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Pharmaceutical sector round-up: Legal action dominates

By Tim Sandle     Mar 11, 2016 in Business
As we do at regular intervals, Digital Journal dips into the latest news stories relating to the colorful world of pharmaceuticals. This week there are new drugs announced and old scores to settle.
Starting off with new products, a flu drug made by AstraZeneca has been given fast-track status through the clinical trial process by the U.S. Food and Drug Administration (FDA). The approval is for an investigational human monoclonal antibody (mAb) product called MEDI8852. The novel drug is designed for the treatment of patients hospitalized with Type A strain influenza.
Speaking with Pharmaceutical Manufacturing magazine, Steve Projan, Senior Vice President, R&D and Infectious Diseases & Vaccines, stated: “We are pleased that the FDA has granted Fast Track designation for MEDI8852 as it recognizes the importance of accelerating the development of new medicines for the prevention and treatment of challenging infectious diseases.”
In another new move, the FDA has approved a Zika virus diagnostic test kit for emergency use, in sign of continued global concern about the spread of the disease. The test, called the Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay, was developed by the U.S. governmental organization the Centers for Disease Control and Prevention (CDC) and is intended to detect the presence of anti-Zika antibodies in a patient's blood or cerebrospinal fluid.
With acquisitions and mergers, the Indian pharma company Lupin has acquired a U.S. based company called privately-held GAVIS Pharmaceuticals and Novel Laboratories (GAVIS). This gives the Indian manufacturer its first foothold on U.S. soil. Lupin makes dermatology products, controlled substance products, and niche generic drugs.
On the legal battle front, German based pharmaceutical giant Merck is demanding another pharmaceutical company called Gilead pay out a colossal $3 billion in royalties for an anti-hepatitis B product. This is because a compound in Gilead’s products, called Sovaldi and Harvoni, have been found by a judge to have infringed Merck’s patents. The issue centers on whether the patents are still valid.
As a sign that pharma companies can sometimes get on, AstraZeneca and Roche are to get together for a cancer project. The companies are to jointly fund PatientsLikeMe, a cancer patient outcomes study. The study will examine patients' experiences with cancer treatments.
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