Government Agencies
FDA
CNBC's Meg Tirrell shares details of the FDA'a approval of Gilead's new immunotherapy drug to treat patients with non-Hodgkin lymphoma.
WASHINGTON/ COPENHAGEN, Oct 19- Denmark's Novo Nordisk will take aim at Eli Lilly in the growing diabetes market after an advisory panel to the U.S. Food and Drug Administration gave the green light to its semaglutide drug. Shares in Novo Nordisk rose almost 3 percent in early trading on Thursday, after the panel late on Wednesday concluded semaglutide is...
Oct 18- U.S. regulators approved on Wednesday a new therapy for a type of lymphoma, which was developed by Gilead Science Inc's Kite Pharma, marking the second approval for this potentially revolutionary approach to fighting cancer. The Food and Drug Administration approved the gene therapy, to be sold under the name Yescarta, to treat adults with large B-cell...
The Food and Drug Administration allowed sales of the treatment from Kite Pharma on Wednesday. It uses the same technology, called CAR-T, as the first gene therapy approved in the U.S. in August, a treatment for childhood leukemia from Novartis Pharmaceuticals. The treatment, called Yescarta, will cost $373,000 per patient, according to drugmaker Gilead...
Oct 18- A new cancer therapy for a type of lymphoma developed by Kite Pharma, which was recently acquired by Gilead Sciences Inc, won U.S. Food and Drug Administration approval on Wednesday, six weeks ahead of schedule. The drug, Yescarta, is the second in a new class of cancer treatments known as chimeric antigen receptor T-cell therapy, or CAR-T, which reprograms the...
WASHINGTON, Oct 18- Novo Nordisk A/S's new diabetes drug semaglutide is effective, reasonably safe and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The FDA typically follows the recommendations of its advisors. Analysts on average expect annual semaglutide sales to reach $3.17 billion by 2023, with...
WASHINGTON, Oct 18- Novo Nordisk A/S's new diabetes drug semaglutide is effective, reasonably safe and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The FDA typically follows the recommendations of its advisors. Analysts on average expect annual semaglutide sales to reach $3.17 billion by 2023, with...
Abbott forecast full-year adjusted 2017 profit from continuing operations of $2.48- $2.50 per share. It had earlier expected earnings per share of $2.43- $2.53. Several devices received U.S. Food and Drug Administration approvals in the quarter, including Abbott's FreeStyle Libre glucose monitoring system and two of its heart devices- HeartMate 3 and...
LONDON, Oct 18- U.S. regulators have granted a priority review to AstraZeneca's ovarian cancer drug Lynparza as a treatment for breast cancer, putting it on track for potential approval in the new disease area during the first quarter of 2018.. The successful breast cancer submission to the U.S. Food and Drug Administration follows a clinical study showing...
Oct 16- Regeneron Pharmaceuticals Inc and Sanofi SA said on Monday their drug to treat inflammation in the esophagus, mainly caused by food allergies, met the main goal of a mid-stage study. The U.S. Food and Drug Administration in late-March approved dupilumab to treat adults with moderate-to-severe eczema. The drug is marketed under the trade name Dupixent,...
Oct 16- Regeneron Pharmaceuticals Inc and Sanofi SA said on Monday their drug to treat infection in the esophagus, mainly caused by food allergies, met the main goal of a mid-stage study. The U.S. Food and Drug Administration in late-March approved dupilumab to treat adults with moderate-to-severe eczema. The drug is marketed under the trade name Dupixent, with a...
"We believe second-line hepatocellular carcinoma is a $1 billion global opportunity," Andy Hsieh from Wiliam Blair wrote in a note. The company, which has a market value of about $7.30 billion, plans to file for an expanded label with the U.S. Food and Drug Administration in the first quarter of 2018.. Hepatocellular carcinoma liver cancer is the third-leading...
Exelixis plans to file for an expanded label for the drug with the U.S. Food and Drug Administration in the first quarter of 2018.. Exelixis and France's Ipsen jointly announced a licensing agreement last year for the commercialization and further development of the drug outside the United States, Canada and Japan. Hepatocellular carcinoma liver cancer is...
CNBC's Meg Tirrell reports on Spark Therapeutics shares jumping after the FDA panel votes in favor of the company's gene therapy.
Oct 12- Spark Therapeutics Inc's experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded on Thursday, paving the way for the first U.S. gene therapy for an inherited disease. The FDA is not obliged to follow the recommendations of its advisers but typically does.
Oct 12- Spark Therapeutics Inc's experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded on Thursday, paving the way for the first U.S. gene therapy for an inherited disease. The FDA is not obliged to follow the recommendations of its advisers but typically does.
SILVER SPRING, Md.— The Latest on an FDA panel's discussion on a gene therapy treatment for blindness:. A panel of experts to the Food and Drug Administration voted unanimously in favor of Spark Therapeutics' injectable therapy, which aims to improve vision in patients with a rare mutation that gradually destroys normal vision. The FDA has until mid-January to...
Oct 12- Spark Therapeutics Inc's experimental gene therapy for a rare form of blindness improves vision and should be approved, advisers to the Food and Drug Administration concluded on Thursday, paving the way for the first U.S. gene therapy for an inherited disease. The panel voted unanimously in favor of the treatment, Luxturna, which is designed to treat...
*AcelRx says requests made by FDA "manageable". There were more than 33,000 deaths in the United States in 2015 related to the abuse of the family of heavy-duty painkillers, and the resulting outcry has made the FDA extremely cautious about issuing new approvals. The FDA last month rejected another opioid painkiller made by Intellipharmaceutics International...
*AcelRx says requests made by FDA "manageable". There were more than 33,000 deaths in the United States in 2015 related to the abuse of the family of heavy-duty painkillers, and the resulting outcry has made the FDA extremely cautious about issuing new approvals. The FDA last month rejected another opioid painkiller made by Intellipharmaceutics International...
