Manufacturing

FDA advocates building quality into a product through PAT.

Many compounds fail in preclinical development because of safety-related problems, but identifying 'predictable' safety or toxicity liabilities earlier in the process could lead to improved design and selection of compounds that are more likely to be approved.

Merck plans to cut approximately 7200 positions as part of its 2008 restructuring plan, according to an Oct. 22 release focused on the company's third-quarter financial results.

Pfizer and Lilly recently resolved issues related to their marketing practices for certain products.

Also, Maxygen looks to costs, jobs; Receptor BioLogix appoints Dale R. Pfost CEO; more...

Pfizer and UCB formed a technology company named Cyclofluidic with the aim of accelerating the drug-discovery process.

The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.

Rep. John D. Dingell (D-MI), chairman of the US House of Representatives Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), chairman of the Oversight and Investigations Subcommittee, sent letters to the US Food and Drug Administration, Shaw Science Partners, and EthicAd to request information about a new FDA website.

Also, MedImmune opens Cambridge, UK, facility and makes reverse engineering pact with Omninvest; BD Medicine appoints Carol Adiletto VP of clinical and regulatory affairs; more...

Also, Millipore opens new membrane-casting manufacturing facility in Ireland; Surface Logix appoints Keith Dionne president, CEO, and a member of the board; more...

According to a July 11, 2008 memorandum posted by the Center for Biologics Evaluation and Research, starting Oct. 15, Health Level 7 structured product labeling in XML (extensible markup language) will be the only acceptable presentation in electronic format for the submission of content of labeling that CBER can process, review, and archive.

FDA has completed its labeling updates to fluoroquinolone antimicrobial drugs.

At a public meeting, the Medicare Payment Advisory Commission (MedPAC) discussed its recommendation that Congress establish a national database to publicly reveal financial relationships between physicians and the pharmaceutical industry.

John Dingell (D-MI), chairman of the US House Committee on Energy and Commerce and Bart Stupak (D-MI), chairman of that committee's Subcomittee on Oversight and Investigations, directed a letter to US Food and Drug Administration Commissioner Andrew C. von Eschenbach to request further information regarding FDA's process for inspecting manufacturing facilities of the generic drug manufacturer Actavis following several product recalls by the company.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the October 2008 edition from Cognex and W.L. Gore and Associates.

Vacuum-conveying technology is commonly used in the pharmaceutical industry to move materials through the processing line, blend ingredients in various solutions, and handle tablets. The vacuum conveying of powders and granules, however, must be performed properly to avoid segregation, the separation of ingredients that results in an uneven mixture.

Integrating MES with enterprise resource planning (ERP) systems can bring companies greater control over production than before and make manufacturing processes more flexible.

Under a definitive merger agreement, Eli Lilly and Company will acquire ImClone Systems, Inc. (New York) in a cash tender offer of approximately $6.5 billion.

The electronic pedigree mandate for prescription drugs has been delayed again. California Gov. Arnold Schwarzenegger signed legislation that delays ePedigree implementation until 2015.

Also, Merck & Co. discontinues development of its obesity drug taranabant; Synthetech names Frederic Farkas director of manufacturing; more...

Several strategies and software applications help pharmaceutical companies integrate their manufacturing execution systems and enterprise resource planning systems.

Pharmaceutical companies want software vendors to make integrating manufacturing execution systems and enterprise resource planning systems easier.

Industry needs a standard to connect systems and equipment sooner rather than later.

The authors studied the effect of the combination of binders on the flow and compressibility characteristics of the agglomerates of binary combination of lactose and dibasic calcium phosphate dihydrate.

In the wake of economic growth, healthcare reforms, and large-scale industry investment, Turkish pharmaceutical companies are charting their own destiny.