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Alcon, the global leader in eye care and a division of Novartis, announces the launch of AcrySof IQ PanOptix Toric presbyopia- and astigmatism-correcting intraocular lens (IOL) for patients with pre-existing corneal astigmatism undergoing cataract surgery. It is a new option for astigmatic patients who seek to address their near, intermediate and distance vision needs with a single lens.
DePuy Synthes*, part of the Johnson & Johnson Family of Companies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the VIPER® and EXPEDIUM®Fenestrated Screw Systems. When used in conjunction with CONFIDENCETM High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors. The VIPER and EXPEDIUM Fenestrated Screw Systems may be used in open or percutaneous spinal fusion surgery.
The US Food and Drug Administration (FDA) granted six months of paediatric exclusivity for AstraZeneca's Symbicort (budesonide/formoterol) inhalation Aerosol.The FDA’s decision was based on the evaluation of trials conducted in children with asthma aged six up to 12 years in response to a Written Request (a prerequisite for qualifying for paediatric exclusivity under Section 505A of the Federal Food, Drug, and Cosmetic Act). Symbicort is currently approved in the US to treat asthma in patients 12 years and older and for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD) in adults.
Acetylcholine is a neurotransmitter in the brain that plays an important role in controlling attention and cognition. Acetylcholine system dysfunction is believed to be one of the causes of Alzheimer's disease (AD) and vascular dementia.
Patients with gastroesophageal reflux disease, known as GERD, who undergo laparoscopic anti-reflux operations compared with traditional open operations suffer fewer postoperative complications, experience faster recovery, and incur lower health care costs, according to study results published online as an article in press on the Journal of the American College of Surgeons website, ahead of print publication.
GERD affects nearly 20 percent of American adults, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Heartburn, a burning sensation in the chest, is a common symptom of GERD.
"Patients with GERD have an incompetent lower esophageal sphincter, which allows gastric acid to go back up into the esophagus," said lead study author Francisco Schlottmann, MD, a surgeon at the Center for Esophageal Diseases and Swallowing, University of North Carolina, Chapel Hill. "Anti-reflux surgery should be considered in patients who do not achieve complete control of their symptoms [regurgitation or cough] with medications; who do not want to take medications for the rest of their lives; or who experience complications of medical therapy."
For the study, researchers analyzed data in the National Inpatient Sample (NIS) database of more than 75,000 adults who underwent either laparoscopic or open fundoplication for GERD between 2000 and 2013. NIS represents 1,000 U.S. hospitals and contains data on more than seven million hospitalizations each year. During the study period, 58.4 percent of patients underwent laparoscopic procedures and 41.6 percent had open anti-reflux operations performed through a long abdominal incision.
The study showed that the rate of laparoscopic procedures increased from 24.8 percent in 2000 to 84.3 percent in 2013. "Surprisingly, in 2003, 12 years after the first laparoscopic anti-reflux operation was reported, only 25 percent of all the anti-reflux operations were performed laparoscopically in the U.S.," Dr. Schlottmann said. "Subsequently, the rate increased, but 15 percent of all anti-reflux operations were still being performed through an open approach in 2013. We believe this percentage is very high, and we hope that in the next year this percentage will decrease."
Along with discovering that the use of laparoscopy for the surgical treatment of GERD has increased significantly in the last decade, the researchers also found that, on average, the minimally invasive approach reduced length of hospital stay by approximately two days, and open operations were more than $9,000 more expensive than minimally invasive procedures.
The researchers also found that laparoscopic procedures were better for patients in terms of fewer complications. Laparoscopic anti-reflux operations were less likely to result in postoperative blood clots, wound complications, surgical site infection, esophageal perforation (which can be life threatening), bleeding, cardiac failure, and death.
"Our study highlights the fact that laparoscopic anti-reflux surgery is as effective as the open approach, and in 2017, with all its advantages, should be the standard of care," said senior study author Marco G. Patti, MD, FACS, a surgeon and Director of the Center for Esophageal Diseases and Swallowing, University of North Carolina, Chapel Hill.
"We found that laparoscopic surgery is associated with significantly lower costs. In addition, indirect costs of the open approach, including an impaired ability to work, time off from work, and intangible costs of postoperative pain and healing, are difficult to measure but also favor the laparoscopic approach," said Dr. Patti.
"GERD is a common digestive disorder that can usually be treated with dietary changes and medications such as proton pump inhibitors (PPIs). However, chronic and not-controlled GERD can cause serious complications. Repeated exposure to stomach acid can damage the lining of the esophagus and lead to a precancerous condition called Barrett's esophagus," said Dr. Schlottmann.
Study results also revealed that urban academic or teaching hospitals performed laparoscopic anti-reflux surgery at a higher rate than open procedures, 54.4 percent versus 45.6 percent. "We think that it is important to make this information more available to the public. In order to achieve good outcomes, anti-reflux surgery should be performed laparoscopically in specialized centers," said Dr. Patti.
A new study in rats shows that stem cell secretions, called exosomes, appear to protect cells in the retina, the light-sensitive tissue in the back of the eye. The findings, published in Stem Cells Translational Medicine, point to potential therapies for glaucoma, a leading cause of blindness in the United States. The study was conducted by researchers at the National Eye Institute (NEI), part of the National Institutes of Health.
Biocon Ltd, Asia's premier biopharmaceuticals company, announced today that the Ministry of Health (MoH), Malaysia, has awarded a three year contract, to its subsidiary, Biocon SDN. BHD., Malaysia, for supplying recombinant human insulin (rh-Insulin) formulations manufactured at its large scale biopharmaceutical facility in Johor, Malaysia. Biocon’s rh-Insulin is Malaysia’s first locally manufactured biosimilar biologic product approved by the National Pharmaceutical Regulatory Authority (NPRA), Malaysia, for commercial sales in the country.
Johnson & Johnson and Actelion Ltd, announced that they have entered into a definitive transaction agreement under which Johnson & Johnson will launch an all-cash tender offer in Switzerland to acquire all of the outstanding shares of Actelion for $280 per share, payable in U.S. dollars, which equates to CHF 280.08 per share as of January 25, 2017. The transaction, which was unanimously approved by the Boards of Directors of both companies, is expected to be immediately accretive to Johnson & Johnson adjusted earnings per share and accelerate Johnson & Johnson revenue and earnings growth rates. Johnson & Johnson will fund the transaction with cash held outside the United States.
Allergan's Rhofade cream is approved by the US Food and Drug Administration (FDA) for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical studies that evaluated the primary efficacy endpoint on day 29.
Roche's dedicated haematology testing solution, the cobas m 511 integrated haematology analyser, is now available for countries accepting the CE Mark. This launch marks the entry for Roche Diagnostics in the haematology market, with a Roche developed system.
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