Manufacturing

The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.

Company and People Notes: SurModics forms agreement with Roche and Genentech; Hospira names Daphne Jones senior VP and chief information officer; more...

Following the completion of its $68-billion acquisition of Wyeth (Madison, NJ), Pfizer (New York) began joint operations of the combined company last week.

The European Fine Chemicals Group (EFCG) gave an update of some of its activities at a press conference held at CPhI Worldwide (Spain) last week, and revealed some disturbing facts regarding counterfeit APIs, which the group is particularly concerned about.

The manufacturing process, which influences a drug's safety and efficacy, is particularly critical for drugs administered through injection, and personnel must closely supervise lyophilization to ensure product quality.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the October 2009 edition from Emerson and Minitab.

Economic pressures are forcing pharmaceutical manufacturers to look for ways to become more competitive. Many companies realize that they must reduce operating costs but maintain or improve product quality.

For the first time, cancer treatments accounted for 5% of overall drug spending in the first half of 2009, said Medco Health Solutions in a press release last week.

Company and People Notes: Bayer Schering Pharma forms collaboration with Compugen; Takeda San Francisco appoints VP of process science; more...

IMS Health delivered some good news last week with its updated pharmaceutical market forecast.

GlaxoSmithKline (GSK), Novartis, sanofi aventis and Baxter International have provided updates regarding the development, manufacture and shipment of pandemic (H1NI) vaccines.

A new drug delivery method developed by scientists could enable prescription drugs to be buried inside the body where drug release could be prompted by a biological trigger, such as a drop in blood sugar levels, or activated manually with a pulse of light.

A long-term joint venture between GlaxoSmithKline (GSK) and China's Jiangsu Walvax Biotech Company hopes to develop and manufacture paediatric vaccines for use in China.

Thomas LaVake, manager, worldwide environment, health & safety at Johnson & Johnson, provides a perspective on sustainability practices for the pharmaceutical industry.

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.

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.

Pharmaceutical companies in India have had a hold on the biotechnology sector for many years, and they're not about to let the follow-on biologics market pass them by.

The countries of Central and Eastern Europe and the Commonwealth of Independent States are closing in on global pharmaceutical competition.

Strict enforcement, new rules, and organizational changes signal an activist tone.

Industry, equipment vendors, and regulators are busy refining the precision and reliability of dissolution testing.

BIO supports recent Congressional action toward a 12-year data exclusivity period for innovators.

The nation's healtcare system needs an overhaul, but it has to be done right.