News

The US Food and Drug Administration’s $1.95-billion budget request for the 2007 fiscal increases spending on high-priority programs by $70 million, and cuts support for some existing programs by $52 million.

Akzo Nobel NV (Arnhem, the Netherlands, www.akzonobel.com) plans to spin off its pharmaceutical division by creating a separate company, Organon Biosciences.

Merck wins approval for rotavirus vaccine as Sanofi ships investigational H5N1 vaccine to NIH and CDC explores new flue diagnostics and novel vaccine-production technology.

ASTM International’s (West Conshohocken, PA, www.astm.org) Committee E55 on Pharmaceutical Application of Process Analytical Technology has established a subcommittee “E55.03 on General Pharmaceutical Standards,” to focus on issues relating to quality within a chemistry, manufacturing, and control framework.

Cambrex Corporation (East Rutherford, NJ, www.cambrex.com), a contract manufacturer and provider of life sciences products and services, has retained Bear Sterns & Co Inc. as an advisor as it considers strategic alternatives for the company.

Dow AgroSciences Receives Regulatory Approval for Plant-Made Vaccine

Albany Molecular Research To Acquire ComGenex

FDA is opening the door to continuous learning in process development.

"It was the late 1970s," reports our GMP-Agent-in-Place, "and we used a primitive desktop computer with built-in teletype for our quality control work.

I rarely talk science on the weekends. I spend a good deal of that free time with friends from college performance groups. The conversation centers more on choreography and piano concerti than on CGMPs and chemical reactions. So it always throws me for a loop when these theater and music buffs drop pharmaceutical news into casual conversation.

Lonza Plans Biologics Manufacturing Expansion

This is a year of change for the Synthetic Organic Chemical Manufacturers Association (SOCMA), the Washington, DC-based trade association representing chemical batch and custom manufacturers. Following the sale of Informex, its flagship trade show, last fall, the association is advancing key programs, most notably its new ChemStewards program, an environmental, health, safety, and security initiative (EHS&S) that its members began implementing last month.

Enterprise information integration delivers needed real-time capability to operational business intelligence.

SAFC Launches SAFC Supply Solutions

Eggs from Transgenic Hens Express Interferon Beta-1a Protein

Preliminary results from a clinical trial of Sanofi Pasteur's (Lyon, France, www.sanofi.com) H5N1 prepandemic influenza vaccine indicate the vaccine is safe and was well-tolerated in 300 healthy volunteers. This study is the first trial of an H5N1 prepandemic influenza vaccine candidate that compared vaccines with and without adjuvants.

Cell-Grown Vaccine Protects Against Avian Flu Virus

Non-Injectable Insulins Win Approval: Pfizer in the US, Generex in South America

If delaying the project has little consequence then you should probably not run the project in the first place.

It's all well and good providing drugs for people who need them, but it becomes a lot more difficult if they choose to ignore the warnings

The European Science Foundation (ESF) has published the conclusions of its 2-year Forward Look Study on Nanomedicine. Defined as a billionth of a metre, a nanometer is 1000 times smaller than the width of a human hair. Nanomedicine uses nanoscale technology to diagnose and treat disease. The scope of the study included defining the field of nanomedicine, reviewing what has been achieved so far, determining Europe's strengths and weaknesses, and drawing up plans to ensure continued growth.

Small- and medium-sized enterprises (SMEs) will gain administrative and procedural assistance from the EMEA. The agency's SME office was launched in December 2005 and follows the new Commission Regulation, which aims to promote the development of medicinal products in SMEs.

FDA Unveils New Prescription Drug Information Format

AAIPharma Moves Ahead with Reorganization Plan

FDA Eases Phase I Manufacturing Requirements

Warning: Brazilian Diet Pills Found to Contain Active Drug Ingredients

Pfizer Combats Counterfeiters with RFID

FDA Issues Dispute–Resolution Guidance

Novartis Considers Acquiring Berna Biotech

Schering-Plough Meets FDA Deadline for CGMP Improvements