Government Agencies FDA

  • Sept 29- Alcobra Ltd's market value more than halved on Thursday, a day after the company said the U.S. Food and Drug Administration had placed a hold on its lead experimental drug. Shares of the Israel- based company fell as much as 58 percent to a record low of $1.95. The disorder affects about 4.1 percent of American adults aged 18 and above in a given year, and 9...

  • WASHINGTON— Federal regulators have approved a first-of-a-kind "artificial pancreas," a device that can help some diabetes patients manage their disease by constantly monitoring their blood sugar and delivering insulin as needed. The device from Medtronic was approved Wednesday for patients with Type 1 diabetes, the kind usually diagnosed during...

  • The U.S. Food and Drug Administration, in its approval of the device, the MiniMed 670 G, hailed it as a breakthrough. Jeffrey Shuren, director of the FDA's medical device division, said in a statement. Analysts said the FDA approved the device six months sooner than expected.

  • Sept 28- Vertex Pharamceuticals Inc said the U.S. Food and Drug Administration expanded the use of its cystic fibrosis drug to treat a new subgroup of patients with the rare genetic disorder. The company said it now expects Orkambi revenue of $950 million to $990 million, down from $1.0 billion to $1.1 billion it had previously forecast. The FDA approved the use of...

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  • WASHINGTON— Federal regulators have approved a first-of-a-kind "artificial pancreas," a device that can help some diabetes patients manage their disease by constantly monitoring their blood sugar and delivering insulin as needed. The device from Medtronic was approved Wednesday for patients with Type 1 diabetes, the kind usually diagnosed during...

  • Sept 28- The U.S. Food and Drug Administration on Wednesday approved Medtronic Plc's "artificial pancreas" designed to automatically deliver the right dose of insulin to patients with type 1 diabetes. Jeffrey Shuren, director of the FDA's medical device division said in a statement. "This device will mean peace of mind, in knowing a person will be in normal blood...

  • *Expectations of peak sales of $2.3 bln seen cooling. The U.S. Food and Drug Administration has already approved Kyprolis for patients with relapsed or refractory multiple myeloma who have previously undergone treatment. Multiple myeloma, a type of aggressive and incurable blood cancer that develops in the bone marrow, kills about 12,600 people annually and...

  • The U.S. Food and Drug Administration has already approved Kyprolis for patients with relapsed or refractory multiple myeloma who have previously undergone one or more treatments. Kyprolis is the only approved therapy in the United States for relapsed multiple myeloma, and can be used as a single agent, doublet or triplet combination. It generated $172...

  • The U.S. Food and Drug Administration has already approved Kyprolis for patients with relapsed or refractory multiple myeloma who have previously undergone one or more treatments. Multiple myeloma, a type of aggressive and incurable blood cancer that develops in the bone marrow, kills 12,650 annually and will be diagnosed in an estimated 30,330 Americans...

  • Sept 26- Johnson& Johnson said on Monday that the U.S. Food and Drug Administration approved the company's blockbuster psoriasis drug, Stelara, for use in adults with Crohn's disease. The drug is approved in the United States to treat the skin condition scaly plaque psoriasis and a type of arthritis associated with psoriasis. These treatments include J&J's own...

  • Sept 26- Vela Diagnostics said its test for the Zika virus had received "emergency use authorization" from the U.S. Food and Drug Administration. The test, already approved in Europe, is validated for plasma, serum and urine samples, the Singapore- based company said on Monday. Zika, which was detected in Brazil, has spread to the Americas and is associated with...

  • Amjevita is the fourth biosimilar to be approved by the FDA and is expected to be sold at a discount to the original drug. Unlike generics, which are interchangeable with their branded counterparts, biosimilars approved by the FDA to date are not considered interchangeable and therefore are not called generic. The FDA has determined, however, that there is no...

  • The Food and Drug Administration cleared a near-copy of the drug, dubbed Amjevita, developed by Amgen Inc. Regulators approved the drug for more than a half-dozen conditions listed on the original drug's label, including severe psoriasis and Crohn's diseases. But currently only one biosimilar cleared by the FDA approval pathway is actually on the market in...

  • Amjevita is the fourth biosimilar to be approved by the FDA and is expected to be sold at a discount to the original drug. Unlike generics, which are interchangeable with their branded counterparts, biosimilars approved by the FDA to date are not considered interchangable and therefore are not called generic. The FDA has determined, however, that there is no...

  • LONDON, Sept 21- Patients who take medicines derived from blood plasma or urine are not at increased risk of catching Zika, even if the body fluids come from countries where the virus is prevalent, Europe's drugs regulator said on Wednesday. The European Medicines Agency, Europe's equivalent of the U.S. Food and Drug Administration, said its experts had assessed...

  • CHARLESTON, W.Va.— West Virginia Attorney General Patrick Morrisey has subpoenaed drug company Mylan N.V. in an investigation over drastic price hikes for its EpiPen. Mylan CEO Heather Bresch and a Food and Drug Administration official will testify before the U.S. House Oversight and Government Reform Committee on Wednesday. Joe Manchin of West Virginia.

  • Sept 19- Bowing to pressure from patient advocates, the U.S. Food and Drug Administration on Monday approved a treatment for Duchenne muscular dystrophy even though an outside panel of experts and the agency's own reviewers questioned the drug's efficacy. The FDA's lead reviewer, Dr. In an email to staff on Monday, Woodcock said the approval "reflects FDA's...

  • The drug was the first in the United States to be approved for the devastating disease and Sarepta's stock nearly doubled in value to $56.18 following the decision. Tim Lugo, an analyst with William Blair, estimates the drug will generate global peak annual sales of close to $2 billion. The FDA also granted Sarepta a rare pediatric disease voucher which...

  • The approval came despite an internal dispute among Food and Drug Administration officials that ultimately had to be resolved by the agency's chief. The FDA cleared Sarepta Therapeutics' Exondys 51 for a rare form of Duchenne muscular dystrophy, a deadly inherited disease that affects boys. It's the first FDA approval for the degenerative condition, which...