News

CDER Director Janet Woodcock announces reorganization.

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

The World Health Assembly, the decision-making body of the World Health Organization, met in Geneva last month to discuss and take action on initiatives relating to influenza pandemic preparedness, noncommunicable diseases, and the health-related UN Millennium Development Goals.

Eduardo Pisani, director general of the International Federation of Pharmaceutical Manufacturers & Associations, discusses the global health initiatives and related activities of the association.

Can microdosing make medicines safer and more effective for children?

An independent report released by the European Medicines Agency highlighted a number of recommendations to aid the agency in its communication of the benefits and risks of medicines.

Why SOPs are rarely followed, often cited, and in need of follow-through.

A Focus on Creative Strategies to Help the Developing World.

Sometimes, there are just too many cooks in the kitchen.

FDA added a searchable database of inspection data to its website. The database lists the names and addresses of facilities that the agency inspected during fiscal years 2009 and 2010.

FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.

This month's BIO Convention will encourage needed conversations.

Mylan, a generic-drug manufacturer, announced that it will be rebranding its Hyderabad, India-based subsidiary, Matrix Laboratories, as Mylan.

The pharmaceutical industry has been called to action by a new report that highlights the health and cost repercussions of patient noncompliance.

During an eight-day series of meetings that concluded on May 24, 2011, the World Health Assembly passed 28 resolutions and adopted three decisions to guide the organization?s work and address global health issues.

Valeant agrees to acquire Sanitas Group; Geron makes several senior appointments; and More.

India's drug pricing authority increased the retail costs of certain domestically manufactured drugs, but not those of imported drug products. Pharma is asking why.

The greatest challenge faced by the EMA is the continuing expansion of the EU.

It was a mixed crowd hosted by Dusseldorf in the middle of May.

America's pharmaceutical research and biotechnology companies are developing 851 medicines for diseases that disproportionately affect American women, says a PhRMA report.

Takeda Pharmaceutical has agreed to acquire Nycomed, a Swiss pharmaceutical company for $13.5 billion, excluding Nycomed's US dermatology business. The deal is intended to increase Takeda's presence in European and emerging markets.

Following recent accusations that the EMA puts companies' commercial interests ahead of public safety, the EMA has responded by emphasizing recent initiatives at the agency to improve data access.

FDA held a joint meeting of its Nonprescription Drugs Advisory Committee and Pediatric Advisory Committee to discuss whether new dosing information for oral over-the-counter drug products containing acetaminophen should be added to the label for children under age 2.

Almac opens new North American headquarters; Sanofi Pasteur appoints Damian Braga as senior vice-president of global commercial operations; and More.

Global spending on medicines will total almost $1.1 trillion by 2015, according to an IMS Institute for Healthcare Informatics study.

Teva Pharmaceutical Industries agreed to pay shareholders $460 million in cash to acquire a 57% stake in Taiyo Pharmaceutical Industry. Teva also will offer to buy all outstanding shares of Taiyo.

A bill was introduced in the US House of Representatives to launch a national strategy for the development of regenerative medicines.

Johnson & Johnson subsidiary Janssen-Cilag International reported that the company is working with regulatory authorities in five countries to address trace amounts of 2,4,6- tribromoanisole identified in five batches of the HIV/AIDS medicine Prezista.

AstraZeneca, GlaxoSmithKline, and the University of Manchester form new research collaboration for inflammation; BASi names Michael Zhou as senior director of R&D; and More.

EMA is working with its European and international regulatory partners to monitor and evaluate ?the possible risk of radioactive contamination of medicines manufactured in Japan following the radiation leak from the Fukushima Daiichi nuclear power plant.?