
Much to the surprise of most close observers of the Food and Drug Administration, Janet Woodcock agreed last month to resume control of the Center for Drug Evaluation and Research.

Much to the surprise of most close observers of the Food and Drug Administration, Janet Woodcock agreed last month to resume control of the Center for Drug Evaluation and Research.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Eli Lilly terminated the development of its inhaled insulin product AIR, a diabetes treatment that had been in Phase III clinical trials.

ePT--the Electronic Newsletter of Pharmaceutical Technology
The 59th Pittsburgh Conference gathered more than 1000 exhibitors on its showroom floor this week.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Millipore plans to open Singapore facility, Michael J. Simms joins Alexza Pharmaceuticals, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
Merck & Co. advised AstraZeneca (London) that it will not exercise its option to sell its interest in certain AstraZeneca non-proton pump inhibitor (non-PPI) products this year.

ePT--the Electronic Newsletter of Pharmaceutical Technology
With another potential "made-in-China" crisis looming over the recall of heparin, critics and the media seem to be waiting in line to take another jab at the US Food and Drug Administration.

PTSM: Pharmaceutical Technology Sourcing and Management
Leveraging its global infrastructure, SAFC Supply Solution pilots a new external sourcing program.

PTSM: Pharmaceutical Technology Sourcing and Management
Draft federal legislation that would require high-risk chemical facilities to use inherently safer technology for reducing their risk may present potential problems for custom and batch manufacturers supplying the pharmaceutical industry.

After two centuries, there's no reason to maintain two tablet compression tooling standards.

A. Nair discusses patent disputes in India.

If not properly monitored, filters and plastic bags can keep back more than they should.

The United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.

New research and ideas for March 2008

SAFC is delivering on its plan for double-digit annual growth by increasing its businesses through organic growth and targeted technology acquisitions.

Show blasts off this month in Philadelphia with more suppliers, new trends, and real-world solutions.

A preview of some product enhancements and launches for Interphex 2008, the large trade show being held Mar. 26–28 in Philadelphia.

A news roundup for March 2008.

Brief pharmaceutical news items for March 2008.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Genmab will acquire PDL Pharma's Minnesota manufacturing facility, DSM Pharmaceuticals appointed Hans Engels president and business unit director, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Patent and Trademark Office rejected the patentability of claims of a patent by Genentech that related to certain methods used to make antibodies and antibody fragments by recombinant DNA.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Merck Capital Ventures, a subsidiary of Merck & Co., has invested $1.5 million to expand its service laboratory. The transaction with NanoImaging Services will add high-resolution, three-dimensional transmission electron microscope (TEM) capability, which allows biopharmaceutical researchers to see complex macromolecular structures they create with resolution as high as one nanometer.

ePT--the Electronic Newsletter of Pharmaceutical Technology
APP Pharmaceuticals will boost manufacturing of therapeutic multidose vials of heparin.

ePT--the Electronic Newsletter of Pharmaceutical Technology
The US Food and Drug Administration released a final guidance on protocol for testing sterile products.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

ePT--the Electronic Newsletter of Pharmaceutical Technology
Also, Biocon will acquire 70% of AxiCorp, ARIAD Pharmaceuticals promoted Richard W. Pascoe to the new position of COO, more...

ePT--the Electronic Newsletter of Pharmaceutical Technology
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.

Equipment and Processing Report
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.

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