Articles by Amy Ritter, PhD - BioPharm International

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Articles by Amy Ritter, PhD

ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design

Sep 24, 2012

ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.

Discovery Pipeline: NIH Invests in Tissue Chips

NIH has awarded ten laboratories two-year grants to develop tissue chip technology, with part of the funding coming from the recently established National Center for Advancing Translational Science.
Sep 1, 2012

NIH has awarded ten laboratories two-year grants to develop tissue chip technology, with part of the funding coming from the recently established National Center for Advancing Translational Science.

Challenges and Opportunities for Biosimilars Developers

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.
Sep 1, 2012

Howard Levine of BioProcess Technology Consultants talks about what industry needs to know to enter the biosimilars game in the US.

Pfizer and Mylan Partner to Develop Generic Drugs in Japan

Aug 27, 2012

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

Grey-Market Distributor Convicted of Defrauding FDA

Aug 20, 2012

South Carolina-based Altec Medical pleaded guilty to one count of conspiring to defraud FDA and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.

Elan to Spin Off Discovery Sciences

Aug 13, 2012

Elan Corporation announced plans to spin off its discovery unit and Neotope Biosciences division to create an independent entity focused on R&D.

Gilead Partners with Indian Manufacturers on HIV Medicines

Aug 6, 2012

Gilead Sciences announced that it is entering into agreements with Indian generic drug manufacturers to enhance access in developing countries to its anti-HIV medicine, emtricitabine.

Discovery Pipeline: Topical Delivery of siRNA

A team from Northwestern University has demonstrated the feasibility of topical delivery of small interfering RNA (siRNA).
Aug 1, 2012

A team from Northwestern University has demonstrated the feasibility of topical delivery of small interfering RNA (siRNA).

Merck Serono to Spin Off Parkinson's R&D

Jul 30, 2012

First start-up funded by Merck Serono's Entrepreneur Partnership Program announced.

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