News

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.

The Synthetic Organic Chemical Manufacturers Association is evaluating proposed legislation, The Climate Security Act of 2008 (S. 3036), which directs the Environmental Protection Agency to establish a program for decreasing greenhouse emissions.

The global and US biotechnology industries performed well in 2007 as each recorded higher revenues and inched toward aggregate profitability.

As part of a larger effort to address drug counterfeiting, the European Commission is seeking to tighten manufacturing and related supply-chain requirements for active pharmaceutical ingredients.

Customers complaining lead to some serious explaining.

Brief pharmaceutical news items for June 2008.

Risk management, and its benefits for patients, plays a big role at the PDA Annual Meeting.

New products for sterile filling, quality control, and anticounterfeiting measures gained notice.

With rising drug deveopment costs and burdensome clinical trials, Indian-based firms are transferring their research departments to other entities in hopes of saving cash, mitigating risk, and ultimately, buying back the rewards.

The authors focus on how single-use systems effectively control three potential sources of common contamination: cross contamination, microbial contamination and biologic contamination of the process facility.

Letting the public inside the drug development process may increase their faith in what we do.

Although the spotlight is now on nanoparticulate delivery for biologicals, other strategies have proven successful.

The good, the bad, and the ugly about direct-to-consumer advertising.

Scientists are uncovering signaling systems that operate via cannabinoid messenger molecules.

An ambitious survey of characterization techniques presents current information.

On 7–9 May I attended ERBI's Biopartnering Exchange in Cambridge (UK), an event that brought together national and international entrepreneurs, senior executives and industry experts of the biotechnology sector.

Ranjit Barshikar, GMP/Quality Consultant and former Vice President of Global Quality for Ranbaxy Laboratories analyses the past, present and future of Asia's pharmaceutical industry. Read more...

Last week, 2704 delegates representing 190 nations met in Geneva for the 61st World Health Assembly to set a global course for tackling new as well as longstanding threats to public health worldwide. The assembly?s biggest breakthrough focused on adopting a resolution that encourages research and development (R&D) as well as access to medicines for people living in developing countries, according to a World Health Organization (WHO) release.

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.

The US Senate approved a measure (HR 2642) that would provide the US Food and Drug Administration with $275 million in additional funding under a supplemental appropriations bill. The measure now goes before the House.

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.

The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade association representing European pharmaceutical manufacturers, issued recommendations to the public consultation launched in March by the European Commission's proposed drug anticounterfeiting measures. EFPIA's proposal includes a ban on drug repackaging.

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

The World Health Organization's World Health Assembly is holding its 61st annual session this week to discuss a number of public health issues, many of which are tied directly to pharmaceutical manufacturing.

The devastating May 12 earthquake that struck the Wen Chuan Sichuan province of China left tens of thousands dead, homes and businesses destroyed, and survivors without basic human needs such as shelter, food, and medicines. The quake also had a significant impact on the local industries of the region. Pharmaceutical companies located within the affected areas are assessing possible damage to facilities and loss of personnel.

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.