 |
REACH and CLP USA
August 1, 2012–August 2, 2012
Raleigh, North Carolina
Antibody-Drug Conjugates, Bispecifics & Empowered Antibodies
August 6, 2012–August 8, 2012
San Francisco, California
The Drug Development Process - From Discovery to Commercialization
August 15, 2012–August 17, 2012
King of Prussia, Pennsylvania
CPhI South America
August 21, 2012–August 23, 2012
San Paulo, Brazil
Pharmaceutical Regulatory Summit
August 21, 2012–August 24, 2012
San Francisco, California
|
|
|
 |
 
 |
|
Amicus Therapeutics and GlaxoSmithKline (GSK) have agreed to expand the companies’ collaboration to develop and commercialize the investigational pharmacological chaperone migalastat HCl for treating Fabry disease. Under the expansion agreement, Amicus will commercialize all formulations of migalastat HCl in the US, while GSK will commercialize in the rest of the world. Amicus and GSK will continue to share R&D costs for all formulations of migalastat HCl, with Amicus funding 25% and GSK funding 75% of these costs for monotherapy and coadministration during the remainder of 2012. Amicus and GSK will be responsible for 40% and 60% of these costs, respectively, for coformulation immediately and for all formulations in 2013 and beyond. GSK will make an $18.6-million equity investment in Amicus, bringing GSK's total ownership stake in Amicus to 19.9%. GSK will purchase approximately 2.95 million shares of common stock at $6.30 per share, a 7% premium over the 15-day average closing sale price of Amicus’s common stock as reported by Nasdaq. Read More
Advertisement:
Realize Effective Pharmaceuticals
Reliable solutions enable pharmaceutical scientists to innovate in disease research, accelerate drug discovery and have greater confidence throughout development and manufacturing. Agilent solutions in genomics research, automation, separation and detection technologies along with workflow driven software solutions helps deliver the answers to bring effective therapeutics to market.
Learn about pharmaceutical purification, purity, and impurity analyses at  www.agilent.com/lifesciences/realizepharma |
Pfizer reported that the US District Court for the District of Delaware has ruled in favor of Pfizer and Northwestern University in the Lyrica patent-expiration case. Under the decision, Pfizer will exclusively provide pregabalin as Lyrica to patients through Dec. 30, 2018 in the US, pending generic company appeal and further litigation. Read More
Advertisement:
Annual Product Reviews for the Pharmaceutical and Related Industries
August 13-14 East Brunswick, NJ
This CfPA course will show you that if done properly, the Annual Product Review (APR) report can be a highly valued administrative tool by upper management. Learn to write, implement and manage the Annual Review process. Both US and European approaches covered. Use Priority Code PT200 and Save $200 on tuition. Read More |
Synergy Pharmaceuticals, a biopharmaceutical company, has agreed to acquire the development-stage biopharmaceutical company Callisto Pharmaceuticals. Under the merger agreement, the outstanding shares of Callisto common stock will be exchanged for 0.17 shares of Synergy common stock and the 22,295,000 shares of Synergy held by Callisto will be canceled. The transaction is expected to close by the end of October 2012. Read More
Advertisement:
Maximize GC Headspace Productivity
Develop reliable testing for residual solvents with the Agilent 7697A Headspace Sampler injection system and maximize your precision, accuracy and throughput. Agilent’s method translation tools allow for conversion from other headspace samplers to deliver unparalleled confidence in your analytical results. See the animated demo |
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More
Advertisement:
Handheld Raman Accelerates Raw Material Release
Enwave Optronics introduces the NEW ASSU℞ Handheld Raman Analyzer for raw material verification. Most materials are measured and evaluated within 15 seconds. The ASSU℞ is fully 21 CFR Part 11 compliant for GMP requirements. It is an ideal choice for pharmaceutical, industrial chemicals and applications requiring high speed, reliable Raman analysis. http://www.enwaveopt.com/EZRaman-H.htm |
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected] |
| |
 |
|
|
FDA has released, Guidance for Industry, Q8, Q9, & Q10 Questions and Answers, Appendix Q&As from Training Sessions. The document, prepared by the International Conference on Harmonization's (ICH) Quality Implementation Working Group, presents points to consider in relation to the implementation of ICH Q8(R2), Q9, and Q10. The guidance is based on questions asked during training workshop sessions in three regions and is not intended to be a new guidance. The guidance was written to provide clarity on the quality-by-design (QbD) approach. Topics discussed in the guidance include process validation, design space, and models in QbD.
Advertisement:
Atypical Visible Particles (Black Specks): Approaches for Manufacturers and Users
Live Webcast: Thursday, September 13, 2012 at 11:00 AM EST
Register Free at  www.pharmtech.com/atypical |
Commissioner Margaret A. Hamburg announced on July 23, 2012, that FDA has approved or tentatively approved 152 antiretroviral drugs to treat HIV and AIDS patients through President’s Emergency Plan for AIDS Relief (PEPFAR). Among the tentative approvals given by FDA in association with PEPFAR were to the generic drugs abacavir oral solution (Hetero Labs Ltd.), lopinavir and ritonavir oral solution (Cipla Ltd.), and efavirenz tablets (Edict Pharmaceuticals Private Ltd.). Giving a drug tentative approval in association with PEPFAR, according to an FDA press release, means that although FDA has found that a drug product has met all required requirements, it cannot be approved for marketing in the US because of existing patents or marketing exclusivity. The product is, however, eligible for purchase in foreign markets through the PEPFAR program. FDA expedites all reviews of drug applications and inspections of the overseas facilities received in association with PEPFAR. “PEPFAR is driven by a shared, global responsibility to save lives affected by HIV and AIDS,” said Commissioner Hamburg, M.D., in the press release. “Thanks to the hard work and commitment of hundreds of FDA staff and our partners, we now have safe and effective antiretroviral drugs that are widely available at low cost and in forms that allow for better adherence. Together, we are changing the course of the AIDS epidemic.”
The European Medicines Agency (EMA) has released prevalence data for orphan conditions on its website. The table includes sources previously assessed and accepted by the Committee for Orphan Medicinal Products. EMA decided to make the data, which have been collected over the past 10 years, public to encourage development of rare disease drug products and facilitation the orphan designation process, according to an EMA press release. The table will be updated on a regular basis by EMA.
|
|
 |
| High-Potency Manufacturing Remains Strong |
by: Patricia Van Arnum
Companies roll out expansions in manufacturing high-potency APIs and finished products.
 |
Coming soon: Pharm Tech’s August issue will delve into cargo security and theft prevention in the pharmaceutical industry. |
|
|
|
Know Before You Go—2012 Conference Previews
Visit our Show & Exhibition Gateway 2012 to see which companies are exhibiting at upcoming industry conferences.
Find company backgrounds, new product releases, booth materials, and more.
PharmTech's online
Gateway is your guide to the season's leading shows.
|
|
|
|
|
|
Total organic carbon analyzer tests pharmaceutical water
