Pfizer Issues Statement On Voluntary Recall; Medivation and Astellas Announce Positive Results From the Phase 3 AFFIRM Trial Print E-mail
By Staff and Wire Reports   
Wednesday, 01 February 2012 19:45
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 1, 2012.

Pfizer Inc. (NYSE:PFE) issued the following statement regarding the voluntary recall of Lo/Ovral®-28 (norgestrel and ethinyl estradiol):  “We understand that this news can be very concerning and confusing for any woman who takes birth control pills to protect against unintended pregnancies.”  

“We have announced a voluntary recall of Lo/Ovral®-28 (norgestrel and ethinyl estradiol) and Norgestrel and Ethinyl Estradiol Tablets (generic) birth control pills in the United States.

“We understand that this news can be very concerning and confusing for any woman who takes birth control pills to protect against unintended pregnancies.

“We share your concerns and want to provide you with the most up-to-date and accurate information.

“Recently, it came to our attention that there may be an issue with the way some of these pills were packaged…and that the inactive or placebo pill may have been placed out-of-order in some packs.

“Upon discovery of the issue, we took corrective action and notified the FDA.

“Based on our own rigorous internal assessments of this problem, we believe there are approximately 30 packs of birth control pills that may have received an inexact count or inactive tablet.

“Because of our high quality standards, should we identify even one package that does not meet our high standards, we will voluntarily recall the entire lot.

“Therefore, we have voluntarily recalled the 28 lots - which is approximately 1 million packs - to ensure that any possibly impacted product is removed from pharmacy shelves - and women who use the product are alerted.


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Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. (Tokyo: 4503) announced positive results on all efficacy endpoints from the Phase 3 AFFIRM trial of the investigational drug MDV3100 in men with prostate cancer previously treated with chemotherapy. Data will be highlighted in a late-breaking oral presentation at the upcoming 2012 Genitourinary Cancers Symposium in San Francisco, CA on Thursday, February 2.

"MDV3100 outperformed our expectations in the AFFIRM trial by meeting the primary and secondary endpoints with strong statistical significance and demonstrating a favorable safety profile," said Howard I. Scher, M.D., chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center, and the co-principal investigator of the AFFIRM study. "These results, together with its convenient once-daily oral dosing regimen, should make MDV3100 a promising option for men with prostate cancer who have received prior hormones and chemotherapy."



Also Wednesday:



CONMED Corporation (NASDAQ: CNMD), a medical technology company specializing in medical devices for surgical and patient monitoring markets, announced today that the Company will participate in the 2012 Canaccord Genuity Musculoskeletal Conference, on Tuesday, February 7, 2012 at 9:00 AM Pacific time.

eHealth, Inc. (NASDAQ: EHTH), the leading online source of health insurance for individuals, families, and small businesses, announced today that the company plans to release fourth quarter and year-end 2011 financial results on February 16, 2012.

Eternity Healthcare Inc. (OTCBB:ETAH) (the "Company"), a medical device company, is pleased to announce today a major development in medical technologies. The Company introduces a new device for the injection of medicine into the body that does not require a needle.

Lightlake Therapeutics Inc. (OTCBB: LLTP) (the "Company" or "Lightlake"), an early stage biopharmaceutical company developing modern addiction treatments based on its expertise using opioid antagonists, announced today that there have been no material changes to its operations or its business affairs, and the Company is not aware of any undisclosed developments that would account for the recent unusual trading activity of its shares.

Rock Creek Pharmaceuticals, Inc., a subsidiary of Star Scientific, Inc. (NASDAQ: CIGX), today announced a new partnership with GNC, the global health and wellness retailer that specializes in premium, value-added nutritional products.

Syneron Medical Ltd. (NASDAQ: ELOS), the leading global aesthetic device company, today announced that it will release fourth quarter 2011 financial results before the market opens on Thursday, February 9, 2012.

Tibet Pharmaceuticals, Inc. (NASDAQ: TBET), an emerging specialty pharmaceutical company engaged in the development, manufacturing and marketing of traditional Tibetan medicine in China, today announced that it has signed a Letter of Intent ("LOI") to cooperate with Anhui Taihe Pharmaceutical Group Co., Ltd. ("Anhui Taihe Pharmaceutical Group"), a wholesale pharmaceutical distribution company based in Anhui province with a network across 16 provinces and municipalities in China.



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