Industry Briefs: April 1, 2013 - Pharmaceutical Technology

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Industry Briefs: April 1, 2013
A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Avantor Performance Materials, a global manufacturer of chemistries and materials, announced that its unit in India, formerly RFCL Limited, has changed its name to Avantor Performance Materials India Limited. The unit is a provider of chemicals and other products to laboratory, pharmaceutical and diagnostics customers in India. It employs approximately 320 people. Read More (PDF)

Bone Therapeutics, a biopharmaceutical company focused on cell-therapy products for the treatment of bone diseases, announces that it has been awarded both Tissue Establishment and GMP Accreditation for the manufacturing of its Allob allogeneic bone cell-therapy product, being initially developed for the treatment of impaired fractures. The Tissue Establishment (i.e., intermediate structure) Accreditation is a pre-requisite for the manufacture of allogeneic cell therapies, and will permit Bone Therapeutics to have enhanced control over the Allob production line. Bone Therapeutics’ Intermediate Structure will be able to process, preserve, store and distribute human tissues upon their release from LTCG, the Tissue Bank. Bone Therapeutics will work in collaboration with the LTCG, the accredited Tissue Bank from the CHU Sart-Tilman based in Liège, Belgium, and headed up by Professor Yves Beguin. Read More (PDF)

Dalton Medicinal Chemistry has received a notice of award from the National Institute On Drug Abuse (NIDA) to research and discover a novel series of compounds with the potential to treat drug abuse and alleviate pain. This work will be supported by NIDA of the National Institutes of Health (NIH) under Award Number R21DA036251, which includes funding for the project. Dalton Medicinal Chemistry will design, synthesize, and test several novel classes of compounds for these applications. The goal of this research work is to identify and establish candidates for further development towards a future drug product. Read More

ReSearch Pharmaceutical Services (RPS) a contract research organization (CRO), and Asklep, a Japan-based CRO, have formed a joint venture company to provide R&D outsourcing solutions in Japan to the biopharmaceutical and medical device industries. The exclusive RPS–Asklep collaboration will leverage RPS’ proprietary structures and global footprint to deliver customized solutions across large, mid-size, small, and virtual organizations. Options include embedded, hybrid, and full-service solutions will be available to clients using best-in-class standard operating procedures, processes and systems. Alan Morgan, RPS’ Chief Operating Officer, will assume the role of CEO of the joint venture, in addition to his current responsibilities. Read More

Senova Systems’ pHit Scanner was voted the top new product at Pittcon 2013 by editors covering the show in Philadelphia. The Pittcon Editors’ Awards, started in 1996, recognize companies with the most significant and innovative new product introductions at the weeklong conference and exhibition. Editors nominate up to three new products and each nomination is subsequently presented, discussed and voted upon during a private roundtable discussion. The pHit Scanner is a calibration-free pH meter and Senova Systems’ first product offering. Read More

The US Department of Defense (DoD) has awarded to New Jersey Medical School-UMDNJ and an international consortium consisting of Euprotec and Fulhold a $1.53 million contract (W81XWH-12-2-0076) to develop a new product that could save the lives and hasten recovery of soldiers on the front-line. Euprotec, a UK-based specialist contract research organization, is collaborating with Mauritius-based Fulhold and the New Jersey Medical School-UMDNJ, following funding from the DoD, to evaluate a topical broad spectrum antimicrobial agent for use in US soldiers’ battle-packs. It is proposed that, when applied to a battlefield wound, the product will prevent a broad range of posttraumatic microbial infections, which could otherwise prove fatal if left untreated. The Fulhold product, carbohydrate derived - fulvic acid (CHD-FA), has a novel mechanism of action with no reservoir of natural resistance. CHD-FA demonstrates a range of antimicrobial activity against a large range of multidrug resistant gram-positive and gram-negative bacteria such as MRSA, NDM-1 positive E. coli, carbapenem-resistant enterobacteriaceae, tuberculosis, and pathogenic fungi. The DoD contract has been awarded to fund extensive research, in order to accelerate the development of the product for treatment of US soldiers, in a bid to reduce the significant morbidity and mortality caused by traumatic wound infections. CHD-FA is likely to be particularly suitable for use in soldiers’ battle-packs or first aid situations as it is safe and stable at high temperatures. Read More

The CDMO Vetter’s new center for visual inspection and logistics passed its first GMP inspection by FDA. The inspection was conducted Mar. 11–14, 2013, to ensure the facility is in compliance with GMPs. The facility was already granted manufacturing approval and cGMP certification for Europa from the RP Tuebingen, Germany in 2012. The 18,000-m2 facility, known as Ravensburg Vetter West, began operations in April 2012. The site provides high-bay warehousing for cold storage and room-temperature products, as well as visual inspection. Read More

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
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