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Podcasts

Webcast: Hot Melt Extrusion from API to Medical Device Design
October 18, 2011—Sponsored by C.W. Brabender Instruments Inc.

Webcast: Cost-Effective Solutions for Long-term IP Protection in Your Electronic R&D Environment
October 20, 2011—Sponsored by Surety

Webcast: ACQUITY UPLC I-Class System Strategies for Exploiting Sensitivity of Modern MS Detection
October 25, 2011—Sponsored by Waters Corporation

Webcast: Cell-Line Development for Biomanufacturing: Considerations for Optimizing Mammalian Cell Lines
October 27, 2011–Sponsored by Mirus Bio

Podcast: US Pharmacopeia Leaders Discuss the Future of Biologics and Biosimilars Featuring USP's Tina Morris and Matthew van Hook, and Engel & Novitt's Gillian Woollett

Podcast: Vetter's Chicago Facility Fully Operational (Vetter)

Podcast: CPhI Show Daily Podcast Series

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

Events

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

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

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

Introduction to Good Clinical Practices and Auditing
October 26, 2011–October 28, 2011
Horsham, Pennsylvania

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

More events


FindPharma Search
October 20, 2011 PharmTech.com

News

FDA Publishes Guidance on Physical–Chemical Identifiers
Last week, FDA published a final guidance for pharmaceutical manufacturers that plan to incorporate physical–chemical identifiers in solid oral dosage forms as an anticounterfeiting strategy. Click Here to Read More

Roche to Acquire Anadys Pharmaceuticals
Roche signed a definitive agreement to acquire Anadys Pharmaceuticals. The two companies have entered into a definitive merger agreement for Roche to fully acquire Anadys at a price of $3.70 per share in an all-cash transaction.
Click Here to Read More

Government Accountability Office Investigates Doctor Shopping
At the request of the US Senate Subcommittee on Federal Financial Management, Government Information, Federal Services, and International Security, the Government Accountability Office conducted an investigation into doctor shopping in Medicare Part D.
Click Here to Read More

SOCMA, PhRMA Welcome Passage of Free-Trade Pacts
The US Senate and House of Representatives passed last week three separate free-trade pacts with South Korea, Colombia, and Panama. The Society of Chemical Manufacturers and Affiliates and the Pharmaceutical Research and Manufacturers of America both issued statements expressing support for the legislation.
Click Here to Read More

Acino Acquires Cephalon's Middle East and African Business
Switzerland’s Acino Pharma has agreed to buy Cephalon’s combined Middle East and African business in a transaction worth approximately EUR 80 million ($110 million). Acino will pay EUR 60 million ($82.5 million) in cash and an additional EUR 20 million ($27.5 million) will come through shares.
Click Here to Read More


Product Spotlight

Production centrifuge offers large-scale separation for bioprocessing applications

Celeros’s Model APD-250 centrifuge was developed for large-scale solid–liquid separation applications for the bioprocessing industry. The centrifugal separator employs a tubular bowl with a working volume of 40 L. The unit is eight times larger than the company’s highest-capacity systems on the market, and can process bioreactor harvests of as much as 10,000 L in a single shift.

The APD-250 production centrifuge can generate as much as 20,000 × g of separating force. This feature helps the unit produce exceptionally dry paste and clear centrate for the biotechnology industry.

The Celeros APD-250 Centrifuge uses a patented Automatic Piston Discharge system to completely transfer separated solids from the bowl without operator intervention or excessive loss of centrate. It is equipped with a clean-in-place system and can be outfitted with various process components to meet the process standards required by cGMP-compliant production facilities.

Company Notes

The CRO BASi (Bioanalytical Systems) has renovated space at its preclinical toxicology site in Evansville, Indiana, and will relocate several research services to its facility at Purdue Research Park in West Lafayette, Indiana, creating several new positions. In addition, BASi also has added research instrumentation at its bioanalytical laboratories at three sites. The company is using some proceeds of a $5.5-million public offering in May 2011, to make capital improvements and purchase laboratory equipment. In addition, BASi is relocating its in vivo discovery services in 2012 to its West Lafayette facility. Several new positions will be created to staff the laboratories.

The Bristol-Myers Squibb Foundation has announced a collaboration with the World Health Organization’s Stop TB Department for a two-year pilot initiative to strengthen community-based prevention, care, and control of tuberculosis (TB), including coinfection with HIV in South Africa, Tanzania, Kenya, Ethiopia, and the Democratic Republic of the Congo. These five countries collectively represented more than 13% of global TB and more than one-third of the TB/HIV coinfection burden in 2009.

The CDMO DPT Laboratories has announced continued investments in its manufacturing facilities. Since completing $45 million in capacity expansion and equipment upgrades for its San Antonio, Texas, and Lakewood, New Jersey, facilities in mid-2010, DPT plans to invest another $14 million in the facilities. DPT will invest almost $4 million in additional upgrades to its compounding and packaging facilities, including a washroom expansion for capacity and process-flow improvements at its center for semisolids and liquids in San Antonio. Equipment upgrades over the next few months will include a new small-scale compounding suite with two new dissolvers, as well as new infrastructure to handle larger deliveries from suppliers to support increased production at the facility. After completing $30 million in expansions and upgrades at its sterile and specialty products facility in Lakewood last year, DPT will invest another $10 million in the facility. Equipment upgrades expected to be in place within the coming months include installation of a new small-volume parenteral filler that is designed to be fully automated, integrated, and isolated from vial wash through tray filling.

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Ligand Pharmaceuticals, a biotechnology company, has entered into a global licensing agreement with the biopharmaceutical company Chiva Pharmaceuticals for Fablyn (lasofoxifene), a selective estrogen receptor modulator for treating osteoporosis in postmenopausal women at increased risk of fracture. In return for the license, Ligand will receive $4 million in licensing payments over the next eight months and is also eligible to receive milestones and royalties on worldwide sales of Fablyn.

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US Senator Robert Menendez (D-NJ), New Jersey Lieutenant Governor Kim Guadagno, and regional leaders of the biopharmaceutical industry unveiled the new Cranbury, New Jersey, home of Oncobiologics a biotechnology firm. Earlier this month, the company signed two agreements. The first was with Parilis Biopharmaceuticals, an early-stage biotech company, and involves worldwide licensing for an undisclosed biotherapeutic product. The second is with an undisclosed US-based pharmaceutical company to conduct research focused on solving issues related to downstream processing of monoclonal antibodies. The combined value of the agreements to Oncobiologics totals approximately $80 million.

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The biopharmaceutical company Onyx Pharmaceuticals and Bayer HealthCare restructured their partnership for the global development and marketing of Nexavar (sorafenib) tablets and entered into a new agreement related to regorafenib, a late-stage oncology compound. Under the terms of the agreements, regorafenib is a Bayer compound, and Bayer will have the final decision-making authority for global development and commercialization. Onyx will receive a royalty on any future global net sales of regorafenib in oncology. In addition, Bayer will contract the Onyx sales force to promote regorafenib, along with Bayer sales representatives, in the US. The status of Nexavar under the revised collaboration agreement remains largely unchanged. Onyx and Bayer are free to use their respective Nexavar sales forces to promote regorafenib and additional products outside of the collaboration in the future. Bayer will purchase Onyx’s royalty rights for sales of the product in Japan in exchange for a one-time payment to Onyx. Bayer will have no obligation to pay Nexavar royalties to Onyx on Japanese sales after Dec. 31, 2011. Further, in the event of a change of control or acquisition of Onyx, the current profit-sharing, codevelopment, and US copromotion of Nexavar will be preserved.

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The biotechnology company GlycoMimetics has entered into an exclusive worldwide licensing agreement with Pfizer for the GlycoMimetics investigational compound GMI-1070. GMI-1070 is a pan-selectin antagonist currently in Phase II development for treating vaso-occlusive crisis associated with sickle-cell disease. GMI-1070 has received Orphan Drug and Fast Track status from FDA. The potential value of the agreement to GlycoMimetics is approximately $340 million, which includes an upfront payment, and development, regulatory, and commercial milestones.

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The CRO Quintiles has opened its new European headquarters in Reading, United Kingdom. The company will begin operations with employees from each of its clinical, commercial, consulting, and capital disciplines.

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The pharmaceutical company Servier and Hybrigenics, a French biopharmaceutical company, have signed a license and research collaboration agreement in the field of deubiquitinating enzymes (DUBs) applied to oncology, neurology, psychiatry, rheumatology, diabetes, and cardiovascular disease. Hybrigenics will identify and validate new targets among DUBs in these therapeutic areas. Hybrigenics will also screen potential therapeutic agents able to modulate four undisclosed targets, already chosen as exclusive DUBs of interest under the collaboration. Servier will provide the compounds to be screened, develop the selected compounds, and commercialize the approved drugs. Hybrigenics’s activities under this collaboration may also lead to the discovery of companion diagnostics, potentially needed for such therapeutic drugs. During the three years of collaboration, Hybrigenics will receive an upfront payment and research funding totaling EUR 4 million ($5.5 million). Depending on the achievement of predefined research, development, and registration milestones, Hybrigenics is further eligible to receive payments amounting to EUR 9.5 million ($13.1 million) for each target successfully leading to registration of a new drug and for royalties on sales of companion diagnostic kits.

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Teva Pharmaceutical Industries has completed its acquisition of the biopharmaceutical company Cephalon. The combined company has pro-forma sales of $20 billion for the 12 months ending June 2011.

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WuXi PharmaTech, a pharmaceutical and biotechnology services company, has acquired Abgent, a provider of biological research reagent products and services based in Suzhou, China, and San Diego, California. The acquisition of Abgent provides WuXi with development and production facilities, consisting of a 34,000-ft2 laboratory in Suzhou, and a 10,000-ft2 laboratory and office in San Diego.

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

Amgen has appointed Robert A. Bradway, president and chief operating officer, to the company’s board of directors. Bradway joined Amgen in 2006 as vice-president of operations strategy and served as executive vice-president and chief financial officer from April 2007 to May 2010.

The CMO AMRI has named Subramanyam Maddala as president of its India operations. Maddala will manage AMRI’s Indian API manufacturing operations as well as AMRI facility operations in Hyderabad and Aurangabad, India.

BASi has appointed John Devine, Jr., as vice-president of nonclinical services. Devine was previously general manager of BASi’s Evansville, Indiana, facility.

Covance, a drug-development services company, announced that Raymond Kaiser has joined the company as the new global science leader and vice-president for biotechnology services. Kaiser will replace Carl Martin, who will be retiring from this role, after 35 years with Covance.

Eli Lilly has announced appointments due to the Dec. 31, 2011 retirements of senior leaders, Bryce D. Carmine and Frank Deane. Dave Ricks, president of Lilly USA, is being promoted to succeed Bryce D. Carmine as senior vice-president and president of Lilly Bio-Medicines. Maria Crowe, senior vice-president for global drug-product manufacturing, is being promoted to succeed Frank Deane as president of manufacturing operations. Alex Azar, following Ricks’ promotion, is being promoted to president of Lilly USA. The new appointments will take effect on Jan. 1, 2012.

PharmTech, the magazine
Current Issue cover
Single-use Technologies in Fill–Finish Operations
By Amy Ritter
Single-use components in the fill–finish line provides increased flexibility to multiproduct manufacturers
Click Here to Read More

Coming soon: Pharm Tech's November issue features special coverage on drug delivery.

 

 

 

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