Government Agencies
FDA
Sept 22- The U.S. Food and Drug Administration has declined to approve Johnson& Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. The FDA's decision is in keeping with an advisory panel's recommendation in August that the FDA reject the drug.
The FDA's decision is in keeping with an advisory panel's recommendation in August that the FDA reject the drug. He added that the company is seeking to "gain a full understanding of FDA requirements for U.S. approval" and plans to have a follow-up discussion with the agency. In April the FDA declined to approve a rheumatoid arthritis drug made by Eli Lilly and Co...
Sept 22- The U.S. Food and Drug Administration has declined to approve Johnson& Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. The FDA's decision is in keeping with an advisory panel's recommendation in August that the FDA reject the drug.
The FDA warning comes two weeks after Intercept gave healthcare providers prescribing information for Ocaliva and flagged reports of liver failure and deaths. Nineteen deaths and 11 cases of serious liver injury were associated with the use of Ocaliva, the FDA said. "FDA's narrative about the high number of deaths and worsening of PBC cases strikes us as...
Sept 21- The U.S. Food and Drug Administration warned on Thursday that Intercept Pharmaceuticals Inc's drug Ocaliva was being incorrectly dosed in some patients with a rare liver disease, increasing the risk of liver injury and death. The U.S. drugmaker's shares fell 8.7 percent to $89.54 in afternoon trading. The FDA said some patients were receiving higher...
The FDA late Monday approved sales of Trelegy Ellipta, developed jointly by GlaxoSmithKline PLC and Innoviva Inc. It contains three widely used types of medicine to prevent— rather than treat— flare-ups of the life-threatening breathing disorders. U.K.- based GlaxoSmithKline is launching Trelegy with a list price of $530 per month. That's $146 a month cheaper...
After the outbreak, Congress in 2013 passed the Drug Quality and Security Act, which aimed to bring more compounding pharmacies, which make custom medications, under the authority of the FDA rather than state pharmacy boards. The law created a category of "outsourcing facilities" that could register with the FDA, allowing them to sell products in bulk to...
Sept 14- The U.S. Food and Drug Administration said on Thursday it has approved Bayer AG's treatment for follicular lymphoma, a cancer of the lymph system. An estimated 72,240 people in the United States will be diagnosed with some form of non-Hodgkin lymphoma this year. The FDA granted Aliqopa accelerated approval, meaning clinical data suggests it will be...
Sept 14- The U.S. Food and Drug Administration said on Thursday it has approved Amgen Inc's biosimilar version of Roche Holding AG's cancer drug Avastin. Amgen's drug, Mvasi, was approved for multiple types of cancer and is the first biosimilar approved in the U.S. to treat cancer. Biosimilars are somewhat cheaper copies of biologic drugs.
Sept 13- A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline's Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over. While the FDA is not required to follow recommendations of its advisory panels, the enthusiasm expressed would seem to indicate that approval...
Sept 13- A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline's Shingrix shingles vaccine warrants approval for its use in adults aged 50 and over. While the FDA is not required to follow the advice of its expert panels, it typically does so, with an approval decision expected in coming weeks.
Sept 13- A U.S. Food and Drug Administration advisory panel on Wednesday voted 11-0 that the safety and efficacy of GlaxoSmithKline's shingles vaccine warrants approval for its use in adults aged 50 and over. Panel members said Shingrix represents an improvement over Zostavax, the current marketed shingles prevention vaccine from Merck& Co..
Sept 12- Sage Therapeutics Inc said on Tuesday its drug to treat a life-threatening seizure disorder failed to meet the main goal of a late-stage trial, sending its shares down about 24 percent. SRSE accounts for about 25,000 to 41,000 cases each year in the United States and there are currently no treatments approved by the U.S. Food and Drug Administration for...
Sept 11- AbbVie Inc said on Monday two patients died in a late-stage trial testing its rheumatoid arthritis drug, raising safety concerns about the drug. In April, the U.S. Food and Drug Administration had declined to approve Eli Lilly and Co's rival drug, baricitinib, calling for an additional clinical study. Three months later, Lilly said the FDA was concerned...
PARIS, Sept 11- Sanofi and Regeneron's biotech drug dupilumab scored a hit in treating severe asthma, clinical trial data showed on Monday, raising competition in an expected multibillion-dollar market. Sanofi and Regeneron plan to submit an application to use the medicine in severe asthma to the U.S. Food and Drug Administration by the end of this year.
Sept 7- A U.S. regulator this week told Pfizer Incs Meridian Medical Technologies division, maker of the EpiPen injector device, that serious component and product failures have been associated with patient deaths and severe illness. In a Sept. 5 warning letter, the Food and Drug Administration said that the Pfizer unit failed to adequately investigate...
That stunning revelation is contained in a warning letter the FDA sent to the division of drug giant Pfizer, which makes EpiPens for Mylan.
It is also closing a plant in Iowa and research and development offices in New Jersey and China. Lilly expects charges of about $1.2 billion before tax, or $0.80 per share after tax. Lilly outlined in July a likely multi-year delay for its experimental rheumatoid arthritis drug baricitinib, after the U.S. Food and Drug Administration declined to approve the drug,...
Sept 7- AbbVie Inc said on Thursday its experimental drug to treat adults with moderate-to-severe eczema met the main goal in a mid-stage study, dragging down shares of rival U.S. biotech firm Regeneron Pharmaceuticals Inc.. Regeneron's eczema drug, Dupixent, was approved by the U.S. Food and Drug Administration in March. AbbVie's mid-stage trial data for its...
Sept 7- Celgene Corp said on Thursday the U.S. Food and Drug Administration had placed a partial clinical hold on five cancer trials and a full clinical hold on another trial that involved testing an existing drug in combination with other treatments. The decision by the FDA was based on risks identified in trials by Merck& Co on its drug Keytruda in combination...
