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.

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

Antares initiates dosing in VIBEX MTX clinical study for rheumatoid arthritis

Antares Pharma, Inc. today announced that the first patient has been dosed in a clinical study evaluating the VIBEX™ MTX product which is being developed for the treatment of rheumatoid arthritis. The clinical study will evaluate several dose strengths of VIBEX MTX delivered with a proprietary autoinjector versus conventional needle and syringe administration by a healthcare professional.

2 Feb 2011

How estrogen decreases risk and delays onset and progression of Alzheimer's disease

An influential article in the journal Progress in Neurobiology provided one of the first comprehensive reviews of how estrogen potentially can protect against Alzheimer's disease and other neurological disorders.

27 Jan 2011

Researchers launch estrogen therapy trial to study depression, cardiovascular illness in women

Researchers at the University of North Carolina at Chapel Hill have launched a new clinical trial to determine if estrogen replacement therapy may help prevent depression and cardiovascular illness in women between the ages of 45 and 55.

13 Jan 2011

FDA accepts Merck's JANUMET extended-release formulation NDA for type 2 diabetes

Merck today announced that the New Drug Application (NDA) for the Company's investigational extended-release formulation of JANUMET for type 2 diabetes has been accepted for standard review by the U.S. Food and Drug Administration (FDA). The Company is also moving forward as planned with regulatory filings in countries outside the United States.

12 Jan 2011

Teva acquires Théramex

Teva Pharmaceutical Industries Ltd. announced today that it has completed the acquisition of Théramex, Merck KGaA's European-based women's health business.

5 Jan 2011

FDA approves Watson's novel oral contraceptive

Watson Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

22 Dec 2010

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Antares Pharma, today announced the filing of a New Drug Application with the U.S. Food and Drug Administration for Anturol Gel in patients with overactive bladder.

22 Dec 2010