Manufacturing

The US Food and Drug Administration released its user fee rates for fiscal year 2009 last Friday.

Also, Bilcare Global Clinical Supplies opens new headquarters in San Francisco, Sigurdur Oli Olafsson named CEO of Actavis Group, more...

CMOs expand capacity and capabilities in high-potency manufacturing to meet strong demand for cytotoxic and other potent drugs.

Patent pressures, changing disease profiles, and higher costs force companies to fight for the top.

Agents report unusual chemistry, abnormal data analysis, and unconventional work practices.

This year's meeting of the Controlled Release Society unveiled a plethora of research insights.

Myth versus Reality: What does Q10 implementation really mean for my company?

Editors' Picks of Pharmaceutical Science & Technology Innovations

Legislative decisions to increase Medicare's formulary may lead to a fight over drug approvals.

FDA is modernizing adverse-event reporting as part of a revolution in drug-safety assessment.

After five years in the making, the official pharmaceutical quality system is here. All three parties to ICH adopted a final version of Q10 and agreed to implement the guideline through their individual regulatory bodies.

Postponement of California's deadline gives the supply chain time to refine ePedigree solutions.

Despite its flaws, a recent release fills a need for books about pharmaceutical project management.

The authors consider several common techniques for verifying the accuracy of liquid-handling equipment and offer guidance for finding the appropriate technique for a given instrument.

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.

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.

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.

Also, Cobra Biomanufacturing to extend collaboration and form joint venture with ViroMed, Epix Pharmaceuticals CEO resigns, more...

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.

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.

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.

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.

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.

Also, Niro changes its name to GEA Process Engineering; Frances K. Heller joins Exelixis as executive vice-president of business development, more...

Pfizer (New York, NY) announced plans to restructure staff at its Kalamazoo, Michigan, facility, leading to an estimated job cut of 275 by the end of the year.

Bristol-Myers Squibb (BMS) agreed to reduce the output of ozone-depleting refrigerants at several industrial facilities around the country to resolve violations of the Clean Air Act. The company's modifications will cost approximately $3.65 million.

Also, Roche to end HIV/AIDS research program, WuXi PharmaTech makes appointments, more...

Creating nanoparticles can be challenging and requires appropriate equipment and techniques. Media milling or grinding is the best-established manufacturing method for nanoparticle production.

A pharmaceutical company's information-technology infrastructure could facilitate the appraisal of the performance of contract manufacturing organizations.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the July 2008 edition from Parker Fluid Control Division and Watson-Marlow Bredel.