News

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.

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.

Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal. Preuse filter-integrity testing provides evidence that a filter will perform correctly, has the right pore size, and has been installed correctly.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the July 2009 edition from Mettler Toledo Safeline and Munters.

Also, Lonza and Medarex sign agreement; Covance appoints VP and chief scientific officer of global analytical services; more...

In the wake of Dow Chemical?s announcement that it is to close facilities in the UK, the country?s biggest union, Unite, has called for urgent intervention from the Government to avert, what it believes, could be a crisis in the UK chemical sector.

The US Food and Drug Administration issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13.

The pharmaceutical industry is paying more attention to less well-known tropical diseases, according to a report from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).

The Society of Chemical Manufacturers and Affiliates (SOCMA) this week stated its support to the US Senate for approving legislation that would extend existing chemical security standards for one more year.

Last week, the House of Representatives passed H.R. 2997, the Fiscal Year 2010 Agriculture?FDA Appropriations bill, which sets aside $2.995 billion for the US Food and Drug Administration.

This week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) issued their opposing statements in reaction the July 13 passage of an amendment from the US Senate Committee on Health, Education, Labor, and Pensions (HELP) regarding the creation of a pathway for the approval of new competitors of biologic drugs.

The European Commission adopted the final report on its anticompetitive inquiry into the pharmaceutical sector on July 8, 2009.

The National Institutes of Health (NIH) issued on July 7, 2009, final guidelines for human stem-cell research that widen the door to the cell lines that can be used if they meet certain ethical requirements.

Also, Lundbeck acquired LifeHealth; FDA is seeking a director of its new tobacco regulation branch; Charles River Labs announces personnel changes; more...

The US Pharmacopeia is revising its monographs for four pharmaceutical excipients: propylene glycol, sorbitol solution, sorbitol sorbitan solution, and noncrystalllizing sorbitol solution.

Roche has officially withdrawn from the Pharmaceutical Research and Manufacturers Association (PhRMA) after being a member for 36 years.

Johnson & Johnson has agreed to pay $1.0 billion to acquire the assets and rights of the Alzheimer's immunotherapy program of the biopharmaceutical company Elan, form a new company with Elan based on the AIP program, and gain an 18.4% stake in Elan.