Government Agencies FDA

  • Boehringer Ingelheim Pharmaceuticals shows bottles of Jardiance.

    The agency said Friday that it approved a new indication for a drug marketed by Eli Lilly and Boehringer Ingelheim.

  • Dec 2- The U. S Food and Drug Administration said on Friday it would allow Eli Lilly and Co to state that its diabetes drug Jardiance reduces the risk of death from heart problems, potentially boosting the drug's sales. Jardiance, also known as empagliflozin, was approved by the FDA in 2014 to help lower blood sugar in patients with type 2 diabetes.

  • Dec 2- The U. S Food and Drug Administration said on Friday it had approved Eli Lilly and Co and Boehringer Ingelheim Pharmaceuticals Inc's drug, Jardiance, to reduce the risk of cardiovascular death in patients with type 2 diabetes. The risk of death from heart disease is 70 percent higher in diabetics compared to those without diabetes, according to the U.S....

  • FDA: Eli Lilly drug reduces cardiovascular death

    Shares of Eli Lilly gains momentum on news of an FDA drug approval. CNBC's Seema Mody reports.

  • The White House said in a statement after the House vote: "The Senate should promptly pass this bill so that the President can sign it." The bill, sponsored by Republican Representative Fred Upton of Michigan, authorizes $4.8 billion to the National Institutes of Health and $500 million to the Food and Drug Administration to streamline the clinical trial process...

  • BILL PROVIDES $4.8 BILLION TO NATIONAL INSTITUTES OF HEALTH; $500 MILLION TO FOOD AND DRUG ADMINISTRATION.

  • Nov 30- Pfizer Inc said on Wednesday its experimental biosimilar of Roche Holding AG's blockbuster breast cancer treatment Herceptin was found comparable with the branded version in a key study. Unlike generic drugs, which are interchangeable with their branded counterparts, biosimilars approved by the U.S. Food and Drug Administration to date are not...

  • It provides new money for the National Institutes of Health and Food and Drug Administration, including funding for the White House's cancer moonshot and precision medicine initiatives. Fred Upton, R- Mich., who chairs the House Energy and Commerce Committee, announced details of the draft bill Saturday along with Sen. Lamar Alexander, R- Tenn., chair of the Senate...

  • WASHINGTON— Juno Therapeutics again halted its study of an experimental leukemia treatment Wednesday after two more patients died of complications. The Seattle company said that the latest deaths occurred earlier this week after patients suffered a severe form of brain swelling, similar to the previous two fatalities. The Food and Drug Administration...

  • The Seattle- based drug developer's shares sank as much as 35 percent to a record low of $19.40 in early trading on Wednesday. Juno said on Wednesday it had voluntarily put the mid-stage study on hold and informed the U.S. Food and Drug Administration earlier this week. The company is still evaluating the cause of the deaths and has not yet decided whether it will...

  • The company's shares tumbled nearly 45 percent to $15.90 in premarket trading on Wednesday. The company said on Wednesday it had voluntarily put the mid-stage study on hold and informed the U.S. Food and Drug Administration earlier this week. The FDA, which had imposed a hold on the trial after the deaths, lifted it after Juno reverted to its original drug regimen,...

  • The company's shares tumbled nearly 45 percent to $15.90 in premarket trading on Wednesday. The company said on Wednesday that it had voluntarily put the mid-stage study on hold earlier this week and also informed the U.S. Food and Drug Administration. The FDA had lifted its hold after Juno reverted to its original drug regimen, excluding fludarabine.

  • Revenue at Medtronic's diabetes unit rose 3 percent to $462 million in the second quarter ended Oct. 28. MiniMed 670 G- the first device that allows a glucose sensor to communicate with an insulin pump and automatically regulate insulin flow- was approved by the U.S. Food and Drug Administration in September and is expected to launch in spring 2017..

  • *Qtrly revenue $7.35 bln vs. est. Sales in its cardiac and vascular unit, where Medtronic sells defibrillators, pacemakers, heart valves and stents, were $2.58 billion in the second quarter ended Oct. 28, below analysts' average estimate of $2.64 billion, compiled by Evercore ISI. MiniMed 670 G was approved by the U.S. Food and Drug Administration in September and is...

  • Nov 22- Rivals Novo Nordisk and Sanofi have won U.S. approval for new combination drugs to treat diabetes, sparking a fresh battle for sales in a fiercely competitive market. Some 400 million people worldwide suffer from diabetes, with type 2 accounting for more than 90 percent of the total, as rising obesity rates fuel the epidemic in the United States and many...

  • Following the green light from the U.S. Food and Drug Administration, Sanofi said it planned to launch Soliqua in January 2017, while Novo intends to launch Xultophy in the first half of next year. Industry analysts expect Xultophy to generate annual sales of around $1.20 billion in 2021, while Soliqua is forecast to reach $550 million by then, according to...

  • Nov 21- Novo Nordisk A/S said the U.S. Food and Drug Administration approved on Monday its diabetes drug, Xultophy. The Danish drug maker said it planned to launch the drug in the United States in the first half of 2017.. Xultophy, approved in Europe since 2014, combines Novo's drug Tresiba, known also as insulin degludec, with its GLP-1 agonist Victoza, known also as...

  • Mylan has come under fire for raising the price of a pair of EpiPens to $600 from $100 in 2008 and listing it with Medicaid as a generic product even though it is listed with the U.S. Food and Drug Administration as a branded product. Companies pay smaller rebates to Medicaid for generics. Officials at the Justice Department and the Centers for Medicare and...

  • Nov 21- Intarcia Therapeutics Inc said on Monday it submitted a marketing application for its matchstick-size implantable drug-delivery pump for diabetes to the U.S. Food and Drug Administration. Privately held Intarcia, which clinched a royalty-based financing deal last year valuing the company at about $5.5 billion, is developing ITCA 650 in...

  • *Says will meet with FDA "as soon as possible". Dynavax Chief Executive Eddie Gray said on Monday the company would meet with the FDA "as soon as possible" to discuss concerns raised by the agency in a "complete response letter." The company said the FDA, in its letter, sought information about certain "adverse events" during clinical trials, among other clarifications.