Drug Substance Analysis

Also, Alpharma advises shareholders to reject King's offer; ImClone rejects raised BMS offer; Immunogen appoints Daniel M. Junius, more...

The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.

Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more...

EPedigree, track-and-trace technologies, and other tools for optimizing supply-chain management are of increasing importance to the pharmaceutical industry. The author examines the current regulatory and legislative framework for ePedigree for finished drug products as well as proposals to require electronic statements for pharmaceutical ingredients.

Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, is announcing a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

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.

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

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.

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

Also, Pall plans expansion in South America, Anthony Clarke joins Alexza Pharmaceuticals, more...

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

Also, FDA removes OAI status for Watson's Florida facility, executive management changes as GSK, more...

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

Also, Alcon plans to open Singapore facility, Pharmacopeia president and CEO retired, more...

Also, VaxGen and Raven terminate merger agreement, Darren Head appointed CEO of Cytovance, more...

Also, Alkermes announces restructuring and reduction of workforce, Icagen announces several senior management promotions, more...

Also, Pipex Pharmaceuticals implements cost-cutting measures, Pfizer's Senior Vice-President and General Counsel Allen Waxman leaves the company, more...

Also, PDL BioPharma will no longer pursue sale of the company, executives resign from Topigen Pharmaceuticals, more...

Also, Millipore plans to open Singapore facility, Michael J. Simms joins Alexza Pharmaceuticals, more...

The European Union's REACH initiative has the potential to affect the flow of chemicals into the pharmaceutical suppy chain.

Amira and GSK Form Agreement, Xenome Appoints Ian Nisbet CEO, More...

Merck Sells Facility to Cherokee Pharmaceuticals, Inflazyme Announces Senior Management Resignations, More...

The authors propose extending initial solvent screening for a single-solvent system to the cocktail solvent screening of binary and ternary solvent mixtures.

Company and People Notes: West to reduce workforce, Eli Lilly's CEO and chairman to retire, more...

Company and People Notes: ISP to raise prices, Patheon appoints CEO, more.

Orally disintegrating tablets (ODTs) continue to attract attention as an alternative to conventional oral dosage forms.

Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More.

Double-digit growth is projected for the US generic drug market, and the industry positions for opportunities in biosimilars.

Brussels (Feb. 13)-The European Generic Medicines Association raised concerns over what it terms ?the serious lack? of resources available to member states in the European Union (EU) to deal with the regulatory workload and bottleneck in new registrations caused by the new Decentralized Procedure (DCP) for approving drugs in Europe.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?