Manufacturing

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

Genzyme has outlined why it believes sanofi-aventis's tender offer of $69 per share "dramatically undervalues the company" and why a price of $89 per share would be more reflective of the company's true value.

Puerto Rico's Governor Luis Fortuno unveiled a fiscal reform package in Puerto Rico this week as part of economic development and budget-deficit reduction plan for the commonwealth.

A European pilot initiative will test the impact of consultations with a number of stakeholders such as patient representatives and payers on early-stage drug development.

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.

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.

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.

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

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.

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.

The reopened debate over embryonic-stem-cell research could stifle many other scientific pursuits.

Private companies and universities are developing new ways to deliver protein drugs.

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

Global pharmaceutical companies could have a problem getting rid of redundant facilities.

Editors' picks of pharmaceutical science and technology innovations.

An expert-panel-written book has surprising shortcomings.

Drugmakers hatch new manufacturing paradigms in the wake of the 2009 H1N1 influenza pandemic.

From disagreement to denial, being cordial about quality control can be challenging.