News

The Society of Chemical Manufacturers and Affiliates (SOCMA) reported in late July that Eurostat, the Statistical Office of the European Communities, recently published a baseline study or the first snapshot of REACH policy in the preregistration phase.

The US Food and Drug Administration announced its prescription drug user fee rates for fiscal year 2010 in the August 3 Federal Register.

Also, Pfizer forms two research agreements in China; NanoInk appoints John Kubricky to its scientific advisory board; more...

The Energy and Commerce Committee of the US House of Representatives approved H.R. 3200, America's Affordable Health Choices Act, last Friday.

The US Food and Drug Administration and European Medicines Agency (EMEA) launched this week a joint initiative to collaborate on international good clinical practice (GCP) inspection activities.

Novartis has confirmed that the ashes of CEO Daniel Vasella's mother have been stolen and his holiday home set fire to.

South Africa was the first country on the African continent to become a PIC/S member. The country's Director of Inspectorate and Law Enforcement describes the 10-year process.

Big Pharma entered biotech too late. That same mistake can be avoided in personalized medicine.

The author of an ambitious book about quality control falls short of reaching his goals.

The author of a book about biopharmaceutical production includes irrelevant information.

Individuals and companies at the top seem to have no problem short-circuiting their success.

Determined to prevent further supply-chain breaches, industry takes charge, offers proposals.

An ounce of contamination usually leads to a mountain of investigation.

A Q&A with Pfizer CentreSource, moderated by Jim Miller.

The authors explain waivers and deferrals for pediatric studies of drugs and biologics as provided by the Pediatric Research Equity Act of 2007.

A summary of recent changes to European regulatory requirements for pediatric formulations.

On July 18 in Mumbai, Hillary Rodham Clinton's private, cosy tete-a-tete with 10 of India Inc's most sought-after billionaires, was a power breakfast the likes of which the city's corporate czars had not seen in a long time.

Researchers working on extending the shelf life of antibody drugs may find help in a computer model developed by a research team at MIT (Cambridge, MA).

This week, Sanofi Pasteur, the vaccines division of sanofi aventis (Paris), acquired the ShanH subsidiary of Mérieux Alliance, a holding company.

The number of alliances between diagnostics companies and pharmaceutical companies is set to rise because of the growth of personalized medicine, according to a report from PricewaterhouseCoopers.

In a move to strengthen development of its biologics portfolio, Bristol-Myers Squibb (BMS, New York) has agreed to acquire the biopharmaceutical company Medarex (Princeton, NJ) for $16 per share or approximately $2.4 billion.

Also, Isogen completes sterile facility; Dishman appoints head of generic API business; FDA releases final rule on authorized generic drugs and NDA submissions; more...

The United Kingdom's pharmaceutical sector sector will soon have its own organizational body to help employers drive the key skills agenda of the industry.

China's State Food and Drug Administration has completed a new draft of GMP guidelines, but after a series of quality-control events, it will take time for the country to regain the global pharmaceutical industry's trust.

Last week, Rep. George Miller (D-CA), Rep. Charles Rangel (D-NY), and Rep. Henry Waxman (D-CA), introduced the America's Affordable Health Choices Act (H.R. 3200) to reform the nation's healthcare system.

A new report from the European Commission show a significant increase in the amount of intellectual property rights (IPR) infringements between 2007 and 2008, including a 57% increase in the number of counterfeit medicine cases between the two years.

The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances.

Two years ago, the US Food and Drug Administration's Office of Generic Drugs (OGD) developed and implemented a program to test question-based reviews for abbreviated new drug applications (ANDAs). OGD is reviewing the benefits and challenges faced by pharmaceutical firms involved in the initiative to see what changes need to be made going forward.

Also, Gilead and Tibotec form agreement; FDA approves 2009-2010 flu vaccine; Catalent appoints VP in packaging unit; more...

Devices that measure relative humidity (e.g., sensors and transmitters) play a relatively small role in cleanroom management, but their failure can cause significant problems. Operators should bear several factors in mind to ensure that sensors function properly and maintain the appropriate humidity.