Feb 2, 2012
By:
Amy Ritter
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.
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Jan 26, 2012
By:
Amy Ritter
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.
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Jan 19, 2012
By:
Amy Ritter
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.
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Jan 12, 2012
By:
Amy Ritter
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.
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Jan 5, 2012
By:
Amy Ritter
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.
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Creating a successful antibody-drug conjugate requires careful selection of the drug, antibody, and linker.
Jan 2, 2012
By:
Amy Ritter
Creating a successful antibody-drug conjugate requires careful selection of the drug, antibody, and linker.
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Dec 22, 2011
By:
Amy Ritter
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.
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Dec 15, 2011
By:
Amy Ritter
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.
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Dec 8, 2011
By:
Amy Ritter
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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