Regulation     Home About Us Biotech/Pharma Careers Clinical Trials FDA Medicare/Managed Care New Drug Applications Regulation Stock Selection Contact Us   Hot News           Info Box   Six-Month Prostate Cancer Treatment Wins FDA Approval The FDA has approved Watson Pharmaceuticals’ Trelstar for advanced prostate cancer, a palliative treatment that is only taken twice a year and does not require refrigeration. Pfizer Pipeline Faces Three Late-Stage Cancer Drug Setbacks Pfizer was hit with three oncology-related R&D setbacks last week, including the discontinuation of a Phase III trial of a lung cancer treatment. FDA Releases Amylin’s Form 483 Ahead of NDA Decision The Amylin Pharmaceuticals facility, which plans to manufacture Eli Lilly’s diabetes drug Byetta if it gets approval, has received an FDA Form 483 with 10 observations. Teva Sues Mylan Over Seasonique, LoSeasonique ANDAs Teva Women’s Health has filed two patent infringement suits against Famy Care and Mylan Pharmaceuticals over generic versions of Teva’s oral contraceptives Seasonique and LoSeasonique. Plavix Boxed Warning Highlights Lack of Efficacy in Some Patients Sanofi-Aventis and Bristol-Myers Squibb’s blockbuster anti-clotting drug Plavix will now carry a boxed warning about the drug’s ineffectiveness in some patients with a genetic mutation. Industry May Face Expanded Disclosure of PBM Financial Ties Drugmakers may be required to disclose more information on their financial relationships — this time with pharmacy benefit managers (PBMs) — if an expanded version of Sen. Chuck Grassley’s (R-Iowa) transparency legislation is passed. Full Issue View the entire issue. FDA Finds No Fracture Link to Osteoporosis Drug Class The FDA is reacting rapidly to concerns about osteoporosis drugs like Merck’s Fosamax, saying the drugs show no clear connection to thigh fractures. Biovail Sues Paddock Over Generic Aplenzin ANDA Biovail Laboratories International sued Paddock Laboratories after it filed an ANDA with a Paragraph IV certification to market a generic Aplenzin ER antidepressant.   Copyright © 2006. BioHQ.com. All rights reserved.