Mar 29, 2012
By:
Amy Ritter
On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act, and for violations of cGMP and Good Tissue Practice in the manufacture of its adipose tissue-derived stem-cell product.
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Mar 22, 2012
By:
Amy Ritter
Teva Pharmaceuticals received a Warning Letter from FDA informing them that promotional materials as well as an associated webpage for Copaxone (glatiramer acetate injection) solution for subcutaneous injection were found to be false and misleading.
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Mar 15, 2012
By:
Amy Ritter
On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.
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Mar 8, 2012
By:
Amy Ritter
Boehringer Ingelheim (BI) has announced the expansion of its biopharmaceutical manufacturing capabilities at its plants in Biberach, Germany and in Vienna, Austria. The expansion will include cell-culture and microbial-fermentation capacity, and support cell-line and process-development services for BI's contract manufacturing business.
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FDA's treatment of whistleblowers lacks internal consistency.
Mar 2, 2012
By:
Amy Ritter
FDA's treatment of whistleblowers lacks internal consistency.
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Mar 1, 2012
By:
Amy Ritter
Merck KGaA announced measures intended to reduce costs and increase efficiency to ensure the long-term success of its business model. The measures announced this week are part of a comprehensive transformation program that will be implemented in two phases.
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Feb 23, 2012
By:
Amy Ritter
On Feb. 21, 2011, FDA posted a copy of a Warning Letter that was sent to the chairman of the executive board of Merck KGaA on Dec. 15, 2011, regarding cGMP violations identified at three of its European facilities: MS-Corsier-sur-Vevey, MS-Aubonne, and MS-Tiburtina.
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Feb 16, 2012
By:
Amy Ritter
FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious adverse reactions in patients.
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Feb 9, 2012
By:
Amy Ritter
GlaxoSmithKline released its fourth quarter and full year 2011 earnings report, which showed its return on R&D to be 12%—up from 11% in 2010, and closing in on the company's goal of a 14% return.
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