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Latest From Oriel Therapeutics Inc.

Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted

The latest regulatory news on new versions of complex products and delivery systems from our FDA Performance Tracker.

Approvals Biosimilars

Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted

The latest regulatory news on new versions of complex products and delivery systems from our FDA Performance Tracker.

Approvals Biosimilars

Deals Shaping the Medical Industry (05/2010)

The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Elsevier's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.

Rediscovering Existing Drugs

There's been a lot of talk lately about unlocking the hidden value from existing products, that is, drugs that have gone all the way from pure discovery, through the FDA regulatory process and into the hands of patients. These are the industry's greatest assets; they've already distinguished themselves from millions of other compounds by passing the myriad tests related to disease relevancy, safety, efficacy, and more safety, since safety isn't ultimately known until drugs disseminate through the treatment population, years after approval. Recently, there's been a shift to applying the industrial revolution in de novo drug discovery--the tools for screening and assaying libraries of random compounds-to existing drugs, as companies look for new products by reprofiling, repurposing, and redirecting the development of old drugs.

BioPharmaceutical Business Strategies
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