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Ligand Partner Spectrum Pharmaceuticals Announces Submission of New Drug Application for Captisol-Enabled Melphalan

Posted: Published on December 26th, 2014

According to Spectrum Pharmaceuticals, the Captisol-enabled Melphalan NDA was filed under a 505(b)(2) application and Spectrum expects FDA review to take approximately 10 months. Spectrum plans to launch this drug with its existing hematology/oncology sales force next year pending approval. We congratulate the team at Spectrum Pharmaceuticals on their development progress, said John Higgins, Ligands President and Chief Executive Officer. With a specialty sales force already in place, we look forward to Spectrums potential launch and commercial success with this valuable asset. Ligand licensedglobal development and commercialization rights toCE-Melphalan to Spectrum in 2013. Spectrum assumed the responsibility for a pivotal clinical trial and was responsible for filing the NDA. Under the license agreement, Ligand received a license fee and is eligible to receive revenue from Captisol material sales, milestone payments, as well as royalties on net sales following potential commercialization. According to previous announcements by Spectrum, the Phase 2 pivotal trial evaluating CE-Melphalan was a multicenter trial evaluating safety and efficacy. The primary objective of the study was to determine the overall safety and toxicity profile in multiple myeloma patients receiving 200 mg/m2 of CE-Melphalan as myeloablative therapy prior to autologous stem cell transplantation (ASCT). The secondary objectives evaluated the … Continue reading

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Spectrum Pharma Submits NDA For CE-Melphalan

Posted: Published on December 26th, 2014

Spectrum Pharmaceuticals, Inc. (SPPI: Quote) said Friday that it has submitted a New Drug Application or NDA to the U.S. Food and Drug Administration for approval of Captisol-Enabled Melphalan HCl for injection to be used as a high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma. Henderson, Nevada-based Spectrum Pharma is also seeking approval for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. The biotechnology company noted that the NDA submission represented an important step forward in bringing new treatment options to cancer patients. Spectrum Pharma expects the FDA review to take about 10 months, and plans to launch the drug with its existing hematology and oncology sales force next year pending approval. The company noted that its formulation is free of propylene glycol and does not use a custom solvent for its reconstitution. Spectrum Pharma gained global development and commercialization rights to CE-Melphalan from Ligand Pharmaceuticals Inc. (LGND: Quote) in March 2013. The company assumed the responsibility for the pivotal clinical trial and was responsible for filing the NDA for CE-Melphalan. Under the license agreement, Ligand received a license fee and is eligible to receive milestone payments, as … Continue reading

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IVF Treatment In India IVF Treatment in Delhi – Video

Posted: Published on December 26th, 2014

IVF Treatment In India IVF Treatment in Delhi We Care India IVF Clinic is India's leading fertility center in Delhi, India. We provide male female infertility treatment, confidential counselling for te... By: Indiahospital Tour … Continue reading

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Human Genetics I – Video

Posted: Published on December 26th, 2014

Human Genetics I By: McIntoshBiology … Continue reading

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Chilla K. (Ft. B1 The Menace) – Genetics (King Kold II) – Video

Posted: Published on December 26th, 2014

Chilla K. (Ft. B1 The Menace) - Genetics (King Kold II) DOWNLOAD LINK HERE!!!!: https://soundcloud.com/chilla-k/chilla-k-ft-b1-the-menace-genetics-king-kold-ii This is the second official single off of Chilla K.'s upcoming mixtape, dFrost! Share,... By: Chilla K … Continue reading

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Bangladesh in Genetic Engineering – Video

Posted: Published on December 26th, 2014

Bangladesh in Genetic Engineering ALJAGIRA-TV_News for Bangladesh Bangladesh in Genetic Engineering. By: Bjri Barj … Continue reading

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Surgical Technique for AADC Gene Therapy. Prof John Heiss – Video

Posted: Published on December 26th, 2014

Surgical Technique for AADC Gene Therapy. Prof John Heiss Prof. John Heiss, National Institute of Health NINDS - USA Surgical Technique for AADC Gene Therapy Summary: The history of delivering gene therapy to the central nervous system will be... By: aadcresearch … Continue reading

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Embryology Dr Hossam [Placenta] 20 December 2014 – Video

Posted: Published on December 26th, 2014

Embryology Dr Hossam [Placenta] 20 December 2014 By: Forsan El Kasr 2014.2020 … Continue reading

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Trumbull Fertility and IVF Center Announces Advances in Fertility Treatment and IVF Laboratory Techniques

Posted: Published on December 26th, 2014

Trumbull, CT (PRWEB) December 26, 2014 Park Avenue Fertility and Reproductive Medicine (PAFRM), located in Trumbull, CT with satellite offices in both Norwalk and Fairfield, CT, is proud to announce technological advances involving their IVF medical treatment protocols as well in their IVF laboratory. Says Founder and Medical Director, Dr. Andrew Levi, Unlike other large volume-driven IVF centers, we are able to recommend IVF protocols to patients that are more personalized, are focused on both embryo quality and embryo implantation, and that ultimately will lead to higher pregnancy and live-birth rates. We have come to recognize that our attention to detail and personalized care makes a difference in terms of the end result a successful pregnancy. We believe that our team of clinicians and embryology staff delivers the highest level of fertility care in the state of Connecticut. In addition to the utilization of novel stimulation protocols, PAFRM continues to focus on elective single embryo transfer (eSET). Using eSET, the center has excelled in achieving the highest pregnancy rates while minimizing multiple pregnancies. Dr. Levi adds, One of the ways that we are able to attain such high pregnancy rates is by using a technique called Comprehensive Chromosome Screening, known … Continue reading

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DNA Bomb- Sweet Spawns Bro – Video

Posted: Published on December 26th, 2014

DNA Bomb- Sweet Spawns Bro Livestream link: http://www.twitch.tv/xmunajj Twitter: https://twitter.com/xmunajj. By: Munajj Ahmad … Continue reading

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