Articles by Patricia Van Arnum - BioPharm International

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Articles by Patricia Van Arnum

GlaxoSmithKline Plans Biopharmaceutical Manufacturing Investment in the UK

Apr 3, 2012

GlaxoSmithKline (GSK) plans to invest more than £500 million ($798 million) in the United Kingdom across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines.

FDA Commissioner Testifies for PDUFA Reauthorization

Feb 14, 2012

On Feb. 1, 2012, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V.

FDA Files Consent Decree Against Ranbaxy

Feb 3, 2012

The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The consent decree was filed against Ranbaxy Laboratories Ltd., an Indian corporation, and its subsidiary Ranbaxy Inc., headquartered in Princeton, New Jersey. The decree was filed on Jan. 25, 2012, and is subject to court approval.

Ben Venue Continues Suspension of Manufacturing Activity at Ohio Facility

Jan 10, 2012

Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.

Biogen Idec, Samsung Form Biosimilars Joint Venture

Dec 13, 2011

Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung?s latest effort to strengthen its position in biosimilars.

Merck & Co. Outlines Progress in Its Late-Stage Pipeline

Nov 22, 2011

Merck & Co. highlighted the key developments in its late-stage pipeline and its near-term plans for regulatory filings. The company has 19 candidates in Phase III clinical trials and plans to submit eight new US regulatory filings in 2012?2013, including five new drug candidates.

AstraZeneca Plans $200-Million Manufacturing Plant in China

Oct 18, 2011

AstraZeneca is investing $200 million in a new manufacturing site in China Medical City (CMC), Taizhou, Jiangsu province, China. The new site represents AstraZeneca?s largest investment in a single manufacturing facility globally.

Sanofi Outlines Long-Term Objectives

Sep 13, 2011

Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.

Murky Picture for Life-Science Financing in Second Quarter

Aug 23, 2011

The second quarter of 2011 presented a mixed picture of financing for the life-science sector, which includes the biotechnology and medical-device industries. Although venture-capital funding for the sector as a whole showed strong improvement, biotechnology investing dropped in terms of overall dollars invested and number of deals.

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