset, New Jersey), Ricardo Carvalho, phase 1 study of episcleral topotecan for the treatment of retinoblastoma – USD 660,000 over three years
• University of Alabama at Birmingham (Birmingham, Alabama), Gregory Friedman, phase 1 study of oncolytic engineered herpes simplex virus therapy for the treatment of pediatric malignant cerebellar brain tumors – USD 750,000 over three years
• University of California San Diego (La Jolla, California), Jason Sicklick, phase 2 study of temozolomide for the treatment of gastrointestinal stromal tumor – USD 1.5 million over three years
• University of Texas MD Anderson Cancer Center (Houston, Texas), Michael Andreeff, phase 1/2 study of the imipridone (ONC201) for treatment of acute myeloid leukemia – USD 1 million over four years
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