Articles by Amy Ritter - Pharmaceutical Technology

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Articles by Amy Ritter

PhRMA Transitions Management of its Benefit–Risk Action Team

Feb 2, 2012

PhRMA announced that it will transition the management of its benefit–risk action team to the Centre for Innovation in Regulatory Science (CIRS). CIRS is a neutral, independent UK-based subsidiary company, forming part of the Intellectual Property and Science business of Thomson Reuters.

Genzyme Plant Approved to Begin Manufacture of Drug in Critically Short Supply

Jan 26, 2012

Sanofi's subsidiary Genzyme has received FDA's approval for the production of Fabrazyme (agalsidase beta), used in the treatment of Fabry's disease, at its manufacturing facility in Framingham, Massachusetts. Shortages of Fabrazyme have been ongoing for the past two years.

AstraZeneca and IMS Health Announce Data and Research Collaboration

Jan 19, 2012

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

USP Announces Proposed Standard for Supply-Chain Integrity

Jan 12, 2012

The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.

NIH Establishes National Center for Advancing Translational Sciences

Jan 5, 2012

The National Institutes of Health has established the National Center for Advancing Translational Sciences, a center dedicated to the translation of scientific discoveries into new drugs, diagnostics, and devices.

Antibody-Drug Conjugates: Looking Ahead to an Emerging Class of Biotherapeutic

Creating a successful antibody-drug conjugate requires careful selection of the drug, antibody, and linker.
Jan 2, 2012

Creating a successful antibody-drug conjugate requires careful selection of the drug, antibody, and linker.

GAO Recommends Strengthening FDA's Ability to Respond to Shortages

Dec 22, 2011

The Government Accountability Office issued a report recommending that FDA's ability to respond to drug shortages be strengthened. The report was released in conjunction with a Senate hearing before the Committee on Health, Education, Labor, and Pensions on Dec. 15, 2011, on the subject of drug shortages.

AstraZeneca to Expand Presence in China

Dec 15, 2011

AstraZeneca entered into an agreement to acquire Guangdong BeiKang Pharmaceutical, a privately owned generic-drug manufacturing company based in China, for an undisclosed amount. Upon completion of the acquisition, AstraZeneca will be responsible for the manufacture and commercialization of these medicines.

FDA Announces Public Meeting to Discuss Biosimilar User Fees

Dec 8, 2011

On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
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Protecting the supply chain
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Reducing drug shortages
Breakthrough designations
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Expedited reviews of drug submissions
More stakeholder involvement
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