News

A new automated factory in Boston (MA, USA) has been developed that uses non-genetically modified green plants to quickly produce large quantities of vaccines and therapeutics.

The European Medicines Agency published a summary report that includes suggestions for improving the current processes for evaluating benefit-risk.

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Charles River Acquires WuXi AppTec; Amgen Appoints President and COO; and More.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

FDA Issues Warning Letter To Pfizer; And More.

The US Pharmacopeial Convention recently held its convention in Washington, DC.

AstraZeneca has finalized its agreement with US federal and state entities, under which it will pay $520 million to resolve allegations that it marketed the anti-psychotic drug Seroquel for off-label uses.

An evaluation conducted by Ernst & Young assessing the effectiveness and efficiency of the European Medicines Agency has largely praised the agency; however, a number of strategic and operational recommendations for further improvements have also been made.

Despite pharma's upcoming peak years of patent expiries and the threat of generic competition, growth during the next 5 years is expected to be strong with the global market for pharmaceuticals forecast to reach more than $1 trillion by 2014, according to IMS Health.

The Society of Chemical Manufacturers and Affiliates is raising concerns over a recently introduced bill in the US Senate, which seeks to reform the Toxic Substances Control Act.

INTERPHEX 2010 will take place this week at the Jacob K. Javits Center in New York.

After several years of debate and review, the US Food and Drug Administration is calling for the removal of metered-dose inhalers.

FDA Issues Warning Letters to Astellas, GSK, And Novartis; Sandoz Acquires Oriel Therapeutics; And More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the April 2010 edition from Camfil Farr and K-Tron.

The green movement promises to make life-sciences manufacturing processes more environmentally friendly.

If you’ve worked in the drug industry for a while, chances are good that you remember Pfizer’s Rezulin, which was produced through hot melt extrusion (HME). If you work for a major pharmaceutical manufacturer, it’s likely that your company owns a twin-screw extruder. Yet HME has not been a common way of manufacturing drugs, and many industry employees don’t understand the principles of HME or the advantages that the technique offers.

Orphan drugs may help pharma companies to reduce the impact of revenue loss caused by patent expiries of blockbuster drugs, according to market analysts Frost & Sullivan.

Regenerative medicine has been described as holding the "promise of cures" by speakers at the first annual Translational Regenerative Medicine Forum, which was held last week in the US.

The US Pharmacopeial Convention will hold its governance meeting next week in Washington, DC.

FDA Issues Warning Letters to Six US Medical Spas; and More.

Cephalon Completes Acquisition of Mepha; Xcellerex Appoints President and CEO; and More.

The US Food and Drug Administration held a public meeting in Rockville, Maryland, on April 12, 2010, to solicit stakeholders' comments about the Prescription Drug User Fee Act program.

Orphan drugs may help pharmaceutical companies reduce the effect of revenue loss caused by patent expirations of blockbuster drugs, according to Frost and Sullivan.

sanofi-aventis outlined an investment plan for adapting its chemical and biotechnology manufacturing facilities in France during the next four years.

FDA Approves New Formulation For OxyContin To Discourage Misuse And Abuse.

The US Pharmacopeial Convention welcomed Minghao Zhou of China's Zhejiang Provincial Institute for Food and Drug Control.

Eli Lily Wins Court Battle; Genzyme Appoints COO; And More.

New information improves an organization's guide to building manufacturing facilities.

The US Government Accountability Office issued a report that's largely critical of FDA's efforts to fully use practices for effective strategic planning and management.