Posts Tagged ‘patients’:


formats

Drug Headlines of 2011

Published on January 21, 2012 by in *Featured, FDA, General Drug News & Safety

Posted December 20, 2011 by The Scientist A list of this year’s newsworthy successes—and failures—in drug development Developing new medicines is tricky business, requiring sound science, regulatory savvy, and marketing skills. The past year has seen success and failure in all these realms. Here, The Scientist recounts some of the noteworthy drug developments of 2011. Notable Drug Approvals: First new lupus drug in 52 years After more than 18 years of development, the US Food and Drug Administration (FDA) approved the first drug to treat lupus in more than a half-century. Benlysta (belimumab) is a human monoclonal antibody, produced by Human Genome Sciences and GlaxoSmithKline, that cuts B-cells proliferation, a proposed mechanism underlying the autoimmune

[Continue Reading]

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off  comments 
formats

Drug Approvals Up for 2011

Published on January 20, 2012 by in FDA, General Drug News & Safety

Posted January 9, 2012 by The Scientist The FDA approved 30 drugs last year, the highest number in the last 7 years. The US Food and Drug Administration approved 30 drugs in 2011, compared with 21 in 2010, according to an analysis by Bloomberg News. That number is the highest since 36 drugs were approved in 2004. Some of the headline drugs to get the green light include Yervoy, a drug that primes the immune system to attack melanoma; Xarelto, which reduces clotting for patients with irregular heartbeats; and Benlysta, the first lupus drug approved in 50 years. The FDA toughened its data requirements in 2007, after critics faulted its response to claims of heart

[Continue Reading]

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off  comments 
formats

Faulty implants, dodgy drugs and a toothless watchdog that’s failing patients

Published on January 20, 2012 by in General Drug News & Safety

Posted January 10, 2012 by MailOnline Just over two years ago consultant plastic surgeon Azhar Aslam became deeply worried — he’d had to remove eight silicone breast implants from women within a few months of each other because they had ruptured prematurely. It struck him as highly unusual. ‘If implants do rupture, it is normally after seven to ten years, and it is usually caused by an impact, such as the wearer falling over or having a car accident,’ he says. But these implants had failed after only two to three years, and the patients had not been involved in any impact.’ All the implants were made by the French firm Poly Implant Prothese (PIP).

[Continue Reading]

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off  comments 
formats

J&J, C.R. Bard Must Study Safety of Vaginal Mesh, FDA Says

Published on January 20, 2012 by in *Featured, FDA, Kugel & Transvaginal Mesh

Posted January 5, 2012 by Bloomberg Johnson & Johnson (JNJ) and C.R. Bard Inc. (BCR) must study rates of organ damage and complications linked to vaginal mesh implants, U.S. regulators said, responding to patient advocates who say the devices have harmed women. The Food and Drug Administration wrote J&J, C.R. Bard and 31 other manufacturers, telling them to conduct three years of trials on safety and effectiveness, the agency’s William Maisel said yesterday in a telephone interview. An FDA report in July found a fivefold jump in deaths, injuries or malfunctions tied to the products. Almost 300,000 synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles, the

[Continue Reading]

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off  comments 
formats

Parents sue Pfizer over birth defects allegedly caused by Zoloft

Published on January 19, 2012 by in Birth Defects, Zoloft

Posted January 5, 2010 by Madison Record A group of parents who claim their children suffered severe birth defects because of Zoloft has filed a lawsuit against the drug’s manufacturer. Mary and David Saville, Terry and Todd Cochran, Anita Kinslow, Wendell Houchens, Erica Woodley and Antwynette Golliday joined a lawsuit filed Dec. 2 in St. Clair County Circuit Court against Pfizer Inc. Pfizer is the manufacturer of Zoloft, the antidepressant medication at the center of the suit. According to the nine-count complaint, the female plaintiffs were all prescribed Zoloft during their pregnancies, despite the alleged risks posed to their unborn children. The mothers claim their babies were all born with major medical defects, including heart

[Continue Reading]

 
 Share on Facebook Share on Twitter Share on Reddit Share on LinkedIn
Comments Off  comments