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Webcast: Formulation Development Strategies
ON DEMAND—Sponsored by BASF

Webcast: Preventing Costly Out-of-Specification Investigations
ON DEMAND—Sponsored by Mettler-Toledo

Webcast: Winning Regulatory Strategies and Opportunities in Dermatology
ON DEMAND—Sponsored by Dow Pharmaceutical Sciences

Webcast: Quality Control: Preventing Cross-Contamination in a Pharmaceutical Manufacturing Environment
ON DEMAND series—Sponsored by SGS

Podcast: The Case for Upgrading Existing HPLC Assays to UPLC (Impact Analytical)

Podcast: Step-by-Step Validation for Bio/Pharmaceuticals: Meeting New Regulatory Expectations (Compliance Insight)

Podcast: Considerations in ophthalmic formulation development for various ocular diseases (Dow Pharmaceutical Sciences)

Podcast: A Conversation with NIH Director Francis Collins

USP Symposium 2011 Preview

Events

IVT's 17th Annual Validation Week
October 24, 2011–October 26, 2011
Philadelphia, Pennsylvania

INTERPHEX Puerto Rico 2011
October 20, 2011–October 21, 2011
San Juan, PR USA

AAPS 2011
October 23, 2011–October 27, 2011
Washington DC, USA

CPhI Worldwide 2011
October 25, 2011–October 27, 2011
Frankfurt, Germany

4th West Coast Forum on Clinical Supply Chain Management
December 6, 2011–December 7, 2011
Burlingame, California

More events


  FindPharma Search
September 29, 2011 PharmTech.com

News

FDA Publishes Guidance on Marketed Unapproved Drugs
FDA has published a guidance on Marketed Unapproved Drugs—Compliance Policy Guide, which describes the agency’s enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.
Click Here to Read More

New FDA Guidance on User Fee Waivers, Reductions, and Refunds
FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA’s policies for issuing waivers, refunds, or reductions in prescription drug user fees. Click Here to Read More

EMA Committee Offers Positive Opinion on New Drugs, Moves Forward with Key Concept Papers
The latest meeting of the EMA’s Committee for Medicinal Products for Human Use has concluded with more than 15 positive opinions for new and generic drugs and the adoption of key concept papers.
Click Here to Read More


Product Spotlight

Software measures nanoparticle concentrations

The new version of NanoSight’s Nanoparticle Tracking Analysis (NTA) software platform counts 30–1000-nm particles in suspension and measures their concentration. The system rapidly characterizes the size and concentration of nanoscale protein aggregation in the presence of a large, nonaggregated protein population. Users can distinguish labeled particles from each other using the technique’s fluorescence mode. In addition, the software measures the concentration of virus or viruslike-particles more quickly than the plaque-assay technique does, according to Patrick Hole, head of development at NanoSight. Unlike other particle-sizing software, the NTA software gives the user a visual validation of the source of the raw data, thus allowing him or her to identify potential measurement problems easily. The software complies with 21 CFR Part 11 by protecting recorded data from tampering, attributing data to individual users, and restricting certain functions to supervisors. The product also satisfies quality-assurance reporting requirements.

Company Notes

Boehringer Ingelheim plans to establish a new and separate business for the development and commercialization of its own biosimilars. The company made the announcement in a Sept. 26, 2011, press statement and did not offer further details.

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Bristol-Myers Squibb (BMS) and the biopharmaceutical company Ambrx have formed a collaboration under which BMS will receive exclusive worldwide rights to research, develop, and commercialize biologics based on Ambryx’s research surrounding the fibroblast growth factor 21 (FGF-21) protein for treating Type II diabetes and the hormone Relaxin for treating heart failure. Derivatives of FGF-21 and Relaxin were developed using Ambryx’s ReCODE platform technology, which is used to modify native proteins with nonnatural amino acids. Under the agreement, BMS will make an upfront payment of $24 million to Ambrx and will make potential milestone payments and royalty payments on worldwide sales for both programs.

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GlaxoSmithKline (GSK) has received a Complete Response letter from FDA for its biologics license application for the candidate meningococcal and Hib combination vaccine, MenHibrix (Hib-MenCY-TT).  This is the second response letter GSK has received for Hib-MenCY-TT. GSK said it will respond to the questions posed by FDA.

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Illinois Governor Pat Quinn has signed of a memorandum of cooperation between the Illinois Science & Technology Coalition, an Illinois-based association that represents research universities and technology companies, iBIO, an Illinois-based life sciences industry association, and China-based Shanghai Bio Pharmaceutics Association to increase economic opportunities for both regions in biotechnology.

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Isis Pharmaceuticals, a pharmaceutical company specializing in antisense drug technology, has filed a patent-infringement lawsuit against the biopharmaceutical company Santaris Pharma in the US District Court of the Southern District of California. Isis' infringement suit against Santaris is based upon Santaris' activities providing antisense drugs and antisense drug-discovery services to several pharmaceutical companies. In other news, Isis has completed a new 176,000-ft2 corporate and research facility in Carlsbad, California.

Merck KGaA has acquired from the biopharmaceutical company Peptimmune worldwide exclusive rights to PI-2301, a second-generation peptide copolymer, which is being developed for multiple sclerosis.

Merck & Co. has opened a new EUR 100 million ($136 million) R&D Center in Ballydine, Ireland.  Construction on the new R&D facility at the existing Ballydine site began in September 2007. An additional EUR 6 million ($8.1 million) investment is in the planning phase to extend the new facility and add extra capacity, according to a press release by IDA Ireland, the economic development board of Ireland.

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The biopharmaeutical company RXi Pharmaceuticals will separate its programs into two publicly traded companies: Galena Biopharma, which will focus on the development of targeted cancer therapies, and RXi Pharmaceuticals, which will focus on the development of RNAi-based therapeutics. In connection with these transactions, the company has changed its name to Galena Biopharma.

Sanofi reported that the US District Court of New Jersey has ruled against Sun Pharmaceutical in favor of Sanofi US with respect to a contractual dispute arising from the resolution of patent litigation of the anticancer drug Eloxatin (oxaliplatin). The ruling maintains Eloxatin’s marketing exclusivity through Aug. 9, 2012.

In other news, Sanofi Pasteur, the vaccines division of Sanofi, has formed a R&D collaboration with the University of California, San Diego on immunological approach to acne prevention and treatment. 

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Silence Therapeutics, a RNA interference (RNAi) therapeutics company, formed an agreement with an undisclosed global pharmaceutical companies to investigate the application of Silence’s proprietary lipid delivery system, DACC, for intravenous delivery of short interfering RNA sequences (siRNAs) to the pulmonary vascular endothelium. Under the agreement, Silence’s partner will provide Silence with specific siRNAs, which Silence will formulate with its DACC delivery system. Silence and its partner will undertake in vitro and in vivo studies of the DACC formulated siRNAs developed under the agreement and select lead candidates for further evaluation. Financial terms were not disclosed.

Teva Pharmaceutical Industries has agreed to acquire the 50% interest formerly held by Kowa in Teva's Japanese joint venture for $150 million.  With this acquisition, Teva will own 100% of the former joint venture.

Unigene Laboratories, a provider of drug-delivery and manufacturing technologies for peptides, has divested its Site Directed Bone Growth (SDBG) business by assigning seven patent applications to Kieran Murphy, a development-stage company. In addition, Unigene terminated an exclusive license agreement and consulting agreement with Kieran Murphy as well as a license option agreement and research agreement with Yale University. In exchange for the assignment of the patents, Unigene will receive sales royalties in excess of 7%, 40% of any future licensing revenue, and/or 40% of all considerations received upon the subsequent sale of the SDBG patent portfolio by Kieran Murphy.

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com

People Notes

Merck & Co. has appointed Cuong Viet Do as chief strategy officer, effective Oct. 3, 2011. He will be responsible for developing and executing enterprise-wide strategy and further building connections between the current and future business plans of Merck's franchises, divisions, and functions. He will report to Kenneth C. Frazier, Merck's president and CEO, and will serve on the company's executive committee. He succeeds Mervyn Turner, who retired from the company this summer. Do was formerly senior vice-president of corporate strategy and business development at TE Connectivity, formerly Tyco Electronics. He currently sits on the board of WuXi AppTec, a pharmaceutical R&D outsourcing company

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The CDMO NextPharma announced that Bill Wedlake, CEO of NextPharma Chief Executive Officer will step down effective Sept. 30, 2011. Franck Latrille will become new CEO, effective. Oct. 3, 2011. The rest of the NextPharma executive management team remains unchanged.

PharmTech, the magazine
Current Issue cover
PQRI Case Study: Facility Biocontainment and Inactivation
Ted Frank, Stephen Brooks, Kristin Murray, Steve Reich, Ed Sanchez, Brian Hasselbalch, Kwame Obeng, Richard Creekmore
The third in a series of eight case studies from the Product Quality Research Institute focuses on facility biocontainment and inactivation.
Click Here to Read More

Coming soon: Pharm Tech’s October issue features perspectives from FDA and PQRI on process drift.

 
 
 

 

 

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