News

Pfizer Forms Pact with Biocon; Baxter Makes Appointments; And More.

During Oct. 5-12, 2010, more than 40 countries cooperated in an international week of action to combat the online sale of counterfeit and illegal drugs and to raise awareness of their associated health risks.

Presentations Available from ICH Quality Workshops

The European Generic medicines Association (EGA) has made a number of recommendations on how to ensure the quality of medicines in the globalized supply chain; in particular, the EGA spoke about API quality and quality supervision, and how these can be improved by transparent communication between authorities and industry.

The US Food and Drug Administration has posted on its website the minutes of the PDUFA V reauthorizaton stakeholder meeting.

GlaxoSmithKline (GSK) has provided further details concerning its new unit dedicated to rare diseases, which was launched in February.

Jeffrey Hartry, director of quality systems and information at Cangene (Winnipeg, Canada), talks about his company?s conversion from a paper-based to an electronic training-management system.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the October 2010 edition from EMD Millipore and Sartorius.

An expert-panel-written book has surprising shortcomings.

Restructuring at sanofi-aventis will result in the elimination of approximately 1700 jobs in the US — about 25% of the company?s US Pharmaceutical Operations division workforce.

ICH Workshop Addresses Quality Systems.

sanofi to Cut 25% of US Workforce; AMRI Names VP of Chemical Development; And More.

The US Food and Drug Administration has released an implementation report on its Regulatory Science Initiative. The report outlines the agency's plans to advance regulatory science through new tools, standards, and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products, according to an agency press release.

The European Medicines Agency (EMA) has adopted new policies on access to documents and the handling of conflicts of interest

Following the low growth of the global pharmaceutical market in 2010, IMS Health's IMS Market Prognosis now expects the industry to rebound somewhat in 2011, growing at a rate of 5-7%, compared with only 4-5% in 2010, to reach $880 billion.

On Tuesday, Pfizer (New York) and King Pharmaceuticals (Bristol, TN), a specialty pharmaceutical-discovery and clinical-development company, entered into a definitive merger agreement under which Pfizer will acquire King for $3.6 billion in cash, or $14.25 per share.

An annual analysis rates the performance of pharmaceutical and biotechnology companies in corporate sustainability.

World leaders gathered at the United Nations last month to review the progress and map out a strategy for achieving the Millennium Development Goals.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

FDA to Hold Public Hearing on Biosimilars Legislation, And More.

On Monday, sanofi-aventis (Paris) began a hostile tender offer of $69 per share for all outstanding shares of Genzyme (Cambridge, MA).

The US Pharmacopeia released a statement this week that explains in more detail last January's recall of the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28).

Company and People Notes: Novartis Settles with US Attorney's Office; Hospira Names VP, And More.

A look at MVI's malaria work in developing countries.

The early part of the decade saw a decline in vaccine sales and manufacture, but finally the industry is bouncing back, with Europe particularly well placed to make an impact.

It?s been a busy few weeks at the European Medicines Agency (EMA), with a number of marketing authorization suspensions and safety reviews launched, including a thorough review of all bisphosphonate-containing medicines following a possible increased risk of atypical stress fractures.

Pharma companies must ensure that patients have access to "objective, unbiased information" about medicines, according to MEPs of the European Parliament?s Health Committee — this should be a patient right rather than an option for pharma companies.

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics.

Pfizer has discontinued a Phase III trial evaluating Sutent (sunitinib malate) in combination with prednisone for men with advanced castration-resistant prostate cancer following disappointing results.

The European Medicines Agency and the US Food and Drug Administration announced their individual regulatory decisions and resulting actions regarding the marketing of GlaxoSmithKline's (London) Avandia (rosiglitazone), a thiazolidinedione used to treat Type 2 diabetes.