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Podcasts

Webcast: Protect and Legally Defend Your Scientific Intellectual Property: Digital Signatures Alone Aren't Enough
Mar. 31, 2011—Sponsored by Surety

Webcast: How to Optimize Outsourcing CMC Development and Manufacturing
On–Demand—Sponsored by Halo Pharmaceuticals

Webcast: The Future of Solid Dosage Manufacturing
On–Demand—Sponsored by Confab Laboratories

Webcast: Risk Management for Pharmaceutical Manufacturing and Equipment: Meeting Regulatory Expectations and Preventing Contamination
On-Demand—Sponsored by Alfa Laval

Podcast: A conversation with Jim Greenwood

Podcast: Interviews with AAPS 2010 Science Award Winners

Podcast: Thomas Otto on Vetter Secondary Packaging

Podcast: Lou Schmukler on Pfizer's Manufacturing Strategy

Events

Pittcon 2011
Mar. 13–18
Atlanta

DCAT Week 2011
Mar. 14–17
New York

SustaiNext 2011
Mar. 22–23
Philadelphia

Pharma Packaging and Labelling Compliance Conference
Mar. 23–25
Barcelona

Selecting and Managing CROs
Mar. 28–29
King of Prussia, PA

IVT’s 2nd Annual Validation Week EU
Mar. 28–30
Amsterdam

Pharma & Biotech Supply Chain World Asia
Mar. 29–31
Singapore

Interphex 2011
Mar. 29–31
New York City

More events


FindPharma Search
March 10, 2011 PharmTech.com

News

Hamburg Describes Efforts to Develop Medical Countermeasures
FDA Commissioner Margaret Hamburg stressed the importance of medical countermeasures for responding to natural and deliberate threats to public health.
Click Here to Read More

AstraZeneca Discontinues Pulmicort Production
AstraZeneca will discontinue the production of Pulmicort (budesonide) 100 and 200 µg/dose HFA (hydrofluoroalkane) pressurized metered-dose inhaler (pMDI) due to manufacturing issues related to technical aspects of the device. Click Here to Read More

Japan Halts Use of Pfizer and sanofi Vaccines
Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days. Click Here to Read More


Product Spotlight

Instrument enhances protein characterization

Malvern has introduced its Zetasizer µV SEC-LS instrument, which provides the capability of a sensitive size-exclusion chromatography (SEC)–light scattering detector, and that of a research-grade batch dynamic light-scattering system. The incorporation of light scattering into the device improves protein characterization by SEC because it eliminates the reliance on column calibration and the interference from unexpected sample-column interactions. Dynamic light scattering also enables fast screening for sample aggregates that may indicate formulation problems or batch contamination.

The instrument contains Malvern’s OmniFACE and OmniSEC software packages. The OmniFACE product enables operators to connect the instrument to third-party systems. Users thus can add light scattering to their SEC system’s capabilities without buying a new system. The OmniSEC software is designed to allow scientists to convert raw data to results quickly.

Operators can change the sensitive Zetasizer µV instrument from flow mode to batch mode in seconds. The device’s 8-µL flow cell is intended to virtually eliminate band broadening.

Company Notes

Contract research organization Advion plans to open a 22,000-ft2 drug-discovery bioanalytical laboratory to support Eli Lilly. The facility, expected to be operational by May 2011, will be located in the Purdue Research Park of Indianapolis's technology center at the Ameriplex Business Park.

Amatsi (formerly known as CRID Pharma) and Avogadro, two contract drug-development organizations, announced that they will combine to form the contract development and manufacturing organization Amatsi-Avogadro.

Biotechnology company Amyris formed a contract-manufacturing pact with the contract manufacturing organization Antibióticos under which Antibióticos will produce farnesene at its facilities in León, Spain. The produced farnesene will be owned and distributed by Amyris.

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Contract research organization Charles Rivers has partnered with Pfizer to provide certain Pfizer-developed genetically modified research models. Under the agreement, Charles River will supply a number of precompetitive, transgenic research models developed by Pfizer across therapeutic areas, such as neuroscience, diabetes, and cardiovascular disease.

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Contract research organization Covance received accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) for the company’s development research facility in Shanghai. The facility provides bioanalytical, toxicology, lead optimization toxicology, in-vivo pharmacokinetic screening, and metabolism services.

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Clondalkin Group, a producer of flexible and specialist packaging products, agreed to acquire the Printed Components business of Catalent Pharma Solutions. Terms of the transaction were not disclosed, and closing is subject to regulatory approval. In addition, Clondalkin and Catalent will enter into a long-term supply agreement.

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CSM Global Pharma, a joint venture between Cadila Pharma and the Holtzman Group, will invest $65 million in a pharmaceutical manufacturing facility in Kigali, Rwanda, in association with the Rwandan Development Board (RDB). The RDB said that the plant would manufacture solids, liquids, gels, ointments, creams, syrups, biologicals, injectables, vaccines, and active pharmaceutical ingredients. The facility is expected to be fully operational by 2015.

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GEA Pharma Systems, a provider of pharmaceutical processing solutions, signed an agency-representation agreement with Christian Berner Tech Trade, a technical trading company based in Oslo, to sell its range of GEA solid-dosage technologies throughout Sweden and Norway.

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Genzyme completed the sale of its pharmaceutical intermediates business to International Chemical Investors Group (ICIG). ICIG purchased substantially all of the pharmaceutical intermediates business, excluding the drug-delivery technologies portion. The acquired business has been renamed Corden Pharma Switzerland and will operate as part of ICIG’s pharmaceutical business within the Corden Pharma group platform of companies. Financial terms were not disclosed. The approximately 120 employees of the pharmaceutical intermediates business will remain employed with Corden Pharma, which plans to maintain operations at the business’s primary location, a manufacturing facility in Liestal, Switzerland. The company will also maintain a US sales and marketing office in Boston. As part of the agreement, Corden Pharma entered into a supply contract to provide Genzyme with materials needed for the production of eliglustat tartrate, an investigational treatment for Gaucher disease Type 1 that is currently in Phase III clinical trials.

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Genzyme’s board of directors unanimously recommended that shareholders accept the sanofi aventis revised tender offer to purchase all outstanding shares of Genzyme common stock for $74.00 and one contingent value right, per share. Sanofi extended the offer, which was previously scheduled to expire on Mar. 16, 2011, until Apr. 1, 2011.

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GlaxoSmithKline (GSK) outlined new plans to encourage students graduating from UK universities to consider pursuing a career within the company. Each year, GSK currently recruits between 50–100 undergraduate students from various academic disciplines into its UK Graduate Training Programs or other roles within the company. Successful applicants are already offered competitive compensation packages. GSK will reimburse certain tuition fees for all undergraduates recruited in the UK. These payments will be made upon the commencement of full employment and will be conditional on the employee remaining with the company for a minimum of two years.

Biopharmaceutical company GTx and the pharmaceutical company Ipsen have agreed to terminate their collaboration for the development and commercialization of toremifene. According to a press statement by GTx’s CEO, after studying the business case for toremifene 80 mg, the companies decided to terminate the collaboration.

Lycera, a biopharmaceutical company, entered into a drug-development pact with Merck & Co. focused on small molecules that target T-helper 17 (Th17) cells, key mediators of inflammation, with the aim of developing therapies for autoimmune diseases. Lycera will receive $12 million in upfront cash payments, significant committed research funding, and is eligible to receive up to $295 million in milestone payments, as well as royalties on product sales.

Marken, a provider of clinical-trial logistics and storage services, added a clinical-trial material supply depot in Singapore. The 14,500-ft2 facility offers a range of secured storage conditions and services, such as drug returns and destruction and kit building.

Ricerca Biosciences, a contract research organization, formed a pact with Fulcrum Pharma, an Aptiv Solutions company, a provider of drug-development consulting and regulatory services. The collaboration is designed to provide biopharmaceutical companies with an efficient process to move a candidate from development to clinical evaluation.

The University of California at San Francisco formed a two-year drug-delivery pact with Zcube, the research corporate venture arm of Italian pharmaceutical company Zambon. The agreement focuses on microtechnology and new ways to deliver oral medications to a targeted site in the body, particularly, to the small intestine and colon. According to a UCSF press release, the research will center on a microdevice that resembles a tiny, square Band-Aid with reservoirs in the middle for medication. Hundreds of these micropads would be packaged into a normal-sized pill, which would break down and release them into the intestine, where they would stick to the intestinal wall and deliver medications.

Contract research organization WuXi PharmaTech and Bristol-Myers Squibb formed a collaboration for a new stability-testing facility in Singapore. Under the agreement, WuXi will build, equip, and operate a CGMP-compliant 25,000-ft2 analytical testing facility to store and test stability samples and to perform other services for Bristol-Myers Squibb.

   

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

Allergan’s board of directors has reappointed David E.I. Pyott as president. Pyott will also continue in his current roles as chairman and CEO. Pyott’s role as president succeeds the duties performed by F. Michael Ball, who has accepted the position of CEO of Hospira, a specialty pharmaceutical company. Pyott will assume his new role on Mar. 27, 2011, the day of Ball’s departure from Allergan.

Cambridge Major Laboratories promoted Chief Business Officer Brian W. Scanlan to the positions of president and CEO. He replaces Michael Major, the company’s founder and CEO for the past 11 years, who has decided to retire.

Chemsultants International, a company focused on polymer-based products and technologies, named Jack Yeary as Quality Specialist. He will report to Cheryl Saqqa, testing project leader.

Gentium, a biopharmaceutical company, appointed Adrian Haigh senior vice-president of commercial operations. Haigh previously served as a regional vice-president of commercial operations for Biogen Idec

ISP Pharmaceuticals appointed Yunxia (Vivian) Bi technical director of the company’s Solubility Initiative. In the newly created position, she will oversee the development of technical data and information to support the use of ISP’s solubility-enhancing ingredient portfolio and solid-dispersion development services. Bi previously served as associate principal scientist at AstraZeneca Pharmaceuticals.

Rexahn Pharmaceuticals CEO Chang Ahn will give up his position and become the company’s chief science officer. He will continue to serve as chairman of the company’s board. Rexahn has initiated a search for a CEO to succeed Ahn and expects to appoint a successor by October 2011.

Regulatory Roundup

FDA posted last week the minutes to January 2011 meetings about renewing the Prescription Drug User Fee Act. Industry and regulators discussed cost and inflation measurements as well as small-business waivers. Read the full minutes of industry’s comments here: Jan. 25, 2011 and Jan. 20, 2011.

PharmTech, the magazine
Current Issue cover
PharmTech Bioprocessing Survey 2011
If you're involved in producing biopharmaceuticals, you are invited to take a few minutes to fill out PharmTech’s Bioprocessing Survey 2011. The survey is designed to obtain a snapshot of the state of the art in biopharmaceutical processing and manufacturing.
Click Here to Read More

Coming Soon: The upcoming cover story looks at parenteral drug manufacturing in the April issue of Pharmaceutical Technology.

 

 
 
 
 
 
 
 
 
 

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