BioPharm News

Sep 06, 2011
BioPharm International
By BioPharm International Editors
EMA announced in a press release that a new version of the validation criteria for electronic applications for human medicines comes into effect on Sept. 1, 2011. The new criteria (version 3.1) have been agreed with the regulatory authorities in European Union member states and will be applied to all electronic common technical document (eCTD) sequences received starting September 1.
Aug 23, 2011
BioPharm International
The second quarter of 2011 presented a mixed picture of financing for the life-science sector, which includes the biotechnology and medical-device industries. Although venture-capital funding for the sector as a whole showed strong improvement, biotechnology investing dropped in terms of overall dollars invested and number of deals.
Aug 23, 2011
BioPharm International
In its latest filing with the Securities and Exchange Commission (SEC) for the quarter ending July 2011, Pfizer indicated that it has voluntarily provided the SEC and the Department of Justice (DOJ) with information concerning potentially improper payments made by Pfizer and Wyeth in connection with sales activities that took place outside of the United States.
Aug 23, 2011
BioPharm International
Since China?s State Food and Drug Administration (SFDA) revised its GMPs last year (they became effective Mar. 1, 2011), the agency has been making other improvements to enhance the quality of its pharmaceutical manufacturing industry. Many improvements are tied to the 2015 deadline SFDA has placed on existing domestic drug manufacturers to implement the revised guidelines. Newly created companies are expected to meet the new GMPs from the start.
Aug 23, 2011
BioPharm International
Bayer Healthcare has pledged its support to a Tuberculosis (TB) partnership by providing 620,000 tablets of the antibiotic moxifloxacin to the World Health Organization (WHO), which will make the tablets available to China?s national TB program. In particular, the medicine will be used to fight multidrug-resistant TB.
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.
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