Pharmaceutical Technology Editors

After a one-year delay in its implementation, the US Pharmacopeia Chapter 467 "Residual Solvents" is now official.

The Congressional Budget Office has released a report that provides a picture of the financial impact from the enaction of S.1695, the Biologics Price Competition and Innovation Act of 2007.

President Bush signed H.R. 2642, the Supplemental Appropriations Act of 2008, which provides $150 million to the US Food and Drug Administration for medical-safety and drug-safety activities.

The US Pharmacopeia (USP) posted revised monographs for heparin sodium and heparin calcium on its website.

Biomedical researchers at UT Southwestern Medical Center and nanotechnology scientists at UT Dallas are collaborating on a study that seeks to selectively kill cancer cells using monoclonal antibodies to coat carbon nanotubes that heat up when exposed to near-infrared (NIR) light.

Also, Stiefel Laboratories will acquire Barrier Therapeutics, Danube Pharmaceuticals appoints Brian Levy COO, more...

A review of an event that gathered in Cork (Ireland) the crème-de-la-crème in the world of excipient technology.

Also, Patheon to expand Puerto Rico facility, Creabilis Therapeutics appoints Tony Wilson CEO, more...

Effective July 1, 2008, the Office of Generic Drugs (OGD) will require abbreviated new drug applications (ANDAs) to include data that demonstrate the manufacturer's control of residual solvents.

The US Food and Drug Administration and the European Medicines Agency will collaborate in efforts that would allow drug companies to submit results of seven new drug-safety tests.

To choose the appropriate conveying system, a pharmaceutical manufacturer needs a thorough knowledge of the benefits and limitations of each conveyor type. The following overview compares several types of systems.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the June 2008 edition: Esco Technologies and Hawk Measurement

Manufacturers have stopped seeing disposable containment as an ad hoc solution, and the technology increasingly incorporates thoughtful design and engineering. The future promises to bring more changes and new applications for disposable containment technology.

In an assessment report about medicinal products containing heparin, the European Medicines Agency (EMEA)'s Committee for Medicinal Products for Human Use (CHMP) said it could not draw firm conclusions about the level of risk associated with unfractionated heparins (UFH) contaminated with oversulfated chondroitin sulfate (OSCS). Nevertheless, CHMP recommended that contaminated lots be withdrawn completely.

Also, Shire voluntarily recalls ADHD patch Daytrana

Also, Pall plans expansion in South America, Anthony Clarke joins Alexza Pharmaceuticals, more...

The transatlantic cooperation of the European Commission, the European Medicines Agency, and the US Food and Drug Administration was recognized at the Second Meeting of the Transatlantic Economic Council, held mid May in Brussels. The TEC is tasked with overseeing and accelerating government-to-government cooperation to advance economic integration between the United States and the European Union.

The US Food and Drug Administration advised patients, caregivers, and healthcare professionals to switch to hydrofluoroalkane-propelled albuterol inhalers now because chlorofluorocarbon-propelled inhalers will not be available in the US after Dec. 31, 2008.

Brief pharmaceutical news items for June 2008.

University of Calgary biochemists used computer simulation in a new toxicity study to predict how "buckyballs," carbon-60 soccer ball-shaped nanomolecules, could damage animal cells.

Also, GVK BIO and Wyeth Pharmaceuticals form research agreement, Eli Lilly announces changes to management, more...

In a white paper published today, the US Food and Drug Administration described its Sentinel Initiative to create an electronic safety system that tracks drug performance.

Cambridge Consultants is developing a low-cost portable instrument to test respiratory drug-delivery devices.

The Committee on Oversight and Government Reform held a hearing on whether the US Food and Drug Administration's drug and medical device regulation bar state liability claims.

Also, Pfizer to close Indiana "Exubera" facility, executive appointments at Patheon, more...

PharmTech's monthly newsletter, reviews the Editor's Picks for the May 2008 edition: Watson-Marlow Flexicon and HealthStar

Controlling modular, self-contained process skids (known as plug-and-play components) with an automation system can increase a pharmaceutical manufacturing facility?s flexibility.

Manufacturers in the life sciences are increasingly implementing wireless technologies to reduce the overall cost of compliance.

Also, Quintiles Transnational to acquire Eidetics, ChemAxon appoints Alex Drijver CEO, more...

Researchers at the University of Southern California's Information Sciences Institute (ISI) demonstrated a way to manufacture miniscule containers called voxels that could potentially deliver precise microdoses or even nanodoses of drugs.