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Channel: DR ANTHONY MELVIN CRASTO Ph.D – New Drug Approvals
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Kiran Mazumdar Shaw Conferred with ‘The Global Leadership in Engineering...

.   http://societyofwomenengineers.swe.org/awards/individual-awards/4153-global-leadership The Global Leadership Award honors a person with at least fifteen (15) years professional experience who has...

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Lobeglitazone Sulfate

  Lobeglitazone Sulfate, CKD-501 (Duvie®) Approved Chong Kun Dang (Originator) A dual PPARα and PPARγ agonist used to treat type 2 diabetes. Trade Name:Duvie®MOA:Dual PPARα and PPARγ...

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Blinatumomab

Blinatumomab, AMG-103,  MEDI-538,  MT-103, (Blincyto®) Approved A bispecific CD19-directed CD3 T-cell engager used to treat philadelphia chromosome-negative relapsed or refractory B-cell precursor...

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Istradefylline

Istradefylline, KW-6002 (Nouriast®) Approved A selective adenosine A2A receptor antagonist used to treat Parkinson’s disease. KW-6002 CAS No. 155270-99-8 Istradefylline; 155270-99-8; KW-6002; KW 6002;...

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Reslizumab

Reslizumab (Cinqair®) Approved Active, FDA 2016-03-23 An interleukin-5 (IL-5) antagonist used to treat severe asthma. CAS  241473-69-8 Research Code CDP-835; CEP-38072; CTx-55700; SCH-5570; SCH-55700;...

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Daratumumab

Daratumumab (Darzalex®)Approved An anti-CD38 monoclonal antibody used to treat multiple myeloma. Research Code HuMax-CD-38; HuMaxCD-38 CAS No. Daratumumab (HuMax®-CD38) Daratumumab (Darzalex) is an...

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Idarucizumab

Idarucizumab (Praxbind®) Approved An antidote for rapid reversal of dabigatran-induced anticoagulation indicated for emergency surgery (urgent procedures) and life-threatening or uncontrolled bleeding...

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Asfotase alfa

  > Asfotase Alfa Sequence LVPEKEKDPKYWRDQAQETLKYALELQKLNTNVAKNVIMFLGDGMGVSTVTAARILKGQL HHNPGEETRLEMDKFPFVALSKTYNTNAQVPDSAGTATAYLCGVKANEGTVGVSAATERS...

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Albutrepenonacog alfa

1YNSGKLEEFV QGNLERECME EKCSFEEARE VFENTERTTE FWKQYVDGDQ 51CESNPCLNGG SCKDDINSYE CWCPFGFEGK NCELDVTCNI KNGRCEQFCK 101NSADNKVVCS CTEGYRLAEN QKSCEPAVPF PCGRVSVSQT SKLTRAETVF 151PDVDYVNSTE AETILDNITQ...

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Lurasidone hydrochloride, Jubilant Generics Ltd, WO 2016059649, New patent

Lurasidone Lurasidone hydrochloride, Jubilant Life Sciences Ltd, WO 2016059649, New patent An improved process for the preparation of lurasidone hydrochloride Jubilant Life Sciences Ltd WO 2016059649...

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New Patent, Tedizolid phosphate, Suzhou MiracPharma Technology Co Ltd, Zheren...

Tedizolid phosphate Suzhou MiracPharma Technology Co Ltd; Zheren Pharmaceutical Nanjing Co Ltd WO-2016058467   click for patent SUZHOU MIRACPHARMA TECHNOLOGY CO., LTD [CN/CN]; Room 1305, Building 1...

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Cymipristone

Cymipristone (8S,11R,13S,14S,17S)-11-{4-[Cyclohexyl(méthyl)amino]phényl}-17-hydroxy-13-méthyl-17-(1-propyn-1-yl)-1,2,6,7,8,11,12,13,14,15,16,17-dodécahydro-3H-cyclopenta[a]phénanthrén-3-one...

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энкломифен Enclomiphene citrate إينكلوميفان

Enclomiphene citrate NDA FILED Hypogonadism, Repros Therapeutics An estrogen receptor (ER) antagonist potentially for treatment of hypogonadotropic hypogonadism. ICI-46476; RMI-16289 CAS...

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FDA releases draft guidance on the use of comparability protocols for post...

DRUG REGULATORY AFFAIRS INTERNATIONAL The US FDA released a draft guidance for industry “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”. The...

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Five new General Chapters in the European Pharmacopoeia on Genotoxic...

DRUG REGULATORY AFFAIRS INTERNATIONAL During the manufacture of APIs as sulfonate salts, esters of sulfonic acid may develop in undesired chemical side reactions. Recently, five new General Monographs...

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New FDA Draft Guidance ‘Data Integrity and Compliance with cGMP’ published

DRUG REGULATORY AFFAIRS INTERNATIONAL In the last years, the topic “data integrity” has become a priority for the FDA. Recently, the Agency has published the draft of a Guidance for Industry on the...

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ASP 3026

ASP3026 ASP3026; CAS 1097917-15-1; ASP-3026; ASP 3026; UNII-HP4L6MXF10;...

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VX-? , an Azaindolyl-Pyrimidine Inhibitor of Influenza Virus Replication from...

VX-? An Azaindolyl-Pyrimidine Inhibitor of Influenza Virus Replication from Vertex SYNTHESIS COMING…….. CAS 1259498-06-0 MF C23 H27 F2 N7 O, MW, 455.50 1-Piperidinecarboxamide,...

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Cebranopadol hemicitrate, セブラノパドール

Cebranopadol hemicitrate, GRT-6005 Phase III  Grünenthal GmbH  innovator SYNTHESIS COMING WATCH OUT………. A mu-opioid agonist for treatment of neuropathic pain and pain due to osteoarthritis. CAS...

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Boldenone Undecylenate

Boldenone Undecylenate cas 13103-34-9, C30 H44 O3,   452.67 Androsta-1,4-dien-3-one, 17-[(1-oxo-10-undecenyl)oxy]-, (17β)- Androsta-1,4-dien-3-one, 17β-hydroxy-, 10-undecenoate (7CI,8CI)...

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