Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.
Mar 2, 2012
By:
Erik Greb, Amy Ritter, PhD
Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.
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Jan 3, 2012
By:
Erik Greb
On Dec. 21, 2011, Ranbaxy Laboratories signed a consent decree with FDA and pledged that it would strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. The agreement is subject to approval by the US District Court for the District of Maryland.
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Jan 3, 2012
By:
Erik Greb
On Dec. 22, 2011, Baxter International and Momenta Pharmaceuticals entered into a global collaboration to develop and commercialize follow-on biologic products. Baxter will contribute its clinical-development and biologic-manufacturing expertise, experience with sterile injectables, and global commercial capabilities to the collaboration. Momenta will bring its expertise in high-resolution analytics, characterization, and product and process development to the joint effort.
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Dec 20, 2011
By:
Erik Greb
In a Warning Letter, FDA cited ?significant violations? of CGMP regulations, including several repeat observations, at three Novartis facilities. The violations included failure to prevent microbiological contamination of sterile drug products, failure to investigate out-of-specification batches, failure to clean and maintain equipment, and failure to ensure drugs? identity, strength, quality, and purity.
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Dec 13, 2011
By:
Erik Greb
On Dec. 1, 2011, the Pharmaceutical Research and Manufacturers of America (PhRMA) Foundation awarded Johns Hopkins University and the University of Washington each a $250,000 grant to establish a three-year graduate certificate program.
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Dec 6, 2011
By:
Erik Greb
On Nov. 21, 2011, Gilead Sciences agreed to acquire Pharmasset for $137 per share in cash, or a total of approximately $11 billion. Pharmasset’s board of directors unanimously approved the transaction, which is expected to close during the first quarter of 2012. Gilead will finance the transaction with cash, bank debt, and senior unsecured notes.
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Nov 22, 2011
By:
Erik Greb
At a press conference held Nov. 10, 2011, FDA Commissioner Margaret Hamburg said the agency had approved 35 novel medicines in fiscal year 2011. Among the approved products were two drugs for late-stage metastatic melanoma and the first drug to treat Hodgkins lymphoma in 30 years. Other approvals included drugs to treat late-stage prostate cancer, thyroid cancer, metastatic breast cancer, and late-stage lung cancer.
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Nov 15, 2011
By:
Erik Greb
On Sept. 27, 2011, FDA sent Genentech a Form 483 listing several violations at the company?s South San Francisco, California, plant. The violations included problems with investigations into batch failures, inappropriate equipment design, and insufficient protection against contamination. FDA visited the plant, which produces the cancer drug Avastin, 13 times in September 2011 and made four observations.
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Nov 8, 2011
By:
Erik Greb
On Oct. 26, 2011, FDA dedicated $2 million to support two regional Centers of Excellence in Regulatory Science and Innovation (CERSI). The centers, which will be located at the University of Maryland and at Georgetown University, will focus on the scientific knowledge and training needed to modernize and improve the ways the agency reviews and evaluates drugs and medical devices.
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