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.
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 $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.
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.
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 $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.
Ensuring patient safety by improving medicine use and reducing medication errors is the crucial role of today’s pharmacists. “Safe and effective medicine for all”, the theme for this year’s world pharmacists day emphasises this crucial intervention and assistance of pharmacists sought by the healthcare delivery system. Achieving this noble objective of better patient health is next to impossible without the expert advice and assistance of pharmacists.