PharmExec Blog

EMA States Position on Confidential Information

In response to a letter the European Medicines Agency received from the European Ombudsman on Oct. 27, 2014, the agency is clarifying its policy on commercially confidential information. EMA states in its response that the agency is responsible for ruling on redactions of published documents and bases its decisions in accordance with laws and internal rules. Read More »

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J&J Strengthens Infectious Disease Pipeline with Alios Acquisition

Johnson & Johnson completed the acquisition of Alios BioPharma, a privately held clinical-stage biopharmaceutical company focused on developing therapies for viral diseases, for a total purchase price of approximately $1.75 billion in cash. Alios BioPharma will become part of the infectious diseases therapeutic area of the Janssen Pharmaceutical Companies of Johnson & Johnson.

The acquisition includes Alios BioPharma’s portfolio of potential therapeutics for viral infections with the promising compound AL-8176, an orally administered antiviral therapy currently in Phase II studies for the treatment of infants with respiratory syncytial virus (RSV). RSV is the last of the major pediatric diseases that currently has no effective therapy. The acquisition also includes two early-stage compounds for hepatitis C (HCV) that could potentially augment Janssen’s existing HCV portfolio.

Source: Johnson & Johnson

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Merck CEO Outlines Next Two Years as IFPMA President, Raises Ire on IP

Merck KGaA CEO Stefan Oschmann spoke last week in New York as he accepted the two-year role as president of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the R&D industry’s global trade group based in Geneva. Read More »

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Setting Biotech Standards in India

The past decade has seen considerable growth in the Indian pharmaceutical industry. The country has emerged as a key supplier of high quality and affordable medicines not only to the developing world, but also to developed economies. The sector has recorded a compound annual growth rate (CAGR) of 13.5% over the past five years and is projected to reach $45 billion in 2020.

With the ongoing shift from small molecules to biologics, the Indian biopharmaceutical industry is also set to replicate the success received by the Indian pharmaceutical companies. The biopharmaceuticals market has witnessed the fastest growth in the 2013 financial year as compared to other biotech markets (e.g., Bio-Agri, Bio-Services, and Bio-Informatics).

In this BioPharm International article, the authors report on the key role the Indian Pharmacopoeia Commission (IPC) is playing in securing the future of Indian biotech.

Read more…

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Industry Growth Slowdown in Brazil

rio--gettyimagesBy Hellen Berger.

The Brazilian economy is being impacted by internal and external factors, and forecast figures are being quickly revised downwards. Market research released by Brazil’s Central Bank revised average analysts’ projections for economic growth in 2014 down to 0.70% from 0.90% four weeks earlier(1). In June 2014, the Hong Kong Trade Development Council (HKTDC) stated that the local economy was projected to grow by 1.8% in 2014. Projection figures keep slipping on a weekly basis(2). Read More »

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