Pharmaceutical Compliance Monitor

FDA Advisory Committee Supports Approval of Gilead’s Once-Daily Quad Single Tablet Regimen for HIV

Expert — Thu, 17 May 2012 12:06:40 +0000

– Final FDA Decision On The Quad Anticipated Late Summer – FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 13 to 1 in support of approval of the Quad, a complete single tablet regimen of elvitegravir, [...]

Mitigating the Risks in Big Pharma M&A

Andreas Scherer — Wed, 16 May 2012 12:55:50 +0000

Andreas Scherer, Ph.D. We have seen a number of major mergers and acquisitions among pharmaceutical companies over the last few years. Is long term success in this industry an issue of size? And most importantly how do we mitigate the risk of large M&A transactions? This article will take a look at the reasons why [...]

US and EU Regulatory Authorities Accept Oral BG-12 Marketing Applications for Review

Expert — Tue, 15 May 2012 12:31:02 +0000

WESTON, Mass.–(BUSINESS WIRE)– Today Biogen Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory authorities have accepted the company’s marketing applications for the review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of multiple sclerosis (MS). The U.S. Food and Drug Administration (FDA) has accepted Biogen Idec’s New Drug Application (NDA) for [...]

Addressing the Voice of the Patient

Dr. Nancy Dreyer — Mon, 14 May 2012 13:16:00 +0000

Dr. Nancy Dreyer In the multi-stakeholder, evidence-based healthcare environment of today, patient-reported outcomes (PRO) are becoming an increasingly important tool for drug developers to better demonstrate the real-world value of medications. As with nearly all other types of observational research, PRO provide clinicians, payers and regulators with additional data not only with regard to safety [...]

Mylan Announces Settlement Agreement for its First-to-File Generic Version of Nuvigil®

Expert — Thu, 10 May 2012 06:03:07 +0000

PITTSBURGH, April 30, 2012 /PRNewswire via COMTEX/ — Mylan Inc. MYL -0.24% today announced that it has entered into a settlement agreement with Teva that will resolve pending patent litigation related to Nuvigil® (Armodafinil Tablets, 50 mg, 150 mg, and 250 mg). The settlement allows Mylan to begin selling generic versions of 50 mg, 150 [...]