Current environment: Vioxx casts a beleaguered drug industry

Article Abstract:

An analysis on Vioxx, a popular arthritis drug manufactured by Merck and Co., Inc. that was recalled from the market due to its linkage to heightened cardiovascular risks is resented. This incident created quite a stir in the industry with Merck having to face with major hurdles such as recalling the product from the market, which in turn brought down the stock prices of the company and facing lawsuits from patients. With many pharmaceutical companies facing major patent expirations, and in addition Food and Drug Administration giving approval for a new drug within eight to ten years, pharmaceutical organizations have turned to contract research organizations (CROs) that assist pharmaceutical and biotechnology companies in developing and taking drug compounds through clinical trials as well as through regulatory trials.

Product standards, safety, & recalls, Contracts & orders received, Pharmaceutical Preparation Manufacturing, Securities issued, listed, Contracts & orders let, Antiarthritic Analgesic Preps, Industry Overview, Product defects and recalls, Contracts, Securities, Contract agreement, Company securities, Vioxx (Medication), Antiarthritic agents, Merck & Company Inc.

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Pfizer petitions FDA to reject Sandoz' filing for Omnitrop

Article Abstract:

A citizen petition has been filed by Pfizer requesting United States Food and Drug Administration authorities to reject Sandoz' New Drug Application (NDA) using a version of Pfizer's human growth hormone, i.e., Genotropin (somatropin), as injection (Omnitrop on the grounds that the data furnished on Omnitrop was insufficient to support its approval. Sandoz has responded stating that its potential follow-on biologics met the required standards.

Switzerland, Services information, CHEMICALS AND ALLIED PRODUCTS, Services, Pfizer Inc., Chemical industry, PFE, United States. Food and Drug Administration, Pesticides industry, Herbicides, Sulphur industry, Sandoz Ltd.

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Court says foreign vitamin plaintiffs cannot sue in United States

Article Abstract:

United States supreme court ruling in the F Hoffmann-La Roche v Empagran SA case that foreign purchasers of vitamins manufactured by non-US companies cannot sue in US courts has been analyzed. The judgement could entail reciprocal antitrust enforcement efforts in other countries.

Government regulation (cont), Government regulation, Laws, regulations and rules, International aspects, Industrialists, Vendors and purchasers (Law)

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