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FDA May 2014 Products Receiving Orphan Designation
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The chart below identifies FDA May 2014 Products Receiving Orphan Designation as of 05/31/14 in ascending “Orphan Drug Designation Date” order.
FDA May 2014 Products Receiving Orphan Designation
| # | Generic Name/ODD Date | Sponsor Company | Indication |
| 1 | Filanesib/ 05.06 | Array BioPharma | Multiple Myeloma |
| 2 | Autologous dendritic cells pulsed with allogeneic tumor cell lysate/ 05.06 | Amphera BV (Netherlands) | Malignant Mesothelioma |
| 3 | Ex vivo cultured human mesenchymal stromal cells / 05.08 | iCell Science AB (Sweden) | Prevention of graft rejection following solid organ transplantation |
| 4 | Adalimumab/ 05.13 | AbbVie | Uveitis |
| 5 | Diazoxide choline / 05.13 | Essentialis | Prader-Willi Syndrome |
| 6 | Vasoactive intestinal peptide (VIP)-elastin-like peptide (ELP) fusion protein / 05.13 | PhaseBio Pharmaceuticals | Pulmonary arterial hypertension |
| 7 | (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N-(pyrazin-2-yl)acrylohydrazide / 05.14 | Karyopharm Therapeutics | Diffuse large B-cell lymphoma |
| 8 | 177Lu-tetraxetan-tetulomab / 05.14 | Nordic Nanovector AS (Norway) | Follicular Lymphoma |
| 9 | Selinexor; (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N-(pyrazin-2-yl)acrylohydrazide / 05.14 | Karyopharm Therapeutics | Acute myeloid leukemia |
| 10 | Menadione Sodium Bisulfite/ 05.14 |
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Cocrystals

Active pharmaceutical ingredients (APIs) are frequently delivered to the patient in the solid state as part of such dosage forms as tablets, capsules, etc.In this context the ability to deliver the drug to the patient in a safe, efficacious and cost-effective way depends largely on the physicochemical properties of the APIs in the solid state, and ……..read more
API SCALEUP (R AND D)
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| The ultimate goal of drug synthesis is to scale up from producing milligram quantities in a laboratory to producing kilogram to ton quantities in a plant, all while maintaining
all at |
Polymer Nanoflower Encapsulates Two Cancer Drugs to Hit Tumors with More Punch
Many existing anti-cancer drugs can be disappointingly ineffective in clinical practice, but often it is the delivery method and not the medication itself that limits effectiveness. Being able to deliver multiple drugs together, each with a different mechanism of action, to their target can be considerably more powerful than separate administrations. Researchers at North Carolina State University and the University of North Carolina at Chapel Hill have developed a “nanoflower” made out of a hydrophilic polymer that carries camptothecin and doxorubicin directly into cancer cells.

The hydrophobic drugs are encapsulated within the polyethylene glycol structure similarly to how proteins fold in on themselves. At about 50 nanometers in diameter, the nanoflowers can be injected into the bloodstream to seek out cancer cells. In an animal study, the structures stayed together until they penetrated lung cancer cells by taking advantage of “lipid raft and clathrin-mediated endocytotic pathway without premature leakage,” according…
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आयुर्वेद न्यूट्रास्यूटीकल्स ; अधिक गर्मी के कारण होने वाली तकलीफो से बचने के लिये ………
आयुर्वेद की विशेषता यही है कि सभी मौसम के लिये सभी के लिये आयुर्वेद के मनीषियों ने मौसम से प्राप्त सभी वस्तुओ के सटीक उपयोग के लिये combinations दे दिये है /
गर्मी के मौसम मे गर्म हवाओ के चलने और लू लपट high degree temperature के चलते हुये बहुत सी तकलीफे शरीर मे अचानक पैदा होने की स्तिथि बन जाती है , इन सभी अवस्थाओ से बचने के लिये नीचे लिखे nueutraceutical को अपनाइये और फायदा उठाइये ;
साम्ग्री सब आप्के किचन मे मिल जायेगी /
१- एक छोटा प्याज , बड़ा हो तो आधा कर ले
२- एक कच्चा छोटा आम / अमिया
३-१५ -२० पुदीना की पत्ती / अधिक भी छोड़ सकते है
४- एक टुकड़ा अदरख
५- एक चम्मच जल जीरा मसाला पाउडर
५- आधा चम्मच काली मिर्च
६- स्वादानुसार काला नमक
७- एक या दो चम्मच शक्कर / चीनी / गुड़
८- आधा या…
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Late-stage fluorination, what do you think ?
Hi Everyone, I have really been appreciating the visits to my blog. I had resurrected this dormant site blog a while ago and hoped I could get a fair number of visits. I have been overwhelmed with the response. Some of the posts were clear winners, like the Revlimid case, for sure. I, recently, came across this review in Organic Process Research & Development and realized there probably would be two sides to this argument.
Late-stage fluorination. The current review in OPRD can be found at Michael G. Campbell and Tobias Ritter*, “Late-Stage Fluorination: From Fundamentals to Application”, Org. Process Res. Dev. 2014, 18, 474−480
doi: 10.1021/op400349g
I remember, many years ago, discussing this with a colleague about adding a fluorine group to a molecule. We both agreed that it would be far better to add a fluorine early on the synthesis, so if there were side-products, you would…
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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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