Also, NicOx and DSM make manufacture and supply pact for naproxcinod drug substance; NovaRx appointed Norrie Russell president and COO; more...

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

A Centers for Disease Control and Prevention (CDC) study confirmed that severe adverse reactions reported in the fall and winter of 2007 resulted from heparin contaminated with oversulfated chondroitin sulfate (OSCS).

The Environmental Protection Agency is proposing to add hazardous pharmaceutical wastes to the Universal Waste Rule to provide a system for disposing of hazardous pharmaceutical wastes.

The Synthetic Chemical Organic Manufacturers Association (SOCMA) has raised concerns over requirements for security vulnerability assessments (SVA) under the US Department of Homeland Security's (DHS) Chemical Facility Anti-Terrorism Act Standards (CFATS).

Industry experts are predicting that last week?s terror attacks in Mumbai, India may have at minimum some short-term effects on the pharmaceutical industry outsourcing business in that region.

The Federal Trade Commission (FTC) is seeking public comment on proposed revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising.

FDA's Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals" takes effect Monday, Dec. 8, 2008.

Reps. John D. Dingell (D-MI), current chairman of the Committee on Energy and Commerce in the US House and Representatives, and Bart Stupak (D-MI), chairman of that committee?s Oversight and Investigations Subcommittee, said that moving the Food and Drug Administration Globalization Act and other measures for drug and food safety will be a key priority for the next Congress.

The European Commission (EC) published a preliminary report stating that competition in the pharmaceutical industry does not work as well as it should.

A recent study shows life-science companies have difficulty in planning and executing change-management practices.

Asian countries are moving up the value chain for pharmaceutical outsourcing.

2009 will likely be a difficult period for emerging biopharmaceutical companies.

When accusations fly: 'Tis better to give than to receive.

The past year saw major acquisitions attempted, completed, rejected, and stalled.

Readers provide insight into the best companies to work for as well as the ups and downs of their jobs.

While the world pulls itself out from one of the worst crises in decades, Indian pharmaceutical companies are trying to capitalize on falling company prices by increasing their takeovers.

China's quality approach to domestic versus exported products seems to be a lose-lose situation.

A recent Pharmaceutical Technology survey examined the level, sources, and reasons behind innovation in drug development and manufacturing. This article contains bonus online-exclusive material.

A book about pharmaceutical analysis engages the reader with history and unexpected asides.

The next president and the 111th Congress might change the extent of FDA's authority.

Also, Johnson & Johnson will acquire Omrix Biopharmaceuticals for $438 million; Charles River Laboratories promoted Foster Jordan to corporate senior VP of endotoxin and microbial detection products; more...

Companies at the American Association of Pharmaceutical Scieintists (AAPS) unveiled technologies, expansion plans, and services for formulation development, manufacturing, and drug delivery at the AAPS Annual Meeting and Exposition held in Atlanta last week.

The American Association of Pharmaceutical Scientists (AAPS) recognized researchers in the pharmaceutical sciences at AAPS Annual Meeting and Exposition in Atlanta last week.

During its roundtable discussion titled "Follow-On Biologic (FOB) Drugs: Framework for Competition and Continued Innovation," The Federal Trade Commission (FTC) discussed likely effects, patent issues, and regulatory exclusivity periods concerning FOBs.

The US Food and Drug Administration issued a draft guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names, on Nov. 24, 2008.

In a letter to Acting Comptroller General Gene Dodaro dated November 19, 2008, Congressman Joe Barton (R-Texas) requested that the US Government Accountability Office (GAO) review the US Food and Drug Administration's handling of the highly-publicized, tainted heparin scare that occurred in 2007 and 2008.

Ranbaxy Laboratories (Gurgaon, Haryana, India) responded to an investigation of violations at two of its manufacturing plants, according to a Reuters Health report.