Pharmaceutical Technology ePT Weekly:
Having trouble viewing this e-mail? Click here.
You are subscribed to %%list.name%% as %%emailaddr%%.
Click here to unsubscribe your member profile
ePT by PharmTech logo
News
Company Notes

Regulatory Roundup

Product Spotlight
People Notes
PharmTech,
the magazine

Advertisement
 
 

About Us

Subscribe to Pharmaceutical Technology

Whitepaper Library

Podcasts

Webcast: Formulation Development Strategies
September 28, 2011—Sponsored by BASF

Webcast: Preventing Costly Out-of-Specification Investigations
September 20, 2011—Sponsored by Mettler-Toledo

Webcast: Winning Regulatory Strategies and Opportunities in Dermatology
July 20, 2011—Sponsored by Dow Pharmaceutical Sciences

Webcast: Quality Control: Preventing Cross-Contamination in a Pharmaceutical Manufacturing Environment
June 21, 2011 (North America) and June 23, 2011 (Europe)—Sponsored by SGS

Podcast: A Conversation with NIH Director Francis Collins

USP Symposium 2011 Preview

Events

ChemOutsourcing
September 12, 2011–September 15, 2011
Long Branch, New Jersey

IVT's 2nd Annual West Coast Forum on Supplier Audits
September 13, 2011–September 15, 2011
San Diego, California

Pharma eMarketing Congress 2011
September 13, 2011–September 14, 2011
Lisbon, Portugal

Impurities 2011
September 14, 2011–September 15, 2011
Prague, Czech Republic

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

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

More events


FindPharma Search
September 8, 2011 PharmTech.com

News

FDA Issues Letter to Pfizer Regarding Violative Online Marketing
FDA's Division of Drug Marketing, Advertising, and Communication issued a letter to Pfizer's vice-president of US Regulatory Affairs regarding its online resources page for Lipitor tablets.
Click Here to Read More

Generic Drug User Fee Agreement Nears Completion
Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act. Click Here to Read More

Sanofi Outlines Long-Term Objectives
Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.
Click Here to Read More

Pfizer Completes Tender Offer For Icagen
Pfizer has completed its cash tender offer for the biopharmaceutical company Icagen (Durham, North Carolina) after extending its initial deadline. The tender offer of $6 per share was originally scheduled to expire on Aug. 31, 2011, but was extended twice after insufficient shares were tendered.
Click Here to Read More


Product Spotlight

Dry bulk-material handling system increases process efficiency

National Bulk Equipment offers a bulk-bag unloading system designed and built for applications in regulated process industries. The system’s angled-plane framework with rounded radii reduces material accumulation and speeds moisture removal during washing in place. Operators can access the system’s component enclosures easily, which simplifies validation and inspection. In addition, the system’s process controls and automation comply with the specifications of the International Organization for Standardization.

A bulk-bag conditioner is integrated directly into the bulk-bag unloader’s structural framework. This design eliminates the repetitive loading and unloading that freestanding bag conditioners require and reduces the process to a single load–unload cycle. During an 8-h shift, the system’s integrated bag conditioning can increase the total number of bags processed from 12 to 16, according to the company.

The bulk-material handling system is built to handle free-flowing and fine materials, which are common to the pharmaceutical industry. Its dry and liquid product contact areas are constructed of 304–2b stainless steel.

Company Notes

Addex Pharmaceuticals, a biopharmaceutical company, has announced that it will regain all rights to its metabotropic glutamate receptor 4 positive allosteric modulator program from Merck & Co. due to further pipeline prioritization. Under the agreement, Addex will regain rights to intellectual property and pursue the program independently.

Advertisement:
Need testing for residual solvents and particulates?
Celsis Analytical Services is current on all USP changes including <788>. If you need particulate or residual solvent testing, we have the equipment and the experienced analysts to do the job-- on time and on budget. We also offer method feasibility, development and validation.
Request a quote online at Celsis.com/quote or call us, toll-free (888) 468-3400.

The Department of Energy’s Argonne National Laboratory broke ground on a $34.5-million, 50,000-ft2 Advanced Protein Crystallization Facility (APCF) that will enable scientists to produce, purify, and characterize a wide range of proteins. The State of Illinois will provide funding for the design and construction of the APCF, which is slated to open in 2014.

Advertisement:
Catalogs of Innovative Clean Room and Lab Equipment - Get competitive pricing and full technical specifications on popular lines of laboratory products from Terra Universal. Download Terra's lab equipment catalogs for application details on controlled-temperature systems, sample preparation equipment, and analytical instrumentation. Terra also manufactures a complete line of critical environment enclosures, including hoods, isolation chambers, desiccators, modular clean rooms and pass-through chambers.

AstraZeneca has completed the $1.8-billion sale of its Astra Tech dental- and healthcare-products business to Dentsply International, a dental-products company. The transaction closed on Aug. 31, 2011.

Advertisement:
Pharmaceutical starches from Grain Processing Corporation (GPC) range from basic unmodified starches for tableting to very specialized, innovative starches for unique applications. Spress®; Pregelatinized Corn Starches NF perform as binders, disintegrants and lubricants for granulations, direct-compression tablets, capsules, dry blends and roller compaction. PURE-COTE® film-forming starches are designed for coating applications, oral thin films, capsules and any applications where clear, flexible films are required. Learn more.

Baxter’s BioPharma Solutions business has completed its latest capacity expansion at the company’s cytotoxic contract-manufacturing facility in Halle/Westfalen, Germany. The primary component of the expansion was the modular installation of an additional large-scale, commercial lyophilization unit for increasing freeze-drying capacity to support commercial cytotoxic manufacturing capacity. The freeze dryer, which is now in operation, was designed to meet international manufacturing and regulatory requirements.

Advertisement:
The Silverson Verso In-Line Laboratory mixer is the result of 60+ years of mixing experience and untold hours of scale-up research. This bench top In-Line mixer bridges the gap between laboratory and full-scale pharmaceutical production, providing proven, predictable accuracy. The Verso allows reliable forecasting of the performance of larger Silverson In-Line mixers under full-scale conditions. For a free on-site trial call 413-525-4825.

DMV–Fonterra, an excipients-development company, has agreed to acquire the business and assets of Brahmar Cellulose Private Limited, an Indian-based producer of pharmaceutical microcrystalline cellulose and sodium carboxyl methyl cellulose. The acquisition, subject to customary closing conditions regulatory approval, is scheduled to close in the fourth quarter of 2011.

 

DSM, has established a 50–50 joint venture for its business group DSM Anti-Infectives with Sinochem Group. As part of the agreement, Sinochem has taken a 50% interest in the business group for EUR 210 million ($295 million). The joint venture will be headquartered in Hong Kong and will be part of a new group, DSM Sinochem Pharmaceuticals. The joint venture includes all of DSM’s anti-infectives activities.

Advertisement:
Covance, one of the world's largest and most comprehensive drug development services companies, now offers a comprehensive and integrated set of CMC Pharmaceutical Development Services, including API development and supply, preformulation and formulation, analytical and stability, and regulatory documentation services. This offering is built on the combination of top-five pharma expertise, facilities, and decades of excellent client service record. Covance is committed to helping you reduce the time required to development milestones and improve your molecule hit rate. www.covance.com/cmcpds

The drug-development company Evotec and Roche have entered into an agreement for the development and commercialization of Evotec’s monoamine oxidase B inhibitor in patients with Alzheimer’s disease. Under the terms of the agreement, Roche will pay Evotec an upfront fee of $10 million. Evotec could receive further development and commercial milestone payments of up to $820 million as well as tiered double-digit royalties on sales. Roche will initiate studies in 2012 to demonstrate proof of concept and will be responsible for all clinical development, manufacturing, and commercialization activities.

Advertisement:
At Solvay Chemicals, we manufacture BICAR® Sodium Bicarbonate and Soda Ash IPH to meet the exacting specifications of the US and EP Pharmacopeias and National Formulary. Produced according to cGMP, these are the products of choice for API or excipient applications requiring effervescent or desiccant properties. Solvay Chemicals, Inc. is part of the Solvay Group, the leading global producer of sodium bicarbonate and soda ash. http://www.solvaychemicals.us/marketsapplications/marketshidden/0,,40615-2-0,00.htm

GlaxoSmithKline (GSK) and the biopharmaceutical company Anacor Pharmaceuticals have expanded their R&D collaboration, providing GSK the option to extend its rights around the bacterial enzyme target leucyl-tRNA synthetase (LeuRS), as well as to add new programs for tuberculosis (TB) and malaria using Anacor’s boron chemistry platform. As a result of the amendment, Anacor will receive a $5-million upfront payment as well as additional potential milestones and research funding of up to $11.3 million by the end of 2012. Anacor is also eligible to receive additional milestones and royalties on future sales of resulting products. The original R&D collaboration was formed in October 2007 for the discovery, development, and worldwide commercialization of boron-based systemic anti-infectives against four discovery targets, including LeuRS. As part of the current amendment, all rights to the other three original targets will revert to Anacor. The amendment also includes the option for GSK to acquire rights to Anacor’s malaria program, focused on development of the lead compound, AN3661, currently being developed through a collaboration with Medicines for Malaria Venture.

Advertisement:
QUALITY TABLET PRESS REPLACEMENT PARTS SHIPPED SAME DAY!
By stocking over 300,000 replacement parts for nearly every press on the market, we're able to provide quality parts at incredible prices, faster than anyone else in the industry. All Natoli replacement parts are manufactured in the U.S.A. and are available for international delivery – and most items are available with same-day shipping!.
Request a FREE QUOTE now!

Huber Engineered Materials (HEM), a specialty-ingredients provider, has announced an expansion of its Quincy, Illinois, manufacturing operations to accommodate additional capacity for calcium carbonate granulation production for its health and nutrition unit. HEM is targeting the second quarter of 2012 for the facility to become operational, and is planning to generate nearly 10,000 metric tons of calcium carbonate granulation annually. The expansion will be integrated into the existing HuberCal calcium carbonate milling operations and significantly increase GMP capabilities at the Quincy site.

Advertisement:
Meet NSF-DBA this month at PDA/FDA Conference
2011 PDA FDA Joint Regulatory Conference | September 19-21, 2011 Renaissance Hotel | Washington, D.C. | Table/Booth # 8
NSF-DBA will be exhibiting at the 2011 PDA FDA Joint Regulatory Conference
Contact us at: USinfo@nsf.org to arrange a meeting.
Come and see us to learn about QLP, in-house training, consultancy and auditing services.
Series 2, starting Nov. 2011 Download our QLP 2 Brochure

Cancer Research Technology (Cancer Research UK’s commercial arm) and the University of Cambridge (led by Professor Stephen Jackson) have announced the launch of Mission Therapeutics, with Series A funding from a venture capital syndicate. The new spin-out biopharmaceutical company will translate cell biology research on DNA repair from Professor Jackson’s laboratory at the Gurdon Institute at the University of Cambridge, into drugs for treating cancer. The company will be based on the Babraham Research Campus, Cambridge, United Kingdom. The company will predominantly conduct research on ubiquitin pathways that control cellular responses to DNA damage. The company has raised £6 million ($9.58 million) in Series A-funding from a strong venture capital syndicate led by Sofinnova Partners, and comprising Imperial Innovations, SR One, and the Roche Venture Fund.

Advertisement:
For active and passive transdermal drug delivery contract manufacturing, contact Tapemark. http://www.tapemark.com/transdermal.html

Oxigene, a biopharmaceutical company, has announced a restructuring plan that will terminate the employment of 11 full-time workers. The company is offering severance benefits to the terminated employees and anticipates recording a total charge of approximately $1.2 million, primarily associated with personnel-related termination costs. Approximately $1.1 million of the restructuring charge will be taken in the third quarter of 2011, with the remainder being taken over the following two quarters as the transition is effected.

Advertisement:
5th Annual Pharma/Biotech Collaboration Accounting and Transaction Strategy
On September 21st, join your industry colleagues in Philadelphia, PA to hear accounting best practices and financial due diligence for strategic R&D deals, transactions, licensing and revenue arrangements.
www.cbinet.com/collaboration | 800-817-8601 | cbireg@cbinet.com

Pfizer has entered into a 10-year lease agreement with the Massachusetts Institute of Technology (MIT) for more than 180,000 square feet in a new building under development in Cambridge, Massachusetts. The new site will be the future location of Pfizer’s cardiovascular, metabolic, endocrine disease, and neuroscience research units. Pfizer expects to move into interim space as the new space is completed, which is expected to occur in the fourth quarter of 2013.

Advertisement:
Interactive Response Technologies for Clinical Trials — November 14-15, 2011, Philadelphia, PA
Don't miss the opportunity to learn from industry peers in the only dedicated Clinical IRT platform. Hear from ivr/iwr leaders from Johnson & Johnson Vision Care, Millennium Pharmaceuticals, Novartis, Allergan, Merck Research Laboratories, and Shire Pharmaceuticals. Be the next to benefit. Register today at www.cbinet.com/IVR

Santhera Pharmaceuticals, a specialty pharmacetical company, has announced plans to restructure its operations in North America, and intends to cut its workforce from 47 to 26 employees.

The biopharmaceutical company Selecta Biosciences has announced that Science Applications International (SAIC) has awarded Selecta a subcontract to develop a targeted synthetic vaccine particle product for malaria. Funding for the initiative will be provided by SAIC through its Malaria Vaccine Production and Support Services contract with the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. Under the terms of the award, the targeted synthetic vaccine particle vaccine for malaria will be developed by Selecta for testing in preclinical studies by SAIC collaborators.

Synageva BioPharma, a biopharmaceutcial company, has formed an R&D partnership with Mitsubishi Tanabe Pharma to develop a therapeutic for an undisclosed orphan disease using Synageva’s product-development capabilities and proprietary protein-expression platform. The agreement stipulates an initial target for the research program. Under the terms of the agreement, Mitsubishi Tanabe Pharma will make an upfront payment of $3 million and will contribute additional research funds.

Tekmira Pharmaceutcials, a biopharmaceutcial company, has obtained an exclusive, worldwide license to a proprietary RNAi technology called MV-RNA (multivalent RNA) from Halo-Bio RNAi Therapeutics. The exclusive license and collaboration agreement provides for the companies to work together to design and develop MV-RNA molecules to gene targets of interest to Tekmira and to combine MV-RNA molecules with Tekmira's lipid nanoparticle technology to develop therapeutic products.

Zymeworks, a biotechnology company, has formed a research collaboration with Merck & Co., around Zymeworks’ proprietary Azymetric platform for the development of novel bispecific antibody therapeutic candidates, which are designed to bind to two different drug targets for broad use in clinical applications such as oncology or autoimmune disease. Under the terms of the agreement Zymeworks has granted Merck, through a subsidiary, a worldwide license to develop and commercialize bispecific antibodies generated through use of the Azymetric platform toward certain exclusive therapeutic targets. Both companies will collaborate to advance the technology platform, with Merck working to progress the bispecific therapeutic antibody candidates through clinical development. Zymeworks will receive an upfront fee and is eligible to receive research, development, and regulatory milestones with a potential value of up to $187 million, as well as tiered royalty payments on sales of products. Merck will have exclusive worldwide commercialization rights to products derived from the collaboration.

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

Xoma, a company specializing in antibody discovery and development, has announced that Steve Engle has resigned from his positions as CEO, president, and chairman of the board, effective Aug. 31, 2011. As a result, the board has appointed John Varian, a current board member, as interim CEO, and W. Denman Van Ness, Xoma’s lead independent director, as chairman of the board. The board is initiating a search for a permanent CEO.

Regulatory Roundup

The US Pharmacopeia (USP) opened last week a newly expanded state-of-the-art facility in the IKP Knowledge Park of Hyderabad, India. The facility expands USP’s presence in the area from 14,000 square feet to more than 100,000 square feet. An additional 20 employees, from the base number of 70, will be added throughout the coming year.

Former FDA Commissioner Dr. Charles Edwards has passed away. During his tenure, "Dr. Edwards was one of the country’s most ardent drug safety advocates, ordering the extensive review of over-the-counter drugs for safety, effectiveness, and accuracy in labeling," wrote current Commissioner Margaret Hamburg in a letter on the FDA website. Dr. Edwards led FDA from December 1969 to March 1973, during which time he steered the agency towards a greater regulatory role and helped to double the agency’s budget.

PharmTech, the magazine
Current Issue cover
Has Outsourcing Derailed PAT and QbD?
By Daniel R. Matlis
Quality management requires more effort in a complex supply chain.
Click Here to Read More

Coming soon: The PharmTech October issue features a unique FDA-PQRI report on process drift.

 

 

 

PharmTech Poll

Quality by Design and APIs
Is quality by design changing the expectations between sponsor companies and contract service providers when outsourcing API development and manufacturing?

Vote here
View the poll archive.

On Our Blog PharmTech Talk

>>Recent Posts

Industry Conferences, Regulation
Compliance is Focus of Upcoming PDA-FDA Meeting

Biotech, R&D, Regulation
Regulating Synthetic Biology: How Much or How Little?

Global Health, Information Technology, North America News
RxResponse Monitors Pharma Supply Chain During Disasters

R&D, Trends
Roche Takes a Step Forward with Personalized Medicine

>>Go to the Blog Homepage

| Subscribe | Send Feedback | Advertise With Us | Visit PharmTech.com |

You are subscribed to %%list.name%% as %%emailaddr%%. Click here to unsubscribe your member profile.

To ensure delivery to your Inbox, please add %%email.list%% to your address book. If you need help doing this, click here.

Advanstar Communications provides certain customer contact data (such as customers' names, addresses, phone numbers and e-mail addresses) to third parties who wish to promote relevant products, services and other opportunities which may be of interest to you. If you do not want Advanstar Communications to make your contact information available to third parties for marketing purposes, simply call (toll free) 1-866-529-2922 at any time, or fax us at 1-218-740-6417. Outside the U.S., please phone 1-218-740-6395. Contact us by mail at Advanstar Communications Inc., 131 West First St., Duluth, MN 55802-2065, USA.

Visit PharmTech.com Visit PharmTech.com About Us Subscribe Today! Start your RSS subscription today! Manufacturing Outsourcing Formulation Ingredients Testing Drug Delivery IT Packaging Regulation Visit PharmTech.com