Estradiol News and Research

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Estradiol is a sex hormone. Mislabelled the "female" hormone, it is also present in males; it represents the major estrogen in humans. Estradiol has not only a critical impact on reproductive and sexual functioning, but also affects other organs including the bones.

Bayer's oral contraceptives may increase risk of blood clots, stroke or heart attack

Bayer HealthCare Pharmaceuticals, Inc. is aware of two studies published today in The British Medical Journal, ONLINE FIRST.

25 Apr 2011

BioSante, Aduro BioTech enter license agreement for GVAX cancer vaccines

Aduro BioTech, a clinical-stage immunotherapy company, has licensed GVAX Pancreas Cancer Vaccine and GVAX Prostate Cancer Vaccine BioSante Pharmaceuticals, Inc. in exchange for milestone and royalty payments after commercialization.

19 Apr 2011

BioSante licenses Pancreas and Prostate cancer vaccines to Aduro BioTech

BioSante Pharmaceuticals, Inc. today announced it has licensed its Pancreas Cancer Vaccine and Prostate Cancer Vaccine to Aduro BioTech, a clinical-stage immunotherapy company, solely for use in combination with Aduro's proprietary vaccine platform based on Listeria monocytogenes (Lm).

19 Apr 2011

FDA accepts Teva's NDA filing of Bio-T-Gel for male hypogonadism

BioSante Pharmaceuticals, Inc. today announced that a New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd.. The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.

15 Apr 2011

A4M: Estrogen helps prevent risk of breast cancer in women

After timely breaking news this week about a study showing that estrogen lowers breast cancer risk in women, The American Academy of Anti-Aging Medicine could have almost started its 19th Annual Conference here today saying "I told you so."

11 Apr 2011

FDA accepts Antares Pharma's Anturol NDA for filing, assigns PDUFA date

Antares Pharma, Inc. today announced the New Drug Application (NDA) for Anturol® Gel in patients with overactive bladder (OAB) was accepted for filing for review by the U.S. Food and Drug Administration (FDA). Anturol is an oxybutynin gel incorporating Antares' ATD Gel technology.

8 Apr 2011

Merck's VICTRELIS phase III study results against HCV presented at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced results from several new data analyses from the pivotal Phase III studies evaluating the addition of its investigational oral protease inhibitor VICTRELIS to peginterferon alfa-2b and ribavirin in adult patients with chronic hepatitis C virus genotype 1 infection.

1 Apr 2011

BioSante completes patient enrollment in LibiGel Phase III trial against HSDD

BioSante Pharmaceuticals, Inc. today announced that enrollment of subjects in the second of two pivotal Phase III LibiGel safety and efficacy trials has been completed. Enrollment in the first LibiGel efficacy trial was completed in February.

30 Mar 2011

U.S. District Court rules in favor of Watson in generic SEASONIQUE patent infringement suit

Watson Pharmaceuticals, Inc., a leading integrated global pharmaceutical company, today confirmed that it has received a favorable decision from the U.S. Court of Appeals for the Federal Circuit related to its ongoing patent challenge in connection with Watson's Abbreviated New Drug Application seeking FDA approval to market a generic version of Teva Women's Health, Inc.'s SEASONIQUE and ethinyl estradiol.

28 Mar 2011

Study finds increased risk of VTE during first year of combination oral contraceptive usage

Bayer HealthCare Pharmaceuticals Inc. today announced that interim results from a large, prospective, observational cohort safety study offer insights into the increased risk of venous thromboembolism (VTE), or blood clots, which is a well-established risk in women who use combination oral contraceptives (COCs), also known as "the Pill".

25 Mar 2011

Graceway receives FDA approval for Zyclara Cream to treat genital warts

Graceway Pharmaceuticals announced today that the Food and Drug Administration has approved Zyclara Cream for the treatment of external genital and perianal warts in patients 12 years of age and older.

25 Mar 2011

PFC exposure can lead to early menopause in women

A recent study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism found that higher levels of perfluorocarbons in the body are associated with increased odds of having experienced menopause in women between 42 and 64 years old. Women in this age group with high levels of PFCs also had significantly lower concentrations of estrogen when compared to women who had low levels of PFCs.

24 Mar 2011

EMA CHMP adopts positive opinion for Teva's NOMAC-E2 contraceptive pill

Teva Pharmaceutical Industries Ltd. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for NOMAC-E2, an investigational contraceptive pill combining 1.5 mg of 17-beta-estradiol with 2.5 mg of nomegestrol acetate in a 24/4 monophasic regimen.

18 Mar 2011

Merck to present VICTRELIS phase III study data against HCV at EASL annual meeting

Merck, known as MSD outside of the United States and Canada, announced that several new data analyses from Phase III studies of VICTRELIS, its investigational oral hepatitis C protease inhibitor, will be presented at The International Liver CongressTM / 46th European Association for the Study of the Liver annual meeting.

9 Mar 2011

Mylan confirms lawsuit relating to Estradiol Transdermal System ANDA

Mylan Inc. today confirmed that the company has been sued by Vivelle Ventures LLC, Noven Pharmaceuticals Inc. and Novartis Pharmaceuticals Corporation in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Estradiol Transdermal System, USP (Twice-Weekly), 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day.

2 Mar 2011

Warner Chilcott fourth quarter revenue increases 1% to $694.4 million

Warner Chilcott plc today announced its results for the quarter and year ended December 31, 2010. As discussed more fully below, our financial position and results of operations in the quarter ended December 31, 2010 as compared to the prior year quarter were significantly impacted by several important transactions in 2009 and 2010.

25 Feb 2011

Noven claims patent infringement over Vivelle-Dot, files lawsuit against Mylan

Noven Pharmaceuticals, Inc. announced today that it has filed a lawsuit in the U.S. District Court for the Southern District of New York against Mylan Technologies Inc. ("Mylan") claiming infringement of certain Noven patents (the "Patents") by Mylan.

23 Feb 2011

FDA waives NDA filing fee for Antares' Anturol NDA

Antares Pharma, Inc. today announced the receipt from the U.S. Food and Drug Administration (FDA) of a waiver, on February 8, 2011, for the $1,500,000 New Drug Application (NDA) filing fee for Anturol® Gel for overactive bladder (OAB).

14 Feb 2011

TS Wiley develops HRT protocol using Idiom Decision Manager tool

The Wiley Protocol is a trademarked, patent protected bio-identical hormone replacement therapy delivery system consisting of biomimetic estradiol and progesterone in a topical cream preparation – dosed to mimic the natural hormones produced by a woman's body when she was in her prime. The Wiley Protocol is the brainchild of TS Wiley, a popular author and frequent speaker at medical seminars around the world.

7 Feb 2011

Merck reports GAAP net income of $861 million for 2010

Merck, known as MSD outside the United States and Canada, today announced financial results for the fourth quarter and full year of 2010. The company reported non-GAAP (generally accepted accounting principles) earnings per share (EPS) for the fourth quarter of $0.88, which excludes purchase accounting adjustments, restructuring costs and merger-related expenses.

4 Feb 2011