Urology News and Research

Latest Urology News and Research

Watson, Natco confirm development agreement for generic Revlimid

Watson Pharmaceuticals, Inc. and Natco Pharma Limited today confirmed an exclusive, U.S. development and license agreement, to develop and commercialize lenalidomide 5, 10, 15 and 25 mg tablets. The companies also confirmed that Natco has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its lenalidomide 5, 10, 15 and 25 mg product. Natco's lenalidomide tablets are generic versions of Celgene's Revlimid ® Tablets.

7 Dec 2010

Positive results from PROCHIEVE 8% vaginal progesterone gel Phase III trial to reduce preterm birth risk

Columbia Laboratories, Inc. and Watson Pharmaceuticals, Inc. today announced positive top-line results from the PREGNANT Study, a large, global Phase III clinical trial evaluating PROCHIEVE® 8% vaginal progesterone gel to reduce the risk of preterm birth in women with a short cervical length as measured by transvaginal ultrasound at mid-pregnancy.

7 Dec 2010

Wide-scale study of flu vaccine's effectiveness in European children needed

A wide-scale study of the effectiveness of flu vaccine in children is needed in Europe to fully assess the benefits, not only in keeping the kids from getting sick, but limiting the spread of flu to adults.

4 Dec 2010

FDA Advisory Committee votes in favor of expanded use of LAP-BAND gastric band

Allergan, Inc. (NYSE: AGN) today announced the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee has recommended with an 8-2 vote that the FDA extend the currently approved use of the LAP-BAND® System, Allergan's gastric band, on the basis of a favorable benefit-risk profile for weight reduction in obese adults who have failed more conservative weight reduction alternatives and have a Body Mass Index (BMI) of at least 35 or a BMI ≥30 and at least one comorbid condition.

4 Dec 2010

FDA Advisory Panel recommends approval of Solesta for bowel incontinence

Oceana Therapeutics, a global company focused on acquiring, developing and commercializing best-in-class specialty therapeutics, today announced that the U.S. Food and Drug Administration's (FDA) Gastroenterology and Urology Devices Panel recommended approval of Solesta™ as a treatment for fecal (bowel) incontinence, a condition afflicting many Americans, primarily women.

3 Dec 2010

UC Irvine receives Silver Medal from HHS for supporting organ, tissue donation

UC Irvine Medical Center recently received a Silver Medal of Honor from the U.S. Department of Health & Human Services for its role in supporting organ and tissue donation.

3 Dec 2010

New robotic arm device for early to mid-stage osteoarthritis

A robotic arm device developed to assist orthopedic surgeons with performing partial knee replacement surgery for early to mid-stage osteoarthritis is now available at NewYork-Presbyterian Hospital/Columbia University Medical Center. The technology was approved by the FDA in 2005, and to date nearly 5,000 cases have been performed in the U.S.

3 Dec 2010

Endo acquires Qualitest Pharmaceuticals

Endo Pharmaceuticals (Nasdaq: ENDP) announced today the completion of its acquisition of Qualitest Pharmaceuticals. Endo announced Sept. 28 that it entered into a definitive agreement to acquire Qualitest Pharmaceuticals, a leading, privately held generics company in the U.S., for approximately $1.2 billion in cash.

2 Dec 2010

Medivation, Astellas enroll 1,199 patients in MDV3100 Phase 3 AFFIRM study in advanced prostate cancer

Medivation, Inc. and Astellas Pharma Inc. today announced that patient enrollment was completed on November 15, 2010 in the Phase 3 AFFIRM study of the investigational drug MDV3100, a novel, triple-acting oral androgen receptor antagonist, in patients with advanced prostate cancer who have previously been treated with chemotherapy. The companies also announced that clinical development of MDV3100 in Japan has commenced, with the initiation of patient dosing in a Phase 1-2 clinical study.

30 Nov 2010

Perrigo launches generic Aleve Liquid Gels

Perrigo today announced that it has launched Naproxen Sodium Soft Gels. The product is the generic equivalent of Bayer HealthCare's Aleve® Liquid Gels, 220mg, an OTC analgesic. Aleve® Liquid Gels had sales of approximately $80 million, as measured by Information Resources, Inc. Perrigo believes it is the first to market a store brand version of this product.

29 Nov 2010

Texas Breast Specialists expands breast cancer treatment services

Texas Breast Specialists, part of Texas Oncology, has expanded its breast cancer treatment services in Dallas, McKinney, Bedford, Carrollton, and Plano, Texas to include the mobile Naviscan PEM scanner.

29 Nov 2010

Bref Rhone-Alpes honors EDAP with Best 2010 Product Innovation award for Sonolith i-move lithotripter

EDAP TMS SA, the global leader in therapeutic ultrasound, reported today that its new lithotripter Sonolith i-move received the Best 2010 Product Innovation award by the French economic journal Bref Rhone-Alpes. The award was presented on November 22, 2010 at a gathering of all major local economic and financial partners.

24 Nov 2010

Doctors provide tips to protect children from seasonal flu

Doctors at Cincinnati Children's Hospital Medical Center want to make sure children are protected from influenza this flu season. The flu is an infection of the nose, throat and lungs caused by a variety of strains of influenza viruses. While the flu typically causes mild symptoms, it can be severe enough to cause hospitalization or even death. Flu most commonly occurs in the winter and early spring.

20 Nov 2010

Researchers develop medical model for regenerating bladders using stem cells

Researchers in the United States have developed a medical model for regenerating bladders using stem cells harvested from a patient's own bone marrow. The research, published in STEM CELLS, is especially relevant for paediatric patients suffering from abnormally developed bladders, but also represents another step towards new organ replacement therapies.

20 Nov 2010

Ethicon submits BLA to FDA for Fibrin Pad

Ethicon, Inc., a worldwide leader in surgical care, announced today that the company has submitted a Biologic License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the Fibrin Pad, a novel product candidate that combines Ethicon's biomaterials and plasma-derived biologics (Human Fibrinogen and Human Thrombin), to aid in stopping soft tissue bleeding during surgery.

19 Nov 2010

Multidisciplinary clinic approach can improve survival in patients with aggressive prostate cancer

A research team from the National Cancer Institute (NCI) designated Kimmel Cancer Center (KCC) at Jefferson has concluded for the first time that a multidisciplinary clinic approach to aggressive prostate cancer can improve survival in patients. The results from the 15-year study of the multidisciplinary clinic can be found in the November issue of Journal of Oncology Practice.

18 Nov 2010

ESWL should be first choice for removing smaller kidney stones in distal ureter

Different techniques should be used to remove single stones that have become lodged in the distal ureter after being expelled by the kidney, depending on whether they are under or above one centimetre, according to the December issue of BJUI.

18 Nov 2010

Exelixis reports interim data of XL184 for metastatic castration-resistant prostate cancer

Exelixis, Inc. today reported interim data from the cohort of patients with metastatic castration-resistant prostate cancer (CRPC) treated with XL184 in an ongoing phase 2 adaptive randomized discontinuation trial (RDT).

18 Nov 2010

OmniVision commences mass production of OV6930 medical image sensor

OmniVision Technologies, Inc., a leading developer of advanced digital imaging solutions, today announced the initiation of mass production of the ultra-compact, high-performance OV6930. With a packaged footprint of only 1.8 x 1.8 mm, the OV6930 is the ideal solution for applications favoring a small profile.

18 Nov 2010

Predictive Biosciences, Epigenomics extend GSTP1 licensing agreement for prostate cancer

Epigenomics AG , the cancer diagnostics company, and Predictive Biosciences, a commercial stage, fully-integrated developer of novel molecular diagnostic cancer assays and a provider of anatomic pathology laboratory products and services, today announced that they have extended their licensing agreement for the prostate cancer biomarker GSTP1, originally signed in April 2009.

17 Nov 2010