- FDA authorizes StemCells to conduct trial of product candidate in patients with age-related macular degeneration
- Bayer receives approval to begin expanded access program for investigational prostate cancer therapy
- FDA removes clinical hold on trial of Idenix's investigational HCV therapy
- Discovery Labs' aerosol drug delivery system approved
- Merck's Janumet XR approved for type 2 diabetes
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
Bayer receives approval to begin expanded access program for investigational prostate cancer therapy
What's This?
The Food and Drug Administration agreed to allow Bayer HealthCare LLC to proceed with the company's expanded access program to provide the investigational drug radium-223 chloride to patients with castration-resistant prostate cancer/hormone-refractory prostate cancer with symptomatic bone metastases. An expanded access program permits, under certain circumstances, the use of an investigational drug in patients with a serious disease or condition who cannot participate in a controlled...
The Food and Drug Administration agreed to allow Bayer HealthCare LLC to proceed with the company's expanded access program to provide the investigational drug radium-223 chloride to patients with castration-resistant prostate cancer/hormone-refractory prostate cancer with symptomatic bone metastases.
An expanded access program permits, under certain circumstances, the use of an investigational drug in patients with a serious disease or condition who cannot participate in a controlled clinical trial of the drug.
Radium-223 chloride will now be made available to patients through qualified clinical sites that participate in the expanded access program.
Astellas, Medivation's investigational prostate cancer drug meets primary, secondary endpoints of Phase III AFFIRM trial 
What's This?
Astellas Pharma Inc. and Medivation Inc.'s MDV3100 met all primary and secondary efficacy endpoints of the Phase III AFFIRM trial among men with prostate cancer who previously received chemotherapy, according to data being presented this week in San Francisco at the 2012 Genitourinary Cancers Symposium. The double-blind trial included...
Research favors early initiation of 5ARI therapy for patients with BPH
What's This?
For the treatment of benign prostatic hyperplasia (BPH), early rather than delayed initiation of 5-alpha reductase inhibitor (5ARI) therapy, either as monotherapy or in combination with alpha-adrenergic blockers (ABs), is associated with a reduced risk of clinical progression and lower BPH-related medical charges, according to findings from a retrospective analysis.The analysis included data for 224 men aged 50 years or older who received treatment for BPH between 2000 and...
FDA committee to review Amgen's sBLA for Xgeva, Cell Therapeutics' NDA for pixantrone next month
What's This?
The Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) will review Amgen Inc.'s supplemental Biologics License Application (sBLA) for Xgeva (denosumab) and Long-term study shows durable effects of Novasys Medical's Renessa as treatment for SUI in women
What's This?
Novasys Medical Inc.'s Renessa treatment for stress urinary incontinence (SUI) is associated with long-term improvement in SUI symptoms and incontinence-related quality of life (QOL), according to new study data.The Renessa system is an office-based procedure that is performed with local anesthetic and involves nonsurgical transurethral radiofrequency collagen denaturation. The Food and Drug...
- Astellas' NDA for overactive bladder treatment accepted for review
- Antares' overactive bladder treatment approved
- FDA committee to review Amgen's sBLA for Xgeva, Cell Therapeutics' NDA for pixantrone next month
- Long-term study shows durable effects of Novasys Medical's Renessa as treatment for SUI in women
- Taris Biomedical initiates midstage trial of investigational therapy for interstitial cystitis
- Celgene to end Phase III prostate cancer trial
- Astellas, Medivation's investigational prostate cancer drug meets primary, secondary endpoints of Phase III AFFIRM trial
- Salix Pharmaceuticals to acquire Oceana Therapeutics for $300 million
- Research favors early initiation of 5ARI therapy for patients with BPH
- Taris Biomedical initiates midstage trial of investigational therapy for interstitial cystitis
