Articles by Patricia Van Arnum - BioPharm International

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Articles by Patricia Van Arnum

Novartis Suffers Setback in Indian Patent Case for Glivec

Apr 2, 2013

Novartis loses an appeal in seeking patent protection in India for its anticancer drug.

CROs in a Global State of Mind

CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry.
Mar 2, 2013

CROs are keeping pace with the increased globalization of the biopharmaceutical/pharmaceutical industry.

Advancing Analytical Testing and Instrumentation for Biopharmaceuticals

As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.
Mar 1, 2013

As biopharmaceutical/pharmaceutical companies increase their development of biologic-based drugs, companies providing analytical instrumentation and laboratory testing goods and services are, in turn, offering improved tools for biologic characterization, biomanufacturing, and related testing.

Advances in PAT for Parenteral Drug Manufacturing

Applying QbD and PAT facilitates process understanding in lyophilization.
Mar 1, 2013

Applying quality-by-design and process analytical technology facilitates process understanding and control of various operations in lyophilization.

FDA Approvals of NMEs and BLAs Increased in 2012

Jan 2, 2013

Additional approvals in December have helped to outpace a recent high set in 2011.

FDA Issues Final Guidance on Limiting the Use of Certain Phthalates as Excipients

Dec 21, 2012

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

FDA Issues Draft Guidance on Electronic Submissions

Dec 18, 2012

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

US Supreme Court to Hear Myriad Genetics' Gene Patentability Case

Dec 4, 2012

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

Janssen, Merck, and Eli Lilly Form Industry Collaboration

The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.
Nov 19, 2012

The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.

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