Manufacturing

Aug 01, 2008
Pharmaceutical Technology
The high-profile case of contaminated heparin from a Chinese supplier has intensified the debate on the effectiveness of FDA's process for inspecting foreign drug-manufacturing facilities. The article examines proposed legislative and regulatory reforms and actions taken by the agency to improve drug-import safety.
Aug 01, 2008
Pharmaceutical Technology
A sponsor company must investigate the manufacturing automation and systems, laboratory automation and systems, information-technology infrastructure, and business applications of each potential contract manufacturing organization.
Jul 31, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Senator Sherrod Brown sent a letter to Richard T. Clark, president and chief executive officer of Merck (Whitehouse Station, NJ), to ask for information about the company's reliance on global outsourcing for the manufacture of pharmaceutical ingredients and finished products.
Jul 31, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
As part of a new strategic direction, GlaxoSmithKline CEO Andrew Witty outlined three priorities that are designed to improve the company's long-term financial performance.
Jul 31, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Pharmaceutical companies developing new drug candidates for Hepatitis C virus infection now can test their compounds with a novel culture system that mimics the biology of HCV infection in humans.
Jul 31, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Also, Cobra Biomanufacturing to extend collaboration and form joint venture with ViroMed, Epix Pharmaceuticals CEO resigns, more...
Jul 31, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
The European Medicines Agency recommended strengthening the warnings for oral moxifloxacin medicines and concluded that these drugs should only be prescribed to treat acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and community-acquired pneumonia when other antibiotics cannot be used or have failed.
Jul 24, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Also, Niro changes its name to GEA Process Engineering; Frances K. Heller joins Exelixis as executive vice-president of business development, more...
Jul 24, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
Roche plans to acquire the biopharmaceutical company Genentech (South San Francisco, CA) for $43.7 billion. Roche currently holds a 55.9% stake in Genentech and it plans to acquire the remaining publicly held minority interest that it does not own for $89 per share.
Jul 24, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Teva Pharmaceutical Industries and Barr Pharmaceuticals (Montvale, NJ) signed a definitive agreement under which Teva will acquire Barr, the fourth-largest generic-drug company in the world. Teva will buy each share of Barr common stock for $39.90 in cash and 0.6272 Teva shares. Based on the closing price of Teva?s shares on July 16, 2008, the price per share of Barr common stock is $66.50, and the total value of the acquisition is $7.46 billion. Teva will assume Barr?s outstanding net debt of approximately $1.5 billion.
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