Manufacturing

Following its $68-billion acquisition of Wyeth, Pfizer has unveiled detailed plans for its global R&D network, which includes consolidation of its R&D facilities.

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).

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.

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.

A smart nanocage that can be filled with a medicinal substance and then activated using light has been developed by US researchers.

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.

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.

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.

A panel of industry and regulatory experts, including FDA, discuss efforts to secure the global pharmaceutical supply chain. This article contains bonus online-exclusive material.

Contract organizations waiting for the pipeline to come roaring back are kidding themselves.

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."

The heightened focus on risk raises concerns about delays in approving new drugs.

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

Functionalized supramolecular catalysts and an enantioselective route to unnatural amino acids are some recent developments.

A recent book reminds readers that small-molecule chemistry has enabled advances in biotechnology.

The authors developed a robust, automated system to conduct Karl Fischer moisture assays for lyophilized products.

The authors explain a process for moisture-activated dry granulation in detail and provide guidance for the selection of excipients and equipment.