Manufacturing

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 California Senate passed SB 1096 on May 29, voting to amend the state?s Confidentiality of Medical Information Act to allow pharmacies to provide third parties with patient information for the purpose of mailing prescription refill reminders and drug information directly to patients.

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.

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.

Comparative-effectiveness analysis aims to promote appropriate pharmaceutical spending.

Customers complaining lead to some serious explaining.

Brief pharmaceutical news items for June 2008.

The author provides an overview of key regulatory issues facing companies seeking to market their biopharmaceutical agents globally.

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

Creating a kinder, gentler manufacturing process that doesn't kill the product is the goal of process developers doing large-scale cell culture for cell therapy.

Editors' Picks of Pharmaceutical Science & Technology Innovations

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

Nanoparticle-based systems present many advantages for the delivery of current and emerging biological drugs.

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.

Our oral pharmaceutical product is packaged by a range of contract packaging companies. Adverse properties of the final packaged product from one particular company indicate that the product shelf life is shorter than it should be. It has been suggested that this could be related to gas filling issues. Is this anything that surface analysis could clarify?

Drug products subjected to degradation because of environmental stresses can be salvaged if proper packaging and protection is provided by sorbents.

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 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.