Articles by Amy Ritter, PhD - BioPharm International



Articles by Amy Ritter, PhD

FDA Issues Warning Letter to IntelliCell Biosciences

Apr 3, 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 (FD&C Act), and for violations of cGMP and Good Tissue Practice (GTP) in the manufacture of its adipose tissue-derived stem-cell product.

GE Healthcare to Acquire Xcellerex

Mar 20, 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 13, 2012

Boehringer Ingelheim (BI) has announced in a press release the expansion of its biopharmaceutical manufacturing capabilities at its plants in Biberach, Germany and in Vienna, Austria.

Merck KGaA Announces Restructuring

Mar 6, 2012

Merck KGaA announced measures intended to reduce costs and increase efficiency to ensure the long-term success of its business model. The measures are part of a comprehensive transformation program that will be implemented in two phases. In the first two years, Merck plans to implement a new leadership organization, implement efficiency measures, and develop a long-term growth strategy. In the second phase, the company will explore new areas for growth. Cost savings from the first-phase efficiency measures are expected to fuel second-phase growth.

Considerations in Biopharmaceutical Outsourcing

Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.
Mar 2, 2012

Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.

FDA Releases Draft Guidance on Monitoring Crude Heparin for Quality

Feb 21, 2012

FDA has released a draft guidance for API manufacturers titled Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.

GlaxoSmithKline Tracks R&D Performance

Feb 14, 2012

GlaxoSmithKline (GSK) released its fourth quarter and full year 2011 earnings report on Feb. 7, 2012. In the report, the company tracks its R&D performance, and calculated the return on R&D to be 12%, up from 11% in 2010, and closing in on the company’s goal of a 14% return.

PhRMA Transitions Management of its Benefit-Risk Action Team

Feb 3, 2012

The Pharmaceutical Research and Manufacturers of America (PhRMA) announced that it will transition the management of its benefit?risk action team (BRAT) to the Centre for Innovation in Regulatory Science (CIRS), according to a press release. CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters. This transition is being made to further the program?s technical development and broaden input from the scientific community.

AstraZeneca and IMS Health Announce Data and Research Collaboration

Jan 24, 2012

On Jan. 11, 2012, AstraZeneca and IMS Health announced a three-year collaboration to use real-world healthcare data from Europe to guide AstraZeneca?s discovery and clinical development programs.



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