REUTERS: Aquestive Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its erectile dysfunction treatment and sought additional data.The company said the comments in the FDA's so-called complete response letter are "manageable" and that it would work with the agency for approval.The company's shares were down 6 percent in after-hours trading.Aquestive's Tadalafil oral film belongs to a class of drugs known as PDE5 inhibitors, the same class as Viagra and Eli Lilly's Cialis.The company informed the agency that it plans to engage an alternative supplier of the active pharmaceutical ingredient.About 20 million men in the United States suffer from erectile dysfunction and are treated with pills such as Viagra.Viagra has raked in blockbuster sales but is associated with side effects like headaches, blurred vision and dizziness."We continue to see a pathway to tentative approval before the expiry of the patents for the reference product," Aquestive … [Read more...] about FDA declines to approve Aquestive’s Viagra rival
Health
Novartis’ blood disorder drug gets FDA approval for expanded use
Health Novartis AG said on Friday the U.S. Food and Drug Administration expanded the use of its low platelets drug to treat patients with a rare, genetic blood disorder. 17 Nov 2018 07:15AM Bookmark REUTERS: Novartis AG said on Friday the U.S. Food and Drug Administration expanded the use of its low platelets drug to treat patients with a rare, genetic blood disorder.The drug, Promacta, received the green light as a combination with standard immunosuppressive therapy to treat patients two years and older suffering from treatment-resistant severe aplastic anemia (SAA).SAA is a blood disorder in which a patient's bone marrow fails to produce enough red blood cells, white blood cells and platelets."Severe aplastic anemia can be a fatal diagnosis if left untreated, and many patients fail to respond to current initial treatment options," Liz Barrett, chief executive of Novartis Oncology said in a statement.Promacta has been approved in more than 90 countries as a treatment for … [Read more...] about Novartis’ blood disorder drug gets FDA approval for expanded use
Make-a-Wish program tied to lower hospital costs for sick kids
(Reuters Health) - Kids with life-threatening illnesses who receive a special gift from the Make-a-Wish Foundation may have lower hospital costs than sick children who don't get these gifts, a U.S. study suggests.Make-a-Wish arranges experiences, or "wishes," for children with progressive, life-threatening, or life-limiting illness.Researchers compared unplanned hospital admissions and emergency room visits for 496 patients at Nationwide Children's Hospital in Columbus, Ohio and a control group of 496 kids with similar illnesses who didn't receive a wish.Compared to children who didn't receive a wish, children who did 2.5 times more likely to have a drop in unplanned hospital admissions in the year after the wish compared to the year before, and 1.9 times more likely to have a drop in emergency room visits from the year before to the year after, the study found.Overall, 62 percent of kids who received "wishes" had lower charges during the second year than during the first year, as did … [Read more...] about Make-a-Wish program tied to lower hospital costs for sick kids
Eleventh child dies from viral outbreak at New Jersey facility
REUTERS: An 11th child has died in less than four weeks at a New Jersey rehabilitation center, one of 34 young patients with compromised immune systems to have been infected by a viral outbreak, state health officials said on Friday.The child, who died late Thursday, and the others at the Wanaque Center for Nursing and Rehabilitation in the town of Haskell, became ill with adenovirus between Sept. 26 and Nov. 12, the state's Department of Health said in a statement.The deaths of the first six children at the facility's pediatric center were announced by health officials on Oct. 23.Adenoviruses frequently cause mild to severe illness with cold-like symptoms, particularly in young children. The infection can cause other illnesses, including pneumonia, diarrhea and bronchitis.The strain of adenovirus affecting the facility is associated with communal living arrangements, the health department said.State health officials, after prohibiting new admissions to the facility, said they put out … [Read more...] about Eleventh child dies from viral outbreak at New Jersey facility
Pfizer plans to increase US drug prices in January
Health Pfizer Inc said on Friday that it plans to hike U.S. prices on 41 of its medicines in January, after walking back its previous price increases this summer under pressure from President Donald Trump. 17 Nov 2018 04:35AM Bookmark NEW YORK: Pfizer Inc said on Friday that it plans to hike U.S. prices on 41 of its medicines in January, after walking back its previous price increases this summer under pressure from President Donald Trump.The company said in a statement that the increases would be on around 10 percent of its drugs. Pfizer said it would raise the price of most of the drugs by 5 percent, while prices for three will rise by 3 percent, and the price of one other will rise by 9 percent.(Reporting by Michael Erman; Editing by Leslie Adler) … [Read more...] about Pfizer plans to increase US drug prices in January