Industry News

Preliminary results from a clinical trial of Sanofi Pasteur's (Lyon, France, www.sanofi.com) H5N1 prepandemic influenza vaccine indicate the vaccine is safe and was well-tolerated in 300 healthy volunteers. This study is the first trial of an H5N1 prepandemic influenza vaccine candidate that compared vaccines with and without adjuvants.

The European Science Foundation (ESF) has published the conclusions of its 2-year Forward Look Study on Nanomedicine. Defined as a billionth of a metre, a nanometer is 1000 times smaller than the width of a human hair. Nanomedicine uses nanoscale technology to diagnose and treat disease. The scope of the study included defining the field of nanomedicine, reviewing what has been achieved so far, determining Europe's strengths and weaknesses, and drawing up plans to ensure continued growth.

Small- and medium-sized enterprises (SMEs) will gain administrative and procedural assistance from the EMEA. The agency's SME office was launched in December 2005 and follows the new Commission Regulation, which aims to promote the development of medicinal products in SMEs.

Recent EU legislation change has opened the door for UK firm Accentus to use its novel predictive crystallization technology to discover and develop generic alternatives to patented drugs. Accentus will also licence its CrystalGEM predictive crystallization technology to generics manufacturers.

Pharmaceutical industry regulation is about to change with a new code of practice. This has been revealed by the Association of the British Pharmaceutical Industry (ABPI) following recent problems with patient safety and the dissemination of data and information of approved drugs, which exposed loopholes within the code.

Merck (Whitehouse Station, NJ, www.merck.com) has revealed the "first phase" of its global restructuring program set to eliminate 7000 jobs (11% of its global workforce) by the end of 2008, close or sell 5 of its 31 manufacturing facilities, and roll out a manufacturing strategy to "drive significant efficiencies, decrease headcount, and reduce or refocus operations throughout the plant network and the entire manufacturing division." The company also expects to close one basic research site and two preclinical development sites.

Roche (Basel, Switzerland, www.roche.com) has put a temporary halt on the distribution of the antiviral treatment, "Tamiflu" (oseltamivir phosphate), a neuraminidase inhibitor, to the United States in an effort to deter companies from stockpiling the antiviral for employee use, according to an article in the Oct. 27 edition of The New York Times.

The introduction of new measures on advertising and promotional materials for prescription medicines could delay UK launches. The Medicines and Healthcare products Regulatory Agency (MHRA) has admitted that the checks, which have been introduced in response to a Commons' Health Select Committee report, could extend a launch by at least 2 weeks.

The monopoly held by the large pharmaceutical companies within drug discovery could be falling into the hands of biotechnology firms claims Frost and Sullivan. The consultancy company's report, Biochips Technology Redefines Process of Drug Discovery, states that biochip manufacturers are encouraging end users to accept the new technology by providing novel and effective solutions.

Moheb Nasr, PhD, director of the newly created Office of New Drug Quality Assessment at the US Food and Drug Administration (Rockville, MD, www.fda.gov), has proposed creating a "regulatory agreement" between FDA and sponsors to govern the chemistry, manufacturing, and controls (CMC) sections of new drug applications (NDAs).

A range of insect exterminator equipment has been developed to improve the level of hygiene offered to the pharmaceutical and chemical manufacturing sectors. Berson's Insectron range uses ultraviolet (UV-A) and green light to attract flying insects, which are sensitive to these light sources.

Lester Crawford, FDA's top man, has resigned explaining that it was time to step down — despite only being promoted to commissioner earlier this year.

The US Food and Drug Administration (Rockville, MD, www.fda.gov) released a new draft guidance that may speed generic approvals. The guidance, ANDAs: Impurities in Drug Products, describes the degradation-product information that generic drug manufacturers should include in their abbreviated new drug applications (ANDAs). This clarification, FDA officials say, will help companies submit the correct information, thus increasing the likelihood that their generic drugs will be approved, and approved more quickly.

Adding Braille to pharmaceutical packaging should be less of a challenge with the use of Esko-Graphics' Scope solution. EC Directive 2004/27/CE requires Braille labelling and information to be provided with pharmaceutical products for human use, and companies are scrambling to implement this by 31 October.

The US National Institute of Allergy and Infectious Diseases (NIAID, Bethesda, MD, www3.niaid.nih.gov) announced it will order two million doses of an avian influenza vaccine from Sanofi-Pasteur (Swiftwater, PA and Lyon, France, www. sanofipasteur.com). In April, the NIAID began a Phase I trial to evaluate the vaccine’s safety and ability to generate immunity against the H5N1 strain of avian flu, an illness that leads to severe disease and possible death in birds and humans.

Manufacturers of pharmaceuticals and nutraceuticals can protect their products from moisture and other elements while also enhancing marketability, by adding scent to their packaging. The full line of scented packaging solutions, offered by Süd-chemie, is reported to be ideal for applications that emit an unappealing odour to end users. The packaging can also enhance the marketability of odourless products. The flagship product in the scented solution line is Aroma-Can — a product modelled after the company's desiccant canisters. One-gram canisters will be available in orange and lemon scented variations, and can be inserted at the same high rates of speed as traditional desiccant canisters using standard canister insertion equipment.

Chiron Corporation (Emeryville, CA, www.chiron.com) announced that quality problems at its Marlburg, Germany, manufacturing plant will prevent the company from supplying its "Begrivac" influenza virus vaccine to non-US markets for the 2005–2006 flu season.

To help meet the needs of the fast-growing, global biopharmaceuticals industry, Pall Corporation has launched five innovative technologies aimed at increasing drug-manufacturing efficiency through customization and disposability. The Mustang XT5000 capsule is the company's novel chromatography technology for efficient capture of large molecules, especially used to develop DNA and virus-based drugs. Expanding its portfolio of technologies for disposable processing, Pall offers both the customizable Tangential Flow Filtration system, which incorporates single-use components for downstream processing applications, and the Kleenpak Connector — a new single-use device, which enables aseptic connections to be made instantly.

Able Laboratories, Inc. (Cranbury, NJ, www.ablelabs.com) announced in late May that it would halt all production and recall all available product because of problematic testing procedures discovered during an internal investigation. The company manufactures mostly generic prescription drugs, including drugs containing acetaminophen.

Pharmaceutical science and technology news.

Regulation: FDA Steps Up Action Against Counterfeit Drugs, Warns US Consumers Against Fake Medicine from Mexico

Pharmaceutical science and technology news.

Pharmaceutical Science and Technology News

pharmaceutical science and technology news

Pharmaceutical Science & Technology News

Pharmaceutical Science & Technology News

Pharmaceutical Science & Technology News

Pharmaceutical Science & Technology News

Pharmaceutical science and technology news

Pharmaceutical Science & Technology News