BioPharm News

Aug 16, 2011
BioPharm International
FDA scientists published an article in the Aug. 4, 2011, issue of The New England Journal of Medicine that describes their current thinking about a pathway for the regulatory approval of biosimilars. The agency?s approach reflects its examination of EMA guidelines, as well as the nature of biological drugs.
Aug 16, 2011
BioPharm International
Pfizer has partnered with the University of California?s San Diego Health Sciences (UCSD) in a drug-discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies. The partnership will leverage UCSD?s expertise in neurosciences, cancer, inflammation, metabolism, clinical pharmacology, HIV, and pain.
Aug 16, 2011
BioPharm International
By BioPharm International Editors
EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. The collaboration between the EMA, a number of European member states, FDA, and Australia?s Therapeutic Goods Administration (TGA) sought to increase international regulatory information-sharing to enhance global drug quality and safety by building on API GMP standards.
Aug 09, 2011
BioPharm International
By BioPharm International Editors
Last week, the International Society for Pharmaceutical Engineering (ISPE) published a guidance document titled ISPE Good Practice Guide: Process Gases. The guide defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams (e.g., nitrogen, oxygen, argon, carbon dioxide, and compressed air).
Aug 09, 2011
BioPharm International
Last week, Merck & Co. unveiled plans to reduce its global workforce, as measured by year-end 2009 levels, by an additional 12–13% by 2015. The company described its plans in its report on second-quarter earnings, which the company issued on July 29, 2011.
Aug 09, 2011
BioPharm International
In late July, FDA announced the 2012 user fees collected under the Prescription Drug User Fee Act (PDUFA) of 2007. The act stipulates that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of three categories: applications for approval of drug and biological products, establishments where the products are made, and drug and biological products. In some instances, the fees can be waived, reduced, or refunded, as spelled out in an FDA draft guidance issued in March 2011.
Aug 02, 2011
BioPharm International
By BioPharm International Editors
The global production of seasonal influenza vaccine will double to 1.7 billion doses by 2015, according to a presentation given by Marie-Paule Kieny, the World Health Organization?s (WHO) assistant director general for innovation, information, evidence, and research. Kieny spoke at the WHO?s first review of its Global Action Plan (GAP) for Influenza Vaccines on July 12?14, 2011. New manufacturers in 11 developing countries, including Brazil, India, Iran, Mexico, and Vietnam, will be producing vaccines by that time, according to the presentation.
Aug 02, 2011
BioPharm International
FDA released this week a report from its Center for Drug Evaluation and Research (CDER) that identifies regulatory science needs that will guide CDER?s strategic planning in the years ahead and allow it to fulfill its regulatory mission. The report, Identifying CDER?s Science and Research Needs, discusses internal research initiatives and goals for contributing to the agency?s overall regulatory science efforts.
Aug 02, 2011
BioPharm International
The age of globalized industry should result in fewer barriers between countries, but it is rarely that straightforward in practice. At the India?US Strategic Dialogue held in New Dehli on July 19, 2011, India?s junior science minister Ashwani Kumar complained to US presidential science adviser John Holdren that a new US visa policy is hampering the ability of Indian scientists to travel to the United States, according to a report by ScienceInsider. Kumar asked that the procedure be streamlined. Indian scientists, even top aides to the government, are now required to renew their visa annually, but they previously could obtain a multiple-entry visa every 5 to 10 years. This change makes it difficult for Indian scientists to attend conferences in the US or engage in any other frequent, short-duration travel without attending to yearly paperwork. ?I understand the visa issue is a problem and a challenge, and we hope to improve it,? said Holdren, according to ScienceInsider.
Aug 02, 2011
BioPharm International
Bristol-Myers Squibb (BMS) has signed an agreement to acquire Amira Pharmaceuticals, a small-molecule company with a focus on treatments for inflammatory and fibrotic diseases for $325 million. The amount will be paid upfront, but there is potential for additional milestone payments up to $150 million. The acquisition represents BMS?s entrance into the fibrotic diseases area, which the company says is an area of high unmet need.
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