| October 23, 2012 |
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| News |
New USP Standards Guide Prescription Container Labels
Jennifer Markarian
New US Pharmacopeial Convention standards provide a universal approach to organizing labels for prescription containers dispensed by US pharmacists in an effort to improve patient understanding.
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GSK Encourages Open Innovation and R&D
Stephanie Sutton
GlaxoSmithKline has outlined the measures it is taking as part of a new open innovation approach to R&D, including opening up its tuberculosis compound library, investing in its open laboratory in Spain, and sharing detailed clinical trial data with researchers.
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Grad Student Research Sparks Innovation through AAPS Awards
Angie Drakulich
At last week’s AAPS 2012 Annual Meeting in Chicago, graduate students across the country were honored for their research and work in bio/pharmaceutical innovation. BioPharm International had the chance to talk with a few of the recipients.
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| Basic Training |
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Basic Training: Meeting Challenges for Analysis of Antibody-Drug Conjugates
The complex structure of ADCs necessitates different analytical strategies than those for either small molecules or unconjugated monoclonal antibodies.
View more Basic Training in Drug Development and Manufacture guides
Get more free content like this by subscribing to BioPharm International: www.biopharminternational.com/enewssignup. |
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| Discovery Pipeline |
Efficient Direct Reprogramming of Mature Amniotic Cells into Endothelial Cells by ETS Factors and TGFß Suppression
A method for creating vascular endothelial cells, which are cells that line the interior of blood vessels, out of cells obtained from human amniotic fluid is described. The authors show that these cells can form blood vessels when transplanted into mice, and suggest that human amniotic cells may be a promising source to produce tissue for treatment of vascular disorders. (Cell)
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Methylation Subtypes and Large-Scale Epigenetic Alterations in Gastric Cancer
Researchers identified subtypes of gastric cancer by surveying DNA methylation in 240 distinct tumors. They found heterogeneity in methylation patterns, including one group of tumors with very high methlyation levels that were associated with a poor prognosis. The authors conclude that gastric cancer is a conglomerate of multiple diseases, each with a different underlying biology and hallmark features, and that individualized diagnosis and therapy will be necessary for effective treatment. (Science Translational Medicine)
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| Industry Briefs |
| Catalent Pharma Solutions has taken an exclusive license to taste-masking technology developed by the New Jersey Institute of Technology. Under the terms of the license, Catalent will complete transfer of the technology into its cGMP facilities to support manufacture of dosage forms such as its Zydis fast-dissolve platform. Read More |
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| On Sept. 20, 2012, an investigator from FDA visited MicroConstants’ San Diego, California, facility for a routine inspection to assess the CRO’s overall compliance with good laboratory practice regulations. During the visit, the investigator toured the facility and laboratory areas and reviewed several method validations, three sample analysis projects, and a pharmacokinetic analysis report. Upon completion of the inspection, the investigator reported zero findings, observations, or recommendations. Read More |
| Recipharm and Astimex Pharma have announced the formation of a collaboration agreement for the development and manufacture of a pharmaceutical product. The formulation development work will take place at the Recipharm Pharmaceutical Development site in Solna, Sweden. Astimex Pharma also has the opportunity to choose Recipharm as the future manufacturer for the product. Additionally, Astimex is in discussions with Recipharm for engagement to carry out other manufacturing and development contractual projects. Read More |
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| In other news |
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| Amgen has appointed Cynthia Patton as senior vice-president and chief compliance officer. Read More |
| Paladin Labs has entered into a licensing agreement with QRxPharma whereby Paladin received the exclusive rights to market and sell Moxduo, for treating acute pain, in Canada. Read More |
| Sirona Biochem has named Neil Belenkie as CEO. Read More |
| Theravance and Merck & Co. have agreed to discover, develop, and commercialize small-molecule therapeutics directed toward a target being investigated for treating of hypertension and heart failure. Read More |
| Unilife has expanded its commercial development team with the appointment of four senior executives. Read More |
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Biopharm International
The Magazine |
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Correlating Product Lifecycle and Manufacturing Site Characteristics with Product Deviations.
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Coming soon!
BioPharm's November issue will contain a peer-reviewed article on the evaluation of single-use fluidized bed centrifuge system for mammalian cell harvesting.
www.BiopharmInternational.com
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From the Editors of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International
| Jobs |
Vice President of Scientific Affairs
Washington, DC
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| Events |
November 12–14, 2012: BIO-Europe 2012—18th Annual International Partnering Conference
Hamburg, Germany
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November 13–14, 2012: PDA FDA Pharmaceutical Supply Chain Conference
Bethesda, MD
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November 15–16, 2012: 2012 Pharmaceutical Cold Chain & Good Distribution Practice Conference
Bethesda, MD
Registration details |
November 26–28, 2012: World Drug Manufacturing 2012
Dusseldorf, Germany
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December 3–4, 2012: Early Drug Development Summit 2012
Berlin, Germany
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