Melanie Sena is community editor of Pharmaceutical Technology.

Melanie Sena

The new ACQUITY QDa Detector from Waters is compatible with ACQUITY UPLC, ACQUITY UPC2,  HPLC, supercritical fluid chromatography, and LC-based purification systems. The on/off feature fully automates sample analysis and eliminates sample-specific adjustments for certainty in sample results, from user to user and system to system. The ACQUITY QDa Detector complements optical detection by confirming the identity of compounds with mass spectral information. Additionally, the ACQUITY QDa Detector extends the limits of sample detection for a chromatographic separation by quantifying compounds having no UV response or that are present at levels not detectable and quantifiable by optical detection. The ACQUITY QDa Detector is available for separations systems running Empower 2 & 3 Chromatography Data System software.

Articles

ACQUITY QDa Detector Increases Productivity

 has launched  'Perspectives – Art, Inflammation and Me', an initiative designed to add a different dimension to the current understanding of immune-mediated inflammatory diseases and their impact on patients and society. More than 100 artistic expressions from the initiative debuted at the 9th Congress of theEuropean Crohn's and Colitis Organization in Copenhagen, Denmark from Feb. 20-22.

The initiative involves more than 200 artists from 40 countries around the world. In addition to professional and independent artists, Perspectives included art studentsfrom more than 15 universities in France, Canada, Italy, and Spain through collaborations with the Polytechnic University of Valencia (Universitat Politecnica de Valencia).

The artistic expressions include, but are not limited to, sculptures, photographs, paintings, and installations. Perspectives will visit various art galleries and medical conferences throughout the world, with additional exhibition dates and locations to be announced.

AbbVie launches art initiative designed to explore impact of chronic inflammatory diseases.

Inflammatory Diseases Explained in Artistic Designs

 and 3D Imaging reported the arrival of the cyclotron, a particle accelerator, at its new Translational Imaging Center in Mattawan, Michigan. The radioisotopes produced from the cyclotron will be used to visualize, characterize, and quantify biological, chemical, and physiological processes at the cellular and molecular level 

. The cyclotron expands the portfolio of available radioisotopes that can be used in molecular imaging and provides drug developers a way to track drugs.

Products from the cyclotron will become commercially available when the Translational Imaging Center opens in May 2014.

The cyclotron is key component of MPI Research's Translational Imaging Center in Mattawan, Michigan.

Cyclotron Arrival at MPI Research's Translational Imaging Center

 approved orphan drug Myalept (metreleptin for injection), which is indicated as an adjunct to diet as replacement therapy for the treatment of complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Myalept, a recombinant analogue of human leptin, is the first and only treatment approved by the FDA for these patients.

AstraZeneca is working to complete the transfer of the Biologics License Application for Myalept from Bristol-Myers Squibb to AstraZeneca as part of the acquisition of the diabetes alliance assets, including Myalept and Amylin Pharmaceuticals, which was completed on February 1, 2014.

The safety and effectiveness of Myalept for the treatment of complications of partial lipodystrophy or for the treatment of liver disease, including non-alcoholic steatohepatitis, have not been established. Myalept is not indicated for use in patients with HIV-related lipodystrophy or for use in patients with metabolic disease, including diabetes mellitus and hypertriglyceridaemia, without concurrent evidence of congenital or acquired generalized lipodystrophy.

Myalept is for subcutaneous injection only and is available in an 11.3 mg vial that requires reconstitution.

The FDA is requiring seven studies (post-marketing requirements) for Myalept, including a long-term prospective observational study (product exposure registry) of patients treated with Myalept, a study to assess for the immunogenicity (antibody formation) of Myalept, and an assessment and analysis of spontaneous reports of potential serious risks related to the use of Myalept. Eight additional studies are being requested as post-marketing commitments.

FDA approves the orphan drug Myalept for the treatment of leptin deficiency.

FDA Approves Orphan Drug Myalept

 announced a call for submissions for its Life Sciences & Materials Research Grant. Graduate students and senior undergraduates enrolled at a North American college or university who are studying biotechnology, biochemistry, material science/engineering, or related fields with an interest in micro-particle analysis are encouraged to apply for the use of a FlowCAM dynamic imaging particle analyzer to support their research.
   
  The winner of the award will receive use of a FlowCAM for a period of up to four months, instrument training and on-going technical support, and a paid trip to an appropriate North American conference within 12 months of project completion to share the results of their work.  Judging criteria will include scientific merit, appropriate use of the FlowCAM, and the ability to obtain measurable results during a research period of four months. Proposals are due May 16, 2014. 

Fluid Imaging Technologies calls for submissions for its Life Sciences & Materials Research Grant.

Fluid Imaging Technologies Seeks Submissions for Research Grant

 has entered a license agreement with a subsidiary of Merck & Co. for small molecule compounds targeting an undisclosed intracellular target for use as leads in Merck’s drug discovery and development. Under the terms of the agreement, Merck will gain exclusive rights for the further development and commercialization of the compounds. 

This is the second agreement between Nuevolution and Merck. Nuevolution will receive an undisclosed upfront payment and milestone payments for certain preclinical, clinical, and agreed upon commercial milestones. In addition, Nuevolution is eligible to receive royalties on the commercial sales of approved products. Further financial details were not disclosed.

Nuevolution enters a license agreement with a subsidiary of Merck for small molecule compounds.