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Podcasts

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

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

Podcast: A Conversation with NIH Director Francis Collins

Events

3rd Annual Effective Business Development Outsourcing Relationships Conference
July 19–July 21, 2011
Philadelphia, PA

Pre-Filled Syringes Asia Pacific
July 20–July 21, 2011
Singapore

BioProcessing, Biologics & Biotherapeutics
July 20–July 21, 2011
Edinburgh, Scotland

World Cell Line Development & Scale Up Summit
July 26–July 28, 2011
London, United Kingdom

CoSMoS 2011
August 1–August 3, 2011
Chapel Hill, NC

Regulatory Affairs: Part I: The IND Phase and Part II: The NDA Phase
August 8–August 12, 2011
Boston, MA

More events


FindPharma Search
July 14, 2011 PharmTech.com

News

FDA Introduces Strategy to Combat Food Smuggling
FDA announced in early July 2011 that it has made progress toward implementing the US Food Safety Modernization Act, which was enacted in January of this year.
Click Here to Read More

SOCMA Offers Support for Free Trade Pacts with South Korea, Panama, and Colombia
SOCMA has issued its support this week of the passage of pending free-trade agreements with South Korea, Panama, and Colombia by two Congressional committees. Click Here to Read More

FDA Bans Import of Drugs from Dr. Reddy's Mexico Site
FDA banned the importation of products manufactured at the Mexican unit of Dr. Reddy's Laboratories. The import ban is a result of the company's failure to correct the violations listed in a recent Warning Letter to the agency's satisfaction. Click Here to Read More

The Economic Contribution of the US Biopharmacuetical Industry
Recent trends in the US biopharmaceutical industry suggest this is a pivotal area for potential job creation. Click Here to Read More

EMA Plans Public Access to Side-Effects Data
Members of the public will soon be able to access data in the EudraVigilance database—EMA's central repository for reports of suspected adverse reactions related to authorized medicines in the European Economic Area. Click Here to Read More


Product Spotlight

Pharmaceutically compliant machine packages solid-dose products

The modular Integrated Bottle Packaging Center 120 (IBC-120) from Uhlmann Packaging Systems is appropriate for all solid-dose products. The unit can package small- to medium-sized batches at a rate of 150 bottles/min, and can process round, rectangular, and oval bottles of 45–200 mm in height and 25–125 mm in diameter as well. Its compact, 5-m monoblock design performs essential functions for packaging solid-dose products in bottles. On average, the machine is 20% more efficient than line solutions composed of separate components.

The IBC-120's integrated packaging stations are controlled by a central touchscreen user interface. Operators can adjust the machine to new bottle heights by touching the screen. An infrared counting system provides 100% counting accuracy, and the machine's tablet counter can accommodate as many as four counting modules. A master shift register is designed to ensure product integrity and monitor the bottle discharge. An enclosed system ensures operator and product protection.

 
Company Notes

Bristol-Myers Squibb and Innate Pharma, a biopharmaceutical company, have formed a global agreement for the development and commercialization of IPH2102, an antibody in Phase I development for treating cancer. Under the agreement, Innate Pharma will grant to Bristol-Myers Squibb exclusive worldwide rights to develop, manufacture, and commercialize IPH2102 and related compounds blocking KIR receptors. The agreement covers all potential indications for IPH2102. Innate Pharma will continue to develop IPH2102 in acute myeloid leukemia through to the end of Phase II. Innate Pharma will also provide preclinical support for the development of IPH2102. Bristol-Myers Squibb will fund the development of IPH2102, make an upfront payment of $35 million, and provide additional payments of up to $430 million, depending on the achievement of prespecified milestones during the development and commercialization period, as well as prespecified tiered double-digit royalty payments on worldwide net sales.

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Janssen Pharmaceutica, a division of Johnson & Johnson’s (J&J) subsidiary Janssen Pharmaceutical Companies, has completed the divestiture of its animal-health business to Elanco, a division of Eli Lilly. Financial terms of the transaction were not disclosed. Under the transaction, Elanco acquires products, contracts, and related intellectual property and marketing authorizations. The terms of the offer also include that the employees, active in 11 different countries, transfer to Elanco.

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In other news, McNeil Consumer Healthcare, a division of J&J’s subsidiary McNeil-PPC, reported on June 28, 2011, that it is recalling at the retail level one product lot (60,912 bottles) of Tylenol, Extra Strength Caplets, 225 count bottles, distributed in the US. The recalled product was manufactured in February 2009. McNeil is taking this action following a small number reports citing the presence of a musty, moldy odor. The uncharacteristic odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole.

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UPS and Merck have extended their existing distribution and logistics agreement to include aspects of Merck’s global supply chain around the world. UPS currently manages the distribution, warehousing, and transportation of Merck’s medicines and vaccines in North America.

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Mylan has expanded its licensing agreement between Gilead Sciences and Mylan’s Matrix Laboratories. Matrix has licensed the rights to produce and market generic versions of three Gilead HIV/AIDS therapies, pending regulatory approval. The Gilead products, which are currently in late-stage clinical development, include: elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the “Quad,” a once-daily, single-tablet combination of four separate Gilead medicines.

The contract development and manufacturing organization Pharmalucence has selected Integrated Project Services to provide architectural design, engineering and construction of its aseptic manufacturing facility in Billerica, Massachusetts. Pharmalucence has initiated the first phase of its construction program to prepare for partial occupancy of the facility in late 2011. All phases of construction will be completed by mid-2012, with implementation of full drug manufacturing by mid-2013.

Pfizer has announced that it is exploring alternatives for its animal-health and nutrition businesses based on a recent business portfolio review to determine the optimal mix of businesses for maximizing shareholder value. The company is considering options that may include, among others, a full or partial separation of each of these businesses from Pfizer through a spinoff, sale, or other transaction. Given the separate and distinct nature of animal health and nutrition, the company may pursue a different alternative for each business.

Sanofi has agreed to divest its dermatology business, Dermik, to Valeant Pharmaceuticals International, a specialty pharmaceutical company for $425 million. Dermik's portfolio includes therapeutic and aesthetic dermatology brands such as BenzaClin for the treatment of acne, Carac for the treatment of keratoses, and Sculptra, a facial injectable for the treatment of facial wrinkles and folds. Also included in the divestment is Sanofi's Laval, Canada, site, which includes Dermik's manufacturing facility. Sanofi's Canadian affiliate, sanofi-aventis Canada, will maintain its operations in Canada. The deal is subject to customary closing conditions and regulatory approval.

Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to [email protected]

People Notes

Carbogen Amcis, a contract development and manufacturing organization, has named Mark C. Griffiths as CEO. In his new role, Griffiths will manage the company’s Swiss business and will report to Jay Vyas, managing director of Dishman Pharmaceuticals and Chemicals, Carbogen Amcis’ parent company.

The Department of Science and Technology of New Delhi, India, has awarded $1.5 million for a two-year period to K. Ruckmani, PhD, professor and head of the department of pharmaceutical technology at Anna University of Technology at Tiruchirappalli, India, to establish a national facility on drug development.

Eli Lilly has named its current senior vice-president of global quality, Fionnuala Walsh, to its executive committee. Walsh will report to John Lechleiter, chairman, president, and CEO of Lilly.

Merck Serono, a division of Merck KGaA, has made two appointments to its executive management team. Belén Garijo has been named as chief operating officer, effective Sept. 1, 2011, and Annalisa Jenkins has been named as global head of drug development and medical, effective Sept. 5, 2011.

Smithers Pharma Services, an analytical chemistry and formulation service provider, has appointed Prasad Raje, PhD, as president. Raje will report to Smithers’ group president and CEO Michael Hochschwender. Raje joined the Smithers organization in October 2009, and has served as executive vice-president of Smithers Viscient since February 2011.

PharmTech, the magazine
Current Issue cover
Calling the Shots: Innovation in Controlled-Release Injectables
By Erik Greb and Rich Whitworth
High demand could lead to innovation in controlled-release injectables.
Click Here to Read More



Coming soon: Look for our special ingredients report on APIs and excipients in the upcoming August issue.


PharmaFaceoff

The Challenges of Research & Development
Should pharma search for external drug candidates to refill the pipeline or develop internal R&D capabilities? Renee Cohen (vice-president of corporate strategy at Shire) and Ray Jupp (vice-president of the fibrosis and wound repair therapeutic strategy unit at Sanofi) join Barbara Ryan, Ken Kaitin, and Charlotte Sibley to debate how pharma can replenish its drug development pipeline in this Pharma Faceoff episode.
PharmaFaceoff

Sustainability at Work: Solar Energy
By Erik Greb
New Age Industries, a manufacturer of plastic molding and fittings for the pharmaceutical and biopharmaceutical industries, implements a solar-energy project at its Pennsylvania facility.Click Here to Read More
 

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