News

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.

A report from the European Medicines Agency (EMEA) has highlighted the critical fact that there are not enough new antibiotics in the pharmaceutical industry's pipeline to fight multidrug-resistant bacteria.

Many pharmaceutical companies in the United Kingdom are turning to basic business-skills training to help them emerge from the recession stronger than before.

Company and People Notes: Wyeth and Ambrx form development pact; Elite Pharma appoints CEO and CSO; more...

The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).

The current pharmaceutical model is in danger of becoming "irrelevant in the context of 21st century's global healthcare needs", according to a white paper published by global management consultancy firm A.T. Kearney.

AM Technology (UK) has joined an EU-funded project that seeks to develop flow processes for the industrial synthesis of pharmaceutical compounds.

The Senate Finance Committee through its chairman, Max Baucus (D-MT), introduced on Sept. 16, 2009, a bill, "America's Healthy Future Act of 2009," representing the latest Congressional proposal for healthcare reform.

Vaccine makers and other pharmaceutical manufacturers using yeast protein-expression systems are taking note of a discovery this week by a team of researchers who have found RNA interference in Saccharomyces castellii.

Also, FDA's enforcement of its rules for response times for Form 483s went into effect this week, more...

Eli Lilly and Company (Indianapolis, IN) is undergoing a companywide reorganization that is intended to accelerate the progress of the company's pipeline.

The US Food and Drug Administration has approved four vaccines for the H1N1 influenza virus, while other companies, including GlaxoSmithKline (GSK), have reported promising results from clinical studies with a single dose vaccine.

Speaking to the audience of the 2009 PDA-FDA Joint Regulatory Conference in Washington, DC, this week, US Food and Drug Administration Principal Deputy Commissioner outlined four principles that define FDA's role as a public health agency.

Company and People Notes: Sanofi Pasteur signs H1N1 vaccine deal with Brazilian government; Helsinn Group appoints CEO of US business; more...

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the September 2009 edition from Gore and Oystar.

Small-format packaging equipment can provide benefits to the pharmaceutical industry such as quick changeover and low tooling costs. The machines also can shorten the time it takes to bring a product to the market.

Investing time and money in auditing and optimizing a steam system can pay off quickly, especially because the costs of energy, maintenance, and downtime are steadily rising.

Encap Drug Delivery (UK) has licensed a coating technology that targets the release of drugs to the colon.

Pfizer will pay $2.3 billion to settle the investigation with the US Department of Justice regarding the off-label promotion of Bextra.