The US Food and Drug Administration released a final guidance on protocol for testing sterile products.

The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.

Last month, the European Human Embryonic Stem Cell Registry became operational. The organization hosted the 1st European Human Embryonic Stem Cell Registry Symposium to coincide with the launch of the program.

The US Food and Drug Administration recently revealed that the active ingredient used in the production of Baxter International Inc.'s recalled drug Heparin was made in a plant in China.

Also, Biocon will acquire 70% of AxiCorp, ARIAD Pharmaceuticals promoted Richard W. Pascoe to the new position of COO, more...

The US Food and Drug Administration issued a draft guidance for industry titled "Good Reprint Practices" regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

Preparing sterile products requires manufacturers to control microbial quality. Sterility and endotoxin content are critical because failure to properly manage them can seriously harm, or even kill, patients.

To ensure an effective treatment, a patient often must take equal doses of an active pharmaceutical ingredient (API) at regular intervals.

Featured products from this issue of Equipment & Processing Report

Scientists at The Wistar Institute are taking further steps into understanding a gene regulator that can lead them closer to developing new cancer therapies.

A follow-on biologics approval pathway may be on the way. US Health and Human Services Secretary Mike Leavitt accepted Sen. Charles Schumer's (D-NY) suggestion that the Food and Drug Administration and Congress work together to formulate legislation for such a pathway.

Chesapeake to relocate and expand, AVI BioPharma appoints CEO, More...

Nektar Therapeutics eliminated approximately 150 positions as part of a restructuring program designed to help the company complete its transition from a drug-delivery service provider to a drug-development organization.

Contract manufacturers of active pharmaceutical ingredients and intermediates unveil expansion plans and strategies at this year's Informex.

A recent business outlook survey conducted by the Synthetic Organic Chemical Manufacturers Association reveals a generally favorable view of current and future business conditions for contract manufacturing of active pharmaceutical ingredients and intermediates.

The US Food and Drug Administration is requesting a 5.7% increase in its budget between the current fiscal year, FY 2008, and FY 2009, for a total $2.4 billion budget.

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

Amgen will partner with R&D firm Takeda Pharmaceutical Company Ltd. toward the development and commercialization of 13 of Amgen?s molecules, with one included as an option.

The US Food and Drug Administration posted on its website a Jan. 24 Warning Letter to Novartis Vaccines and Diagnostics.

Brief pharmaceutical news items for February 2008.

A news roundup for February 2008.

The author suggests a route for nanotechnology's future in the pharmaceutical industry.

Can an overload of patent applications lead to the US' demise as a scientific leader?

An updated book summarizes recent research for formulators and drug-delivery specialists.

If at first the product fails, then inspect, inspect again

A wave of pharmaceutical expansions is expected in Europe this year, surprisingly by Indian companies.

Text sirtuins are the new kinases, according to a presentation given last month at the JP Healthcare Investors Conference in San Francisco by Sirtis CEO Christoph Westphal.

The US Food and Drug Administration has issued a not approvable letter to Merck & Co. in regards to their request for over-the-counter use of "Mevacor" (lovastatin) 20 mg.