Government Agencies FDA

  • File photo: a researcher in a Bristol-Myers Squibb laboratory.

    The lung cancer treatment is still expected to receive approval in the second half of 2018.

  • Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours. The pharmaceutical company cited "a review of data available at this time" for the decision to hold off on filing for Food and Drug Administration approval of the combination of its cancer drugs Opdivo and Yervoy. Merck said the FDA would decide by...

  • Jan 19- Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for its combination of two immunotherapy drugs as an initial treatment for lung cancer. Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours. Merck said the U.S. Food and Drug Administration would...

  • Jan 19- The U.S. Food and Drug Administration said on Thursday it had approved Synergy Pharmaceuticals Inc's drug to treat chronic idiopathic constipation. However, the safety and effectiveness of the drug have not been established in patients less than 18 years of age, the FDA said. The company's shares were marginally down at $6.40 in extended trading.

  • Jan 19- The U.S. Food and Drug Administration said on Thursday it had approved Synergy Pharmaceuticals Inc's drug to treat chronic idiopathic constipation. CIC is a type of gastrointestinal disorder where individuals have difficult and infrequent bowel movements. Synergy's plecanatide is expected to generate peak sales of $348.8 million by 2021,...

  • However, the FDA said it does not consider the supplementary information that is consistent with the FDA- required labeling guidelines alone to be evidence of a new intended use. If a firm communicates information, including on promotional material, that has not been evaluated by the regulator, but appears to be FDA- ratified, then it could lead to misbranding, and...

  • On Tuesday, British American Tobacco Plc announced a $49- billion deal to take over rival Reynolds American Inc, uniting two major e-cigarette players in the United States and United Kingdom and becoming a bigger competitor to Philip Morris International Inc and U.S. partner Altria Group. "Suddenly things that were not conceivable became something we...

  • If a firm communicates information, including on promotional material, that has not been evaluated by the regulator, but appears to be FDA- ratified, then it could lead to misbranding, and could subject firms to enforcement action if the representations or suggestions are considered false or misleading. To avert this, the FDA recommended on Wednesday that...

  • Jan 17- The U.S. Food and Drug Administration said it had approved the first generic version of Xyrem, Jazz Pharmaceuticals Plc's drug to treat patients with narcolepsy, a kind of sleeping disorder. The approved generic is developed by Roxane Laboratories Inc, the FDA told Reuters. About 70 percent people with narcolepsy suffer from cataplexy, the FDA said.

  • Jan 17- The U.S. Food and Drug Administration said on Tuesday it had approved the first generic version of Xyrem, Jazz Pharmaceuticals Plc's drug to treat patients with a medical condition that causes excessive daytime sleepiness.

  • Jan 17- Alcobra Ltd said it would abandon evaluating its only experimental drug to treat attention deficit hyperactivity disorder, after a failed late-stage study, wiping away more than half the company's value before the bell on Tuesday. Yaron Daniely said on a conference call. The U.S. Food and Drug Administration earlier this month recommended Alcobra...

  • Jan 17- Alcobra Ltd said on Tuesday its experimental attention deficit hyperactivity disorder therapy failed a late-stage study in adult patients and the company's shares plunged about 44 percent in premarket trading. The U.S. Food and Drug Administration earlier this month recommended that Alcobra conduct a new MDX trial to expel safety concerns...

  • Jan 17- Israeli drug developer Alcobra Ltd on Tuesday said its experimental drug to treat attention deficit hyperactivity disorder failed a late-stage study in adult patients. The announcement follows the recommendation of the U.S. Food and Drug Administration this month that the company conduct a new MDX trial to expel safety concerns emanating from...

  • Rep. Tom Price, R-Ga.

    Price and Rep. Chris Collins, R-N.Y., got a 12 percent discount in their private placement purchase of stock in an Australian drug company.

  • Jan 9- Canada's Valeant Pharmaceuticals International Inc said its affiliate will sell its Dendreon cancer business to China's Sanpower Group Co Ltd for $819.9 million, as the drugmaker continues to shed its non-core assets to repay debt. Dendreon makes prostate cancer vaccine Provenge that was approved by the U.S. Food and Drug Administration in 2010..

  • The Food and Drug Administration and the Department of Homeland Security said that St. The patch that Abbott began pushing out to patients on Monday addresses vulnerabilities that present the greatest risk to patients and prevent hackers from accessing the device, said FDA spokeswoman Angela Stark. "The FDA has maintained this focus on addressing patient...

  • Jan 9- The U.S. Food and Drug Administration on Monday approved Egalet Corp's long-acting opioid painkiller, Arymo ER, and will allow the company to claim it deters abuse by those seeking to dissolve and inject it. The FDA typically follows the advice of its advisory panels but is not obliged to do so. The FDA said in a statement that an extended-release morphine...

  • An employee walks near an Abbott Laboratories sign at the company's headquarters complex in Abbott Park, Illinois.

    The U.S. government had investigated claims the products were vulnerable to potentially life-threatening hacks.

  • Jan 9- The U.S. Food and Drug Administration said on Monday it has approved Egalet Corp's long-acting opioid painkiller, Arymo ER. The decision follows the recommendation of an independent panel of advisors to the FDA, which in August voted 18-1 in favor of approval. The FDA did not immediately say whether it has granted the abuse-deterrent label.

  • Jan 9- The U.S. Food and Drug Administration said on Monday it has approved Egalet Corp's long-acting opioid painkiller, Arymo ER. FDA in August voted 18-1 in favor of approval and recommended the drug be labeled as an abuse-deterrent product by the intravenous, nasal and oral routes of abuse. http://bit.ly/2jv97Ld. Lawmakers across the United States are...