Articles by Amy Ritter - Pharmaceutical Technology

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Articles by Amy Ritter

FDA Issues Warning Letter to IntelliCell Biosciences

Mar 29, 2012

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.

FDA Warns Teva Pharmaceuticals About Improper Promotional Materials

Mar 22, 2012

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.

GE Healthcare to Acquire Xcellerex

Mar 15, 2012

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.

BI Expands Biomanufacturing Capacity in Europe

Mar 8, 2012

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.

FDA Encourages Whistleblowers, Just Not Its Own

FDA's treatment of whistleblowers lacks internal consistency.
Mar 2, 2012

FDA's treatment of whistleblowers lacks internal consistency.

Merck KGaA Announces Restructuring

Mar 1, 2012

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.

FDA Issues Warning Letters for Three Merck KGaA Plants

Feb 23, 2012

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.

FDA Releases Draft Guidance on Monitoring Crude Heparin for Quality

Feb 16, 2012

FDA has released a draft guidance for API manufacturers in response to a 2008 incident in which heparin sourced from China was adulterated with oversulfated chondroitin sulfate, causing serious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.

GlaxoSmithKline Tracks R&D Performance

Feb 9, 2012

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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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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