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 Small connectors offer many input–output points
High-density M12 connectors from Phoenix Contact (Middletown, PA) are available in 12- and 17-pole versions and offer more input–output points than traditional M12 sensor-actuator connectors. The connectors have a diameter of 11 mm and are appropriate for applications in which space must be conserved.
The connectors include the SPEEDCON technology that enables users to connect and disconnect with a quarter turn of the coupling nut. This technology saves time and ensures watertight connections.
Phoenix Contact’s M12 connectors are appropriate for process monitoring and control. The connectors and cordsets are suitable for applications such as robotics and machine-vision systems. The connectors provide an electrical connection for control or enable a programmable logic control to communicate with a piece of equipment. The products are available as printed circuit-board-mounted connectors, panel feed-through style connectors, and molded cordsets.
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Antibioticos do Brasil (ABL, Saõ Paulo, Brazil), a manufacturer of sterile active pharmaceutical ingredients (APIs) and finished dosage products, received a Warning Letter from FDA stating that the company did not adequately address good manufacturing practice (GMP) deficiencies at its Saõ Paulo, Brazil, site. FDA’s letter, dated July 24, 2009, states that current GMP deviations still remain after three response letters and three corrective action updates following the agency’s inspection of its facility in October and November 2008.
The biopharmaceutical company Cellceutix (Beverly, MA) signed an agreement with Girindus America (Cincinnati, OH), for the manufacture of Kevetrin active pharmaceutical ingredient. Terms of the agreement were not disclosed.
Forest Laboratories (New York) and AstraZeneca (London) will collaborate to develop and commercialize Forest’s anti-infective ceftaroline in all markets outside the United States, Canada, and Japan. AstraZeneca will pay Forest an undisclosed signing fee, sales-related royalties and milestone payments. Further financial terms were not disclosed. Forest expects to file a new drug application in the United States by the end of 2009, and AstraZeneca expects to file a marketing authorization application in Europe by the end of 2010, according to a Forest press release.
Gilead Sciences (Foster City, CA) announced in a press release that it received a subpoena from the Office of the Inspector General of the Department of Health and Human Services requesting documents regarding the development, marketing, and sales of Ranexa (ranolazine). Ranexa is approved for the treatment of chronic angina and was developed and originally commercialized by CV Therapeutics, a company that Gilead acquired in April 2009.
President Bill Clinton, on behalf of the Clinton Foundation, announced agreements with Mylan and Pfizer to lower prices medicines for patients with drug-resistant HIV in developing countries. A second-line regimen of four of Mylan’s antiretroviral (ARV) therapies, atazanavir, ritonavir, tenofovir, and lamivudine, will be available for under $500 annually. An agreement with Pfizer for rifabutin, a drug used to treat tuberculosis in patients taking second-line ARVs, reduced the price by 60% to $1 per dose.
Biopharmaceutical company Inovio Biomedical (San Diego, CA) entered into a research collaboration agreement with the National Institutes of Health’s Vaccine Research Center (VRC) to develop influenza vaccines. VRC and Inovio will develop universal influenza vaccines as well as advance development of vaccine candidates targeting the emerging pandemic 2009 H1N1 swine flu strains.
NeuroSearch (Ballerup, Denmark) and Johnson & Johnson’s Janssen Pharmaceutica (Beerse, Belgium) signed a drug-discovery and drug-development agreement to discover, develop, and commercialize new medicines to treat various central nervous system diseases. The agreement will run for three years with an option for Janssen to extend the alliance up to two years with additional funding to NeuroSearch.
Schering-Plough (Kenilworth, NJ) announced an agreement with Orchid Chemicals & Pharmaceuticals (Chennai, Tamil Nadu, India), related to the generic manufacturing of certain formulations of Clarinex (desloratadine). The agreement resolves all pending patent infringement litigation filed by Schering against Orchid and will allow Orchid to introduce a generic version of the Clarinex brand Reditabs (orally-disintegrating tablets) to be introduced into the US market on Jan. 1, 2012, and Clarinex brand 5 mg tablets to be introduced on July 1, 2012. Schering holds various patents related to Clarinex that extend to 2022.
SynCo Bio Partners (Amsterdam, The Netherlands), a biopharmaceutical contract manufacturer, signed a manufacturing supply pact with Versartis (Redwood City, CA), to produce Versartis’ lead drug candidate VRS-859, a novel GLP-1 analog for monthly dosing to treat Type 2 diabetes. Under the agreement, SynCo will develop and optimize the existing production process for VRS-859.
Contract development and manufacturing organization UPM (Baltimore, MD) announced that on June 4, 2009, FDA submitted a recommendation of approval to the Center for Drug Evaluation and Research for the company to manufacture a low-dose tablet product. The recommendation was the result of an FDA preapproval inspection of the facility and the manufacturing process for a new drug application for one of UPM’s clients.
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The US Food and Drug Administration has approved Schering Plough’s (Kenilworth, NJ) Saphris tablets (asenapine) to treat adults with schizophrenia and to treat bipolar I disorder in adults. The efficacy of Saphris in treating schizophrenia was studied in three short-term placebo-controlled and active-drug controlled clinical trials. In two of the trials, Saphris demonstrated superior efficacy compared with a placebo in reducing the symptoms of schizophrenia, according to an FDA press release.
Watson Pharmaceuticals (Morristown, NJ), a specialty pharmaceutical company, announced that one lot of 100 mcg/hr Fentanyl Transdermal System patches sold in the United States is being voluntarily recalled from wholesalers and pharmacies. A small number of patches leaking fentanyl gel have been detected in the recalled lot, potentially exposing patients or caregivers directly to fentanyl gel. Details about the recall can be found in the company press release.
Wyeth Pharmaceuticals (Collegeville, PA), a division of Wyeth, was alerted by the US Food and Drug Administration that the agency’s review of the biologics license application for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) has been extended from Sept. 30, 2009, to Dec. 30, 2009. In response to an FDA request, Wyeth submitted in late July additional analytical method validation and specification information relating to physical and chemical properties of the product. FDA considered this to be a major amendment and, as a result, extended the review cycle for Prevnar 13 by 90 days.
XCELERON (Germantown, MD), a provider of ultrasensitive bioanalytical studies supporting clinical research, signed a second master service agreement with GlaxoSmithKline (GSK, London). Xceleron will provide analytical support to GSK and its affiliated research organizations and will increase capacity through the acquisition of an accelerator mass spectrometry instrument.
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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The US Food and Drug Administration is reorganizing the Office of the Commissioner (OC), according to an Aug. 18 Federal Register announcement. Being realigned are four Deputy-level offices: the Office of the Chief Scientist; the Office of Administration (formerly titled the Office of Operations); the Office of Foods; and the Office of Policy, Planning and Budget (formerly titled the Office of Policy, Planning and Preparedness). Read the full details.
FDA also announced in the Aug. 18 Federal Register an extension of the public period for its transparency initiative. FDA’s Transparency Task Force is looking for industry’s feedback on ways it can be more open about agency activities and expectations. Comments can now be submitted through Nov. 6, 2009. Industry can also provide comments through the agency’s transparency blog.
FDA published two rules on Aug. 12 to “clarify the methods available to seriously ill patients interested in gaining access to investigational drugs and biologics when they are not eligible to participate in a clinical trial and don’t have other satisfactory treatment options.” The new rules focus on expanded access to and charging patients for investigational drugs, ultimately making these experimental drugs more widely available to patients by clarifying procedures and standards and by clarifying the specific circumstances, acceptable costs, and procedures for the manufacturer. FDA also plans to launch a website to help patients and healthcare professionals learn about investigational drug options including how to gain access to an investigational drug. The idea is to allow patients who may need these drugs but do not wish to or cannot enroll in clinical trials to gain access to them.
FDA published as draft guidances the Step 3 version of two ICH Annexes (Annex 9 and Annex 10) to Q4B in the Aug 14 Federal Register. The Annexes address the Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter and the Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter. The annexes reached Step 3 (regulatory discussion and consultation among the ICH parties) in June 2009. Annex 9 recommends that the analytical procedures described in the official pharmacopoeial texts for the US (Tablet Friability), Europe (Friability of Uncoated Tablets), and Japan (Tablet Friability Test), and USP can be used interchangeabley in the ICH regions. For interchangeability, the text adds that “the loss of mass for a single determination should be not more than 1.0%, unless otherwise specified in the dossier. When three determinations 116 are conducted, then the mean loss of mass for the three determinations should be not more than 1.%, unless otherwise specified in the dossier.” Annex 10 states that the pharmacopeial texts from the US (biotechnology-dereced articles: polyacrylamide gel electrophoresis), Japan (SDS–Polyacrylamide gel electrophoresis), and Euorpe (sodium dodecyl suplphate polyacrylamide gel electrophoresis) can be used interchanably in the ICH regions. Comments on both draft guidances are due Oct. 13, 2009.
The European Medicines Agency (EMEA) is now putting a schedule and format requirement on industry requests for compliance advice. Beginning Oct. 12, 2009 for companies who have not yet had a presubmission meeting and Oct. 19 who have had a presubmission meeting, the agency will only accept electronic submissions for scientific advice and protocol assistance requests, according to the EMEA website. Applications should be submitted only on a CD or DVD. Companies typically make these types of requests when there is not enough detail in existing European guidelines or monographs.
EMEA issued updated treatment recommendations to deal with the supply shortage of Cerezyme (imiglucerase for injection) in a press release. As reported in last week’s ePT, the Cerezyme shortage stems from a viral contamination at Genzyme’s manufacturing facility in Alston Landing, Massachusetts. |
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Absorption Systems (Exton, PA), a provider of bioanalytical capabilities and preclinical formulation services, named Sarath Kanekal, a veterinarian and board-certified toxicologist, vice-president of pharmacology and toxicology. Kanekal will oversee all technical staff at Perry Scientific, the company’s in vivo toxicology and pharmacokinetics facility located in San Diego, California.
Alder Biopharmaceuticals (Bothell, WA), an emerging antibody-therapeutics company, appointed Mark D. Young senior vice-president of pharmaceutical operations.Young previously worked at several biotechnology companies, including Zymogenetics (Seattle, WA) and Biomira (now Oncothyreon, Seattle, WA).
Constellation Pharmaceuticals (Cambridge, MA), a biopharmaceutical company, appointed Mark A. Goldsmith CEO and director. Goldsmith has held senior positions in academia and the biotechnology industry and was recently senior executive-in-residence at the healthcare venture-capital firm Prospect Venture Partners.
Robert J. Capetola resigned as President, CEO, and as a director of Discovery Laboratories (Warrington, PA), a biotechnology company. W. Thomas Amick, chairman of the board since March 2007, was appointed interim CEO.
Nancy Wysenski resigned as chief operating officer of the specialty pharmaceutical company Endo Pharmaceuticals (Chadds Ford, PA) to attend to family matters. Wysenski’s resignation will take effect Sept. 1, 2009. The company has engaged an executive search firm to assist in the search for a new chief operating officer.
ImmunoGen (Waltham, MA), a biopharmaceutical company that develops targeted anticancer therapeutics, appointed Peter Williams vice-president of business development. Williams was previously senior director of business development at Alnylam Pharmaceuticals (Cambridge, MA).
Millipore (Billerica, MA), a provider of technologies, tools, and services, appointed John Sweeney vice-president of Millipore’s life-science business. Most recently, Sweeney served as vice-president of strategy and marketing services for the company’s bioscience division.
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| Managing the Clinical-Trial-Materials Supply Chain |
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| Patricia Van Arnum |
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Collaborative planning and execution among clinical research, clinical operations, and supply-chain managers are key elements in effectively managing an increasingly complex and global supply chain for clinical trial materials.
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FDA’s Enforcement Plan
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