News

Last week, GlaxoSmithKline (GSK, London) agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

Around half of all multiple sclerosis (MS) patients that are eligible for treatment do not receive it and one in five of those patients that do begin therapy, delay doing so because of fear and anxiety over the treatment process, and not fear and anxiety about the disease.

Following the its $68-billion acquisition of Wyeth (Madison, NJ), Pfizer (New York) Pfizer detailed plans for its global research and development (R&D) network, which includes consolidation of its R&D facilities.

The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance.

FDA has approved a fifth influenza A (H1N1) vaccine, manufactured by ID Biomedical.

Company and People Notes: Genzyme provides updates on enzyme replacement products and FDA complete response letter; Watson appoints VP of global operations; more...

Pigging is a sustainable strategy that can aid in cleaning and product recovery and improve a manufacturing line's efficiency and throughput.

Recent advances in microreactor technology are improving the application and scale at which the technology can be applied.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the November 2009 edition from Enercon and Schreiner.

Company and People Notes: 3M forms agreement with VaxInnate; TRIN Pharma appoints CEO; More...

A consortium led by GlaxoSmithKline (UK) intends to deliver a "step change improvement" in pharmaceutical tablet manufacturing in the UK by "substantially" increasing the country's manufacturing efficiency.

On Sunday, Nov. 8, 2009, the Pharmaceutical Research and Manufacturers of America (PhRMA) expressed its disappointment with the US House of Representatives's healthcare-reform bill.

The American Association of Pharmaceutical Scientists (AAPS) recognized researchers at the organization's 2009 Annual Meeting and Exposition in Los Angeles this week.

Novartis reported that German regulatory authorities approved its adjuvanted cell culture-based Influenza A (H1N1) 2009 monovalent vaccine, Celtura. The company also said it will acquire a stake in Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical.

The European Medicines Agency, the European Center for Disease Prevention and Control, and the Heads of Medicines Agencies issued a European strategy for H1N1 vaccine benefit–risk monitoring.

Also, Commissioner Hamburg addresses the nation's doctors in a letter about the influzenza A (H1N1) virus and vaccine.

A new pharmaceutical company with a focus on rare diseases has been formed in Sweden following the merger of the Swedish companies Biovitrum and Swedish Orphan.

Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported last week that the US Food and Drug Administration responded to the association's citizen petition relating to the inspection process of foreign drug-manufacturing facilities.

Lonza (Basel, Switzerland), the large contract manufacturer of small-molecule and biologic-based active pharmaceutical ingredients (APIs), announced last week a series of cost-cutting measures for the next 12 to 18 months.

The European Organization for Rare Diseases (EURORDIS) predicts that 100 new designated orphan products will receive marketing authorization between 2009 and 2019, which equates to approximately 10 new products every year.

In response to a request from the US Food and Drug Administration, the US Pharmacopeial Convention (USP) revised its standards for propylene glycol and sorbitol solution

Company and People Notes: sanofi aventis forms pact with Micromet; Laureate Pharma adds members to its business team.

Novartis (Basel, Switzerland) plans to invest $1 billion over the next five years to increase research and development activities in China, including a significant expansion of The Novartis Institute of BioMedical Research (CNIBR) in Shanghai.

Last week, the steering committee and expert working groups of the International Conference on Harmonization (ICH) met in St. Louis, Missouri. A major success of the meeting was the adoption of several annexes to ICH Q4B on pharmacopeial texts.

New tests solve one issue, but cheaper plastic and new stoppers cause problems.

The author explores differences between two qualification documents, the draft guidance from FDA "Process Validation: General Principles and Practice" and the ASTM E2500-7 standard "Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment."

With a five-yar revision cycle around the corner, USP will hit or miss the collaboration mark.

While Congress debates hundreds of healthcare plan proposals, perhaps we, the public, can get in the game too.

New standards may overlook critical qualification needs.