Pharmaceutical News: Bayer Responds to Studies Linking Birth Control Pills to Blood Clots

Bayer Responds to Studies Linking Birth Control Pills to Blood Clots

Following two studies that claim hormones used in newer birth control pills could put women at a greater risk of developing blood clots, Bayer HealthCare Pharmaceuticals, Inc. — who had three drugs put into question — has come out with its response.

In a statement released Thursday after the studies were published, the pharmaceutical company said it “re-affirms that the overall body of available scientific evidence continues to provide support that the risk of developing venous thromboembolism, or blood clots, in women using drospirenone-containing combination oral contraceptives is comparable to other combination birth control pills studied.”

The studies found that women who take drospirenone-containing pills, like Bayer’s Yazmine, Yaz and Ocella, had a two-to-three-fold increased risk of developing clots compared to levonorgestrel-containing pills.

Bayer contended “that the manner in which the authors applied the study methodology reported in these two publications and the databases used provide less reliable conclusions than are available from existing scientific evidence.”

The company also said the findings “do not change the overall assessment about the safety of Bayer’s oral contraceptives.”

Cumberland Pharmaceuticals to Announce First Quarter 2011 Financial Results on May 4, 2011

Cumberland Pharmaceuticals Inc.  announced today that it will release first quarter 2011 financial results after the market closes on Wednesday, May 4, 2011. A conference call and live Internet webcast will be held on Wednesday, May 4, 2011 at 5:00 p.m. Eastern Time to discuss the results.

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the acquisition, development and commercialization of branded prescription products. The Company’s primary target markets include hospital acute care and gastroenterology. Cumberland’s marketed products include Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States, and Kristalose® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products that improve quality of care for patients.

Idera delays hepatitis-C drug trials

Idera Pharmaceuticals Inc. has put the brakes on a Phase 2 trial of a treatment for a specific type of hepatitis C because early data showed certain types of cancerous growth in lab rats.

The trial was evaluating IMO-2125 plus ribavirin in treatment-naïve, genotype 1 hepatitis C virus (HCV) patients. Once Cambridge pharmaceutical Idera (Nasdaq: IDRA) evaluated toxicology studies involving rodents and non-human primates, researchers noticed that the rats showed instances of a condition called atypical lymphocytic proliferation.

While the date for a return to the Phase 2 studies wasn’t announced in today’s press release, Idera did say it was planning on having data from the primate toxicology studies in the second half of this year.

Idera CEO and chairman Sudhir Agrawal noted in the release that “IMO-2125 has been evaluated in 96 HCV-infected patients in two Phase 1 studies and no treatment-related serious adverse events or treatment-related discontinuations have been observed.” He also said the company would determine how to proceed with IMO-2125 after all toxicology data is in hand.

Just last week Idera touted good news, reporting that studies show its gene-silencing oligonnucleotides (GSOs) efficiently inhibited gene expression, overcoming issues associated with other gene-silencing technologies, such as stability, specificity and system delivery.

In October of 2010, Idera changed up its board following the retirement of James Wyngaarden. As a result, Agrawal took on the role of chairman of the board of directors and William Reardon was named lead director.

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