The latest business, scientific & regulatory news from the pharmaceutical and biotechnology industries. Trends & international news from global correspondents and breakthroughs in research in Coming Down the Pike.
May 21, 2012
By:Jennifer Markarian
Human Genome Sciences rejects GlaxoSmithKline offer to acquire the company and issues a poison pill to prevent a takeover.
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May 17, 2012
By:Stephanie Sutton
ePT--the Electronic Newsletter of Pharmaceutical Technology
AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen Pharmaceutica NV, Merck Serono, and Pfizer have pledged support of more than £14 million ($23 million) to a translational drug development project being run by the UK's Medical Research Council and the University of Dundee.
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May 16, 2012
By:Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology
ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process.
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May 16, 2012
By:Amy Ritter
ePT--the Electronic Newsletter of Pharmaceutical Technology
Senators Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) send letters to opoid manufacturers and pain groups asking them to disclose financial ties.
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May 15, 2012
By:Susan Haigney
ePT--the Electronic Newsletter of Pharmaceutical Technology
The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.
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May 14, 2012
By:Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology
GlaxoSmithKline tenders offer of $13.00 per share in an unsolicited bid despite an earlier rejection by Human Genome Sciences.
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May 10, 2012
By:Stephanie Sutton
ePT--the Electronic Newsletter of Pharmaceutical Technology
The European Federation of Pharmaceutical Industries and Associations has formally adopted a memorandum of understanding with key partners for a harmonized, European system for medicines verification.
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May 9, 2012
By:Amy Ritter
ePT--the Electronic Newsletter of Pharmaceutical Technology
Abbott Laboratories will pay $1.6 billion to settle outstanding issues concerning past sales and marketing practices for its neurologic medication, Depakote.
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May 8, 2012
By:Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.
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