One more step closer to finalization, the ISA 100 Wireless Compliance Institute presented a live demonstration of a prototype of the ISA 1001.11a wireless standard-based products at the 2008 Wireless Conference in Chongquing, China.

US pharmaceutical and biotechnology research companies invested $58.8 billion in research and development in 2007, according to analyses by the Pharmaceutical Research and Manufacturers of America and Burrill & Company.

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

Filing risk and mitigation strategies is now a requirement for manufacturers of new drugs and biologics.

The former formulation-development business of MDS Pharma Services seeks to build its niche in early-phase drug development.

A reference book omits important information and ignores advanced testing procedures.

Essential components of a good inspection: good ingredients, proper inserts, and ... deer?

A changing regulatory environment is on the horizon for excipient suppliers and users.

Financial experts share their insights for the performance for innovator drug companies and generic-drug players.

The FDA itself issues a cry for help. Is anybody listening?

Excipient producers and industry observers share their perspectives on innovation for excipients.

Antibodies are highly specific molecules that can be tailored to recognize almost any stretch of peptide that nature can conjure: a feature that has been exploited for years now to produce therapeutic antibodies.

Sophisticated replication techniques have made counterfeiting and fraud a serious threat to the pharmaceutical industry.

Was FDA's decision to issue a draft guidance on of-label information, amidst Congressional scrutiny, the right thing to do?

Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. This Part 1 article explains the value of performing prerequisite verifications and presents case-study examples and real-world solutions to avoid costly process validation failures.

What makes a drug ripe for respiratory delivery?

It is the end of an era. Building on more than 6 years of dedication and hard work, Gurminder Marwaha has left Pharmaceutical Technology Europe (PTE) in search of new challenges. As his successor, I would like to join all the members of the editorial team in wishing him every success.

US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics.

In a press release, the University of Texas announced that Mauro Ferrari, of the University?s Health Science Center at Houston, presented a proof-of-concept study of a new multistage delivery system for imaging and therapeutic applications.

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

Scientists at the University of North Carolina at Chapel Hill have successfully tested a new inhaled tuberculosis (TB) vaccine.

The US market for prescription pharmaceutical grow only 3.8% in 2007, the lowest growth rate in more than 40 years, according to a recent analysis by IMS Health.

Sandoz introduced its "Omnitrope Pen 5" with liquid cartridge in the United States. The product was approved by the US Food and Drug Administration and is a new form of the first follow-on version of a recombinant biotechnology drug.

The US Pharmacopeial Convention announced a revised glycerin monograph in the United States Pharmacopeia.

As part of ongoing efforts to improve the quality of imported drug products, the US Food and Drug Administration is setting up shop in China.

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

The US Senate passed an amendment to the fiscal year 2009 budget bill that will increase the amount allotted to FDA by $71 million, bringing the agency's total FY 2009 budget increase to $375 million.

Hoping to provide a better understanding of its role in the heparin contamination investigations, the US Food and Drug Administration has posted a series of information sheets on its website.