|
 |
Advertisement:
 Access Training You
Need Now
With over 100 Live and On-Demand Online Training courses, and nearly 300 instructor led courses to choose from - CfPA’s Accredited courses can ensure you receive the skills and knowledge that will make a difference in your career. Register now for: Critical Process Cleaning Jan 25 NJ, Documentation Management Feb 22 NJ, or The Latest FDA Update Jan 21 Online. |
|
|
Arrowhead Research (Pasadena, CA) reports that its wholly owned subsidiary, Tego Biosciences, has completed a definitive asset purchase agreement for the sale of its noncash intellectual property (IP) to Luna Innovations (Roanoke, VA), a developer and manufacturer of nanomedicines. Under the terms of the agreement, Luna paid Tego $430,000 upfront, will make milestone payments totaling $4.25 million for each fullerene product it brings to market under Tego IP, and pay royalties on net sales of its products built with the Tego IP. Also under the terms of the agreement, Tego will receive payments of 10% on revenues from the licensing or resale of Tego’s IP and 50% of net proceeds from products developed under a specific project using Tego IP. The Tego IP includes a broad portfolio of foreign and domestic patents and patent applications relating to modified fullerenes for use in diagnostics, therapeutic, imaging, and other biopharmaceutical-related applications.
Bioject Medical Technologies (Portland, OR), a developer of needle-free injection therapy systems, has established a strategic alliance with the contract research organization MPI Research (Mattawan, MI). The strategic alliance creates a preferred partnership relationship that allows Bioject to gain access to a range of capabilities and resources needed for the company to explore drug and device opportunities, including access to pharmacologic, analytical, safety, and other preclinical testing resources available at MPI Research. The strategic alliance provides MPI Research the opportunity to provide Bioject’s needle-free technology as an alternate delivery option.
Formatech (Andover, MA), a contract development and manufacturing organization, has selected the next candidate for its Fillanthropy program: ViroMed’s (Seoul, Korea) VM206 therapeutic cancer vaccine. Under the Fillanthropy Program, Formatech will donate the services required to aseptically fill and finish one lot of the vaccine to support ViroMed’s upcoming clinical trials. Formatech plans to complete the production run in March 2010.
Advertisement:
analytica, March 23 – 26, 2010 in Munich, Germanyy
The world’s leading trade fair for Laboratory Technology, Analysis and Biotechnology. More than 1,000 exhibitors and 33,000 trade visitors attended analytica 2008. The 2010 show promises to be the most international analytica to date - there has been a 13% increase in international exhibitors so far. More information at  www.analytica.de/en |
Johnson & Johnson Pharmaceutical Research & Development (J&JPRD, Raritan, NJ) reported last week that it received a complete response letter from the US Food and Drug Administration for ceftobiprole. The new drug application was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections including diabetic foot infections. The FDA has requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&JPRD intends to discuss the best path forward with the FDA as soon as possible. Ceftobiprole was licensed from Swiss-based Basilea Pharmaceutica in February 2005. In March 2008, J&JPRD received an approvable letter regarding the ceftobiprole filing. J&JPRD responded to the FDA’s approvable letter in August 2008. In November 2008, J&JPRD received a complete response letter, which recommended additional site audits be conducted. The company completed those audits through a third party and included the results in its June 2009 response to the FDA’s complete response letter.
Novartis (Basel, Switzerland) has agreed to acquire the biopharmaceutical company Corthera (San Mateo, CA) for $120 million. The deal provides Novartis with exclusive worldwide rights (except in Australia and Canada) to relaxin, a recombinant version of a naturally occurring human peptide, which is in Phase III trials to treat patients with acute decompensated heart failure. Novartis will assume full responsibility for the development and commercialization of relaxin, with regulatory submissions in the US and Europe planned for 2013. Corthera’s current shareholders will be eligible to receive additional payments of up to $500 million that are contingent upon clinical milestones, regulatory approval of relaxin, and the achievement of commercialization targets. The transaction, which is subject to customary regulatory approvals, is expected to be completed in the first quarter of 2010.
Teva Pharmaceutical (Jerusalem, Israel) reported last month that Teva-KOWA Pharma, the company's joint venture in Japan, with KOWA Company (Nagoya, Japan) has agreed to acquire a majority of the outstanding shares of Taisho Pharmaceutical Industries (Tokyo). Under the terms of the agreement, Teva-KOWA Pharma will purchase at least 66.7% of Taisho's outstanding shares. Taisho, a privately held company with revenues of $130 million, manufactures and markets a portfolio of over 200 generic products.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com
|
|
Advertisement:
Informex brings together serious buyers and sellers of chemicals, biologics, chemical technologies and related services. It is the global meeting place to efficiently showcase as well as learn about the capabilities of high-value, high-quality fine, specialty and custom chemical manufacturers, from pilot to commercial scale.  Registration is now
open. |
In mid-November, the US Food and Drug Administration held a public hearing to discuss the promotion of agency-regulated drugs and medical devices using the internet and social media tools. See back story and Pharm Tech's Editor-in-Chief Michelle Hoffman’s follow-up editorial on the subject. The full presentations from the meeting are now available on the FDA website.
|
|
The biotechnology company Biogen Idec (Cambridge, MA) reports that James C. Mullen, president and chief executive officer, will retire from his position, effective June 8, 2010. Mr. Mullen will also retire from the company's board upon the completion of his current term as a director at the company's 2010 annual shareholder meeting. The company has initiated a search for Mullen's successor.
Dishman Group (Ahmedabad, India), a contract manufacturer, has appointed Chris Oates to the position of chief operating officer. Oates will report to Nick Green, president of the Dishman global contract research and manufacturing services business. Oates will assume responsibility for Indian and Chinese operations within the company. He will be managing the development, operation, and improvement of the systems in the two manufacturing sites in India (Bavla and Naroda) and the new Shanghai facility, which is due for completion mid-2010. In addition to the units in Naroda and China, Oates will be responsible for the nine operating units at Bavla, including a large scale high-potency facility that will be inaugurated at the end of January.
DPT Laboratories (San Antonio) announced last month that Lyle Flom has been named vice-president of development and commercial services. Flom, who joined DPT in 2001, previously was general manager for plant operations in San Antonio.
Eli Lilly (Indianapolis, IN) reports that Derica Rice, senior vice-president and chief financial officer for Lilly, has assumed expanded responsibilities and has been promoted to executive vice-president of global services and chief financial officer, effective January 1. In this role, Rice will retain his responsibilities as chief financial officer of the company and add responsibility for global services, including the ongoing global services design project, as well as information technology and Six Sigma. Rice joined the company in 1990 as an international treasury associate. He has held numerous leadership roles during his tenure, including chief financial officer for Lilly Canada, executive director and chief financial officer for European operations based in London, and the general manager of Lilly United Kingdom and Republic of Ireland. Prior to becoming Lilly's chief financial officer in 2006, Rice had been the vice president and controller since July 2003. |
|
Advertisement:
 Vetter Development
Service Chicago
Peter Soelkner
Managing Director, Vetter Pharma International GmbH
Listen to this podcast recorded live from the show floor of AAPS 2009. Clinical development is key for new drugs. In order to minimize risks and take advantage of opportunities, you need comprehensive know-how and years of experience. Vetter, as a specialist in the aseptic filling of injection systems, will provide with its new facility the manufacturing of preclinical, Phase I and Phase II clinical batches in Chicago. We invite you to find out more about Vetter Development Services USA Inc.
|
 |
|
2010 Bioprocessing Survey |
|
|
|
Participate in PharmTech's 2010 Bioprocessing Survey. Share your experiences
with cell lines, vaccines, disposables, and more, and you'll be entered into a drawing for a $100 giftcard.
Coming Soon: BIO President and CEO Jim Greenwood discusses healthcare reform in PharmTech’s January 2010 issue. |
|
|
|
|
|
|
|
Pharma’s Economic Recovery
When do you think the pharmaceutical industry will experience an economic recovery?
|
View the poll archive. |
|
|
|
Inspection device offers improved measurements
