Articles by Chitra Sethi - BioPharm International

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Articles by Chitra Sethi

FDA Directs Amgen to Revise ESA Labeling

Aug 4, 2008

The FDA has ordered Amgen and Johnson & Johnson to make safety-related changes to the labeling of their erythropoeisis-stimulating agents (ESAs), Aransesp and Procrit.

Genentech Reviews Roche Proposal

Jul 25, 2008

Genentech, Inc., (South San Francisco, CA) has formed a special committee of its Board of Directors to assess the proposal from the Swiss drug-maker Roche (Basel, Switzerland) to take over the remaining shares of the American biotech giant.

Administration Proposes Additional $275 Million Funding for FDA

Jun 10, 2008

Health and Human Services Secretary Mike Leavitt has announced that his agency is amending its budget request for FY 2009 to include an additional $275 million for the FDA.

FDA Approves Expanded Adjuvant Indications for Herceptin

May 23, 2008

US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.

FDA to Recruit 1,300 Science and Medical Positions

Apr 30, 2008

The US FDA has embarked on a multiyear initiative to hire hundreds of individuals with science and medical backgrounds to help meet the agency?s responsibilities to ensure the safety and efficacy of human and veterinary drugs, biological products, medical devices, food, and cosmetics.

Takeda to Acquire Millennium for $8.8 Billion

Apr 11, 2008

Takeda Pharmaceutical Company Limited (Osaka, Japan) will acquire Millennium Pharmaceuticals, Inc. (Cambridge, MA), for approximately $8.8 billion through a cash tender offer of $25.00 per share.

FDA Issues Guidance Defining Key Terms in Pharmacogenomics

Apr 9, 2008

In its effort to ensure that consistent definitions of terminology are being applied by all constituents of the ICH, the FDA has released a new guidance, E15, containing definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics.

FDA Approves Regeneron's Acralyst

Mar 6, 2008

The US FDA has approved Arcalyst (rilonacept, an interleukin-1 blocker) for the long-term treatment of two cryopyrin-associated periodic syndrome (CAPS) disorders.

Two Biotech Drugs Approved for New Indications

Feb 28, 2008

On February 22, 2008, the FDA approved two biotech drugs, Avastin (bevacizumab) and HUMIRA (Adalimumab), for additional indications.

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