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Drug Headlines of 2011

Published on January 21, 2012 by Scott G. 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

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Drug Approvals Up for 2011

Published on January 20, 2012 by Scott G. 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

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

Published on January 20, 2012 by Scott G. 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

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Lights Out for Bayer’s YAZ?

Published on January 19, 2012 by Scott G. in FDA, Yaz

Posted January 6, 2012 by InjuryBoard Bayer AG, Germany’s largest drugmaker, blinked and swallowed hard, at the end of December, when it begged the Court overseeing the YAZ litigation. ayer managed to avoid the first trial which was set to start January 9th, over claims its birth-control pills caused blood clots after Judge Hearndon appointed a mediator in hopes of settling the cases. The plaintiffs were opposed to the setting of a mediator and wanted their day in court. Mediation Ordered U.S. District Judge David Herndon in Illinois postponed the January 9th trial of a lawsuit which alleged that Bayer mislead women about the health risks of its Yasmin family of birth-control pills. The case

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FDA Announces 10 Drugs With Severe Birth Defect Warnings

Published on January 19, 2012 by Scott G. in *Featured, Antidepressant, Birth Defects, Darvocet, FDA, Heart Risk, Paxil, Prozac, SSRI, Zoloft

Posted January 10, 2012 by SB Wire San Diego, CA — (SBWIRE) — 01/10/2012 – The drugs found on this list went through multiple tests, research experiments, and survey before the FDA classified them as dangerous to babies during pregnancy. Zoloft (sertraline), a popular antidepressant known as a “selective serotonin reuptake inhibitor” (SSRI), is linked to dangerous side effects in users and serious birth defects (including, heart murmur, hole in the heart and other serious heart defects) if taken by pregnant women. Since 2006, the FDA has warned against the use of Zoloft and other SSRIs in pregnant mothers. Paxil (paroxetine), one of the most widely prescribed SSRI’s for depression in adults has also been

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United States Joint Committee Wants Limit on the Use of Vaginal Mesh Products

Published on December 23, 2011 by Scott G. in FDA, Kugel & Transvaginal Mesh

Posted December 21, 2011 by EmailWire A Joint Committee issued by the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) recommends limiting the use of vaginal mesh to high-risk women only. (EMAILWIRE.COM, December 21, 2011 ) LegalView, a leading online legal resource, supports a Joint Committee Opinion issued by the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) which recommends limiting the use of trans vaginal mesh to high-risk women. Vaginal mesh is a surgical device implanted in women who have experienced a pelvic organ prolapse or suffer from incontinence, yet for most women, mesh complications may cause additional problems. High-risk women who receive the

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Dangerous Injuries Caused by Transvaginal Meshes and Other Pelvic Mesh Bladder Slings

Published on December 23, 2011 by Scott G. in FDA, Kugel & Transvaginal Mesh

Posted December 23, 2011 by InjuryBoard Sometimes as we age, our bodies don’t function like they once did. Women of any age can experience pelvic organ prolapse (POP) which causes pelvic organs to fall into the vaginal wall(s) causing discomfort, difficulty urinating and other problems. Specifically, women who have gone through a difficult delivery or have delivered a large baby may experience such a problem. Some time ago, various manufacturers developed a product to assist women experiencing this problem – a mesh to hold the pelvic organs in the proper place. The following is a list of such mesh products: Boston Scientific Uphold and Pinnacle Pelvic Floor Repair Kits, Gynecare (Ethicon) Prolift Anterior, Perigee and

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Vaginal Mesh Lawsuits Have Senate Seeking Increased Safety Measures

Published on December 23, 2011 by Scott G. in Kugel & Transvaginal Mesh

Posted December 21, 2011 by OpenPR (openPR) – Los Angeles, CA, December 20, 2011 – Nadrich & Cohen LLP reports that the U.S. Senate has proposed a new piece of legislation aimed at reducing the number of consumers who suffer serious injuries caused by a defective medical device. The bill, which would require manufacturers to conduct ongoing safety studies of these devices after obtaining FDA approval, was drafted in part as a response to the growing number of lawsuits filed against the makers of problematic vaginal mesh implants. Currently, the Food and Drug Administration allows certain medical devices to be approved under its 510(k) system. Based on these guidelines, manufacturers need only to demonstrate that

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FDA Issues Warning for Drug Alleged to Cause Elon Student’s Death

Published on November 21, 2011 by Scott G. in Yaz

Posted September 27, 2011 by Fox 8 ELON, N.C. (WGHP) — The FDA has issued a warning for a birth control drug alleged to have caused an Elon student’s death just over a year ago. Michelle A. Pfleger, a first-year student from Hackettstown, N.J., died Sept. 24, 2010, after collapsing while on her way to class. The Alamance County Medical Examiner determined Pfleger died of a blood clot, and a wrongful death lawsuit filed by Pfleger’s mother, Joan Cummins, alleges the clot was caused by Yaz and Yasmin. “I’m hoping that the FDA and its review will take some greater responsibility and really disclose the serious risk of these birth control pills,” Cummins said. Pfleger

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Proposed Avandia Settlement Would Pay U.S. $3B for Off-Label Marketing

Published on November 21, 2011 by Scott G. in Avandia, GSK

Posted November 7, 2011 by About Lawsuits GlaxoSmithKline and the federal government have reached a tentative $3 billion settlement over Avandia marketing charges, alleging that the company promoted the controversial and dangerous diabetes drug for uses that were not approved by the FDA or determined to be safe and effective. The Avandia settlement was announced on Thursday in a statement by Glaxo officials, who said they expect to finalize terms of the agreement next year, along with other cases that it defines as its most significant U.S. liabilities. If approved, the blockbuster settlement would be the largest ever for a drug company accused of illegal marketing. The U.S. Department of Justice (DOJ) has accused GlaxoSmithKline

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Posts Tagged ‘FDA’:

Drug Headlines of 2011

Drug Approvals Up for 2011

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

Lights Out for Bayer’s YAZ?

FDA Announces 10 Drugs With Severe Birth Defect Warnings

United States Joint Committee Wants Limit on the Use of Vaginal Mesh Products

Dangerous Injuries Caused by Transvaginal Meshes and Other Pelvic Mesh Bladder Slings

Vaginal Mesh Lawsuits Have Senate Seeking Increased Safety Measures

FDA Issues Warning for Drug Alleged to Cause Elon Student’s Death

Proposed Avandia Settlement Would Pay U.S. $3B for Off-Label Marketing

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