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 Incubators offer thermal protection
Caron’s GelJacket benchtop carbon-dioxide incubators incorporate an active insulation gel designed to offer a high level of thermal protection. The GelJacket insulation has a volumetric heat capacity 40 times greater than that of water, according to the company. This characteristic helps the insulation maintain the incubator’s temperature effectively when its door is opened or power is lost. The gel is sealed within the incubator, thus reducing the risk of leakage.
Unlike water-jacket incubators, which require manual cleaning, the GelJacket incubators withstand high temperatures and offer an automatic, 90 °C, moist-heat decontamination cycle. The incubators’ decontamination cycle is designed for easy use, and it cleans the units overnight.
Refrigerated and nonrefrigerated versions of the GelJacket incubator are available. The refrigerated unit has a standard temperature range of 5–60 °C for applications in which the heat generated by culturing techniques must be removed. The incubators include an infrared sensor that helps to maintain carbon-dioxide levels.
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Alexion Pharmaceuticals, a biopharmaceutical company, acquired Taligen Therapeutics, a development-stage biotechnology company, for $111 million in cash. Additionaly, Alexion will pay Taligen development and regulatory milestone payments for up to six products in the United States and European Union.
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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.
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Arena Pharmaceuticals will reduce its US workforce by approximately 25%, or 66 employees, by March 28, 2011. The company said in a statement that it will focus its resources on working to obtain regulatory approval of its obesity drug lorcaserin, seeking collaborators for the commercialization of lorcaserin outside of the US, and advancing select earlier-stage research and development programs independently or in partnership.
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Contract Manufacturing and Packaging for Solid Oral Dosage
Ropack, a leader in packaging solutions for the pharmaceutical, biopharmaceutical and nutraceutical industries, now provides the technology and expertise for stickpack packaging of solid oral dosage in a low relative humidity and temperature-controlled environment. Stickpacks – slim, tube-shaped packets the size of a stick of gum – offer impressive benefits: fill accuracy, portability, reduction in paper and foil usage, product differentiation and ideal sample option.
 http://www.ropack.com/en/service/primary-packaging/stick-pack |
Bristol-Myers Squibb and sanofi aventis received from FDA an additional six-month period of exclusivity to market Plavix (clopidogrel bisulfate) based on receiving pediatric exclusivity. Exclusivity for the drug in the US is now scheduled to expire on May 17, 2012.
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Successful EU GMP Inspection Management
Bethesda Marriott Hotel, Bethesda, MD
March 8-10, 2011
Course Fee: $2675 or $2140 (8 week advance or 2nd person)
This NSF-DBA interactive course provides an overview of European pharmaceutical legislation and key GMP differences between the US and the EU. You will learn how a European inspection differs from the typical FDA inspection and what the European inspector is likely to be looking for and how to prepare for the best results. Topics covered include inspecting logistics, preparing employees, interacting with the inspector and how to manage that all important meeting close.
Ideal for people interested in the legislative side of the Pharmaceutical business in US & EU.
Presented by Liz Allanson, formerly with the MHRA and responsible for training MHRA inspectors, together with Karen Migliaccio, formerly at Pfizer.  Read more |
Catalent Pharma Solutions, a provider of development, technology, and manufacturing services, entered into an agreement with Nuron Biotech for the formulation and supply of NU100 (interferon beta-1b), a recombinant human interferon beta compound being developed for the treatment of multiple sclerosis. Catalent will produce NU100 at its facility in Brussels, Belgium, where the product will be formulated, filled, and packaged in a prefilled syringe. Nuron Biotech plans to begin Phase III clinical trials of NU100 in 2011.
EMD Millipore, the life science division of Merck KGaA of Germany, formed an agreement with Novo Nordisk to transfer the distribution of recombinant human insulin for cell-culture media to Novo Nordisk. Starting on May 1, 2011, recombinant human insulin products for cell-culture media applications, branded by EMD Millipore as Incelligent SG and Incelligent AF, will be supplied directly from the manufacturer, Novo Nordisk.
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Reports from the Waters Bioanalysis World Tour:
At APA and AAPS last year, Waters gathered some of the brightest minds in bioanalysis to discuss the impact and opportunities made available with recent advances in LC/MS technologies. Read reports from these special events written by the Bioanalysis Journal and look for future symposia dates.
 waters.com/biotour |
Endo Pharmaceuticals formed an oncology drug-development pact with Orion, a pharmaceutical and diagnostic company. The collaboration enables the companies to develop eight "discovery phase" candidates by combining an equal number of programs. In addition, under the agreement both companies can exclusively license the others' development-ready programs at predetermined stages and share all development costs.
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Single-use filling solutions designed to grow with your product. Systems are available for lab through high-speed production. PreVAS is the most complete solution available including bags, tubing, connectors, pumps and filling needles preassembled, presterilized and ready to use. Systems are now available with both peristaltic and rolling diaphragm pumps.
 Click for more information… |
Genzyme will allow sanofi aventis to conduct due diligence in consideration of sanofi aventis' bid to acquire Genzyme. A company statement said that discussions between the companies are ongoing, but that Genzyme can provide “no assurance” that the discussions will result in any particular transaction.
GlaxoSmithKline and Actelion discontinued the clinical development of the Phase III investigational dual orexin receptor antagonist, almorexant. The decision follows a review of data from additional clinical studies, which were conducted to further establish the clinical profile of almorexant, including the tolerability profile, according to a company press release.
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World’s Only No Compromise UHPLC
At 19,000 psi, Shimadzu’s modular Nexera meets all analysis requirements: conventional, ultra-high speed, high resolution, high temperature, green, multidimensional, etc. with no compromise in data integrity. Features include the world’s fastest injection (10-second cycle time), near-zero carryover (0.0015% without rinsing), maximum resolution with the widest pressure/flow range (130MPa up to 3mL/min), and excellent injection reproducibility (0.25% area %RSD).
 Learn more |
H3 Biomedicine, a new biopharmaceutical company focused on personalized medicine, launched research and development operations. Pharmaceutical company Eisai has pledged up to $200 million in research funding to H3 Biomedicine, as well as additional clinical-development support. See a related blog post on PharmTech Talk.
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It’s all about the science that distinguishes Aptuit as the most complete global API provider. It’s about getting the API right the first time, every time and recognizing the critical impact the API has on everything needed to launch breakthrough drug products. Come to Informex Booth 1242 to speak to Aptuit professionals. Visit  www.aptuit.com to learn more. |
Johnson & Johnson and the biopharmaceutical company Crucell received approval of J&J’s proposed acquisition of Crucell from the European Commission. A company statement detailed the remaining timetable of the offer process, which includes a Feb. 8, 2011, offer extraordinary general meeting, and a Feb. 16 acceptance closing time.
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Improve Patient Adherence – Enhance Anti-counterfeiting Techniques – Comply with Global Serialization standards Join industry thought leaders to discuss the current trends in new package designs being implemented, strategies for anti-counterfeiting and tactics to increase adherence. Trust the experts — Register today at  www.cbinet.com/packaging and save $400 with promo code TGZ748! |
Pfizer completed its tender offer for all outstanding shares of common stock of King Pharmaceuticals at a purchase price of $14.25 per share. The shares validly tendered and not validly withdrawn represent approximately 92.5% of the outstanding shares of King common stock. Pfizer intends to complete the acquisition of King through a short-form merger on or about February 28, 2011, and King will become a wholly owned subsidiary of Pfizer.
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IVT’s 9th Annual Change Control — January 24-26, San Francisco
IVT’s Quality Risk Management — January 26-28, San Francisco Don't miss the opportunity to optimize your training by attending these back-to-back quality systems events that are a major FDA-focus. Learn to develop, implement and maintain a quality compliance program for two critical concepts — Change Control and Risk Management. Register for one or both events today at
 www.ivtevents.com |
Pfizer will close its research and development (R&D) facility in Sandwich, UK, the company said in its fourth-quarter report. The Sandwich facility conducts research in the therapeutic areas of allergy and respiratory disease. Additional changes to Pfizer’s R&D operations include shifting selected resources from its Groton, Connecticut, plant to Cambridge, Massachusetts, and outsourcing certain functions. Pfizer plans to enhance its presence in Cambridge, UK, and in the US in Cambridge, New York, San Francisco and La Jolla, California.
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Thousands of pharmaceutical, biologic, generic, and contract services professionals gather annually at INTERPHEX (March 29-31, 2011, Javits Convention Center, New York City) to see new products, network, and learn about emerging trends surrounding drug manufacturing. At INTERPHEX 2011, you’ll find the solutions and education you need to ensure quality, improve efficiency, and solve your manufacturing and supply chain problems. Register for a free exhibit hall pass at
 www.INTERPHEX.com |
Seven major research-based medical centers in New York City, including Rockefeller University, NYU Langone Medical Center, Memorial Sloan-Kettering Cancer Center, The Mount Sinai Medical Center, Columbia University Medical Center, Albert Einstein College of Medicine of Yeshiva University, and Weill Cornell Medical College, have joined Pfizer’s Centers for Therapeutic Innovation, a network of partnerships that aims to speed the translation of biomedical research into medicines. The first Center was established in November of last year at the University of California, San Francisco.
sanofi aventis and its US consumer healthcare division, Chattem, received FDA approval for the over-the-counter use in adults and children two years of age and older of the Allegra (fexofenadine HCl) family of allergy medication products. The drug will be available without a prescription in March 2011.
Tibotec Pharmaceuticals, part of Johnson & Johson, granted licenses to generic-drug manufacturers, including Hetero Drugs, Matrix Laboratories (a Mylan company), and Aspen Pharmacare, to manufacture, market, and distribute the investigational non-nucleoside reverse transcriptase inhibitor rilpivirine hydrochloride (TMC278), pending its approval for use with other antiretroviral agents in the treatment of treatment-naïve HIV-1-infected adults. Under the agreement, the generic-drug manufacturers will be entitled to manufacture once-daily 25 mg TMC278 as a single agent medicine and a fixed-dose combination (FDC) product.
The recall of Triad brand alcohol prep pads due to possible contamination prompted pharmaceutical manufacturers to issue statements about their products packaged with the affected pads. Pfizer and Progenics Pharmaceuticals advised customers not to use the Triad pads packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) subcutaneous injection in the US. Merck issued a similar warning about the recalled pads to customers who use Pegintron (peginterferon alfa-2b) single dose RediPen and Pegintron vials for markets in Europe, Asia Pacific (excluding Japan), Latin America and Canada, and Intron A (interferon alfa-2b) Multidose RediPen and Intron A solution vials for markets in Europe, Asia Pacific (excluding Japan) and Latin America. Merck medicines distributed in the United States are not impacted by the Triad Group recall.
Do you have news to report on facility expansions, contracts, service agreements, mergers, acquisitions, or personnel appointments? Send press releases to ptpress@advanstar.com |
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Contract manufacturing organization AMRI appointed Takeshi Yura assistant director of medicinal chemistry. Yura will report to Managing Director Raymond Yeung at the company's drug-discovery services operations in Singapore.
E. Morrey Atkinson joined Cook Pharmica as vice-president of research and development and chief scientific officer. He was previously head of biotechnology manufacturing sciences and technology at Eli Lilly.
Delenex Therapeutics, a biotechnology company, appointed Eric de La Fortelle as its CEO and Jakob Schlapbach as its CFO.
Susan Schniepp, vice-president of quality at OSO BioPharmaceuticals Manufacturing has been elected to the board of directors at the Parenteral Drug Association. Schniepp also is a member of Pharmaceutical Technology’s editorial advisory board.
Pfizer appointed Yvonne Greenstreet senior vice-president and head of medicines development for its specialty-care business unit. Greenstreet succeeds Michael Berelowitz, who is retiring. Greenstreet will report directly to Geno Germano, president and general manager of Pfizer’s specialty-care business unit.
Global specialty biopharmaceutical company Shire appointed Emmanuel Chantelot, former executive director of European Biopharmaceutical Enterprises, as director of European government relations and public policy.
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FDA will hold its fourth orphan-drug designation workshop for academics, biotechnology companies, and those unfamiliar with the orhan-drug designation process Feb. 28–Mar. 1, 2011, in Claremont, California, in collaboration with Keck Graduate Institute, according to an agency announcement. The workshop will focus on the process used by FDA to grant orphan-drug designation to drug products intended to treat rare diseases. Three similar workshops were held in 2010.
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Outsourcing Levels
How would you describe the level of outsourcing for active pharmaceutical ingredients or pharmaceutical chemical development services?
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