News

The US Food and Drug Administration issued an alert to healthcare professionals of a change in heparin manufacturing that is expected to decrease the drug's potency.

Also, FDA partners with USDA on produce safety, and the Transparency Task Force announces its second public meeting...

The 2009 Nobel Prize in Physiology or Medicine was awarded to three US researchers for the discovery of how chromosomes are protected from degradation by telomeres and the enzyme telomerase during cell division.

GlaxoSmithKline (London), Novartis (Basel, Switzerland), sanofi Aventis (Paris), and Baxter International (Deerfield, IL) recently provided updates as to the development, manufacture, or shipment of pandemic (H1NI) vaccines.

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.

Company and People Notes: GSK forms joint venture with China-based Jiangsu Walvax Biotech; Sigma-Aldrich appoints VP and board member; more...

AAPS President offers hope and solutions for the industry's challenging future.

Almac's expansion plans in Northern Ireland (UK) could see the creation of more than 500 jobs during the next 5 years.

Contract research organizations such as Covance are heading further east through Europe.

The EMEA intends to fully implement its Product Information Management (PIM) approach, an initiative designed to improve information management, into the centralized procedure within 2 years, according to a statement of intent from the agency.

A review of NIPTE's core projects and its plans for training-and retraining-the pharmaceutical industry.

This article introduces the "Q.U.E.S.T." approach for vendor qualification, a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and hence make well-informed purchasing-related decisions.

As the pharmaceutical industry moves further into Central and Eastern Europe and the Commonwealth of Independent States, several standard-setting and regulatory bodies are also increasing collaboration in the region, particularly in Russia.

The author describes the framework needed to implement QbD and achieve the deeper process understanding that is fundamental to QbD.

This article is part of a Special Report on the Emerging Markets of The East, October 2009

The author analyzes, from an agency perspective, whether question-based review has improved product quality or made the review process easier for regulators or for industry.

How manufacturers can accelerate cashflow by cutting out the paper trail.

Also, FDA bans candy and fruit-flavored cigarettes, EMEA moves to improve information management.

A new report evaluating the biotechnology sector in new European Union member states and candidate countries has described biotech developments as "uneven" because of contrasting economic strategies in different countries.

The biopharmaceutical company Seattle Genetics (Bothell, WA) introduced a sugar-engineered antibody (SEA) technology that is designed to increase the potency of monoclonal antibodies through enhanced effector function.

The US Food and Drug Administration issued a proposed rule to clarify the current good manufacturing practice (CGMP) requirements applicable to combination products in the Sept. 23 Federal Register.

Company and People Notes: Boehringer Ingelheim will acquire Wyeth's animal health business; Amsterdam Molecular Therapeutics appoints CEO; more...

Rene Kummer of Sigpack Systems speaks about the company's new pharma toploader, which features an innovative box transportation unit.

On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria.

Abbott Laboratories (Abbott Park, IL) agreed to acquire the pharmaceutical business of the Solvay Group (Brussels, Belgium) for EUR 4.5 billion ($6.6 billion) in cash, according to an Abbott press release.

Vetter (Germany) is intending to open a technologically advanced customer services facility at the end of 2009 in Chicago (US).

The Gerresheimer Group is opening two new centres: an R&D center for medical plastic systems in the US and a new production center for pharmaceutical plastic packaging in Spain.

A joint venture between a charity and a pharma giant has led to the creation of the Hilleman Laboratories, which will use a not-for-profit operating model to develop and deliver vaccines to low-income countries.

The US Food and Drug Administration plans to hold a public hearing to discuss the promotion of agency-regulated drugs and medical devices on the Internet and using social media tools, according to a notice in the Sept. 21, 2009, Federal Register.

Also, FDA extended the deadline for the pilot program for the submission of CMC information.