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Channel: DR ANTHONY MELVIN CRASTO Ph.D – New Drug Approvals
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Monoclonal Antibody Therapy: What is in the name or clear description?

Originally posted on Leaders in Pharmaceutical Business Intelligence: Monoclonal Antibody Therapy: What is in the name or clear description? Curator: Demet Sag, PhD, CRA, GCP  What is in the name?...

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Multistep Flow Synthesis of 5-Amino-2-aryl-2H-[1,2,3]-triazole-4-...

Using the Uniqsis FlowSyn flow chemistry system researchers from the UCB Biopharma. Belgium have developed a flow synthesis of 2-substituted 1,2,3-triazoles that demonstrates improvements over the...

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Etelcalcetide, AMG 416, KAI-4169, velcalcetide

H-L-Cys-OH S— S Ac-D-Cys-D-Ala-D-Arg-D-Arg-D-Arg-D-Ala-D-Arg-NH2 AMG 416 IS  (Ac-D-Cys(L-Cys-OH)-D-Ala-D-Arg-D-Arg-D-Arg-D-Ala-D-Arg-NH2) Etelcalcetide (AMG 416, KAI-4169, velcalcetide) The main chain...

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FDA approves Praxbind, Idarucizumab the first reversal agent for the...

FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa 10/16/2015 01:07 PM EDT The FDA has granted accelerated approval to Praxbind (idarucizumab) for use in patients who are...

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VARDENAFIL

VARDENAFIL 224785-90-4  CAS NO Vardenafil hydrochloride (CAS NO.224785-91-5) Formula C23H32N6O4S  Mol. mass 488.604 g/mol...

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Ribociclib

  Ribociclib Ribociclib (LEE011) CAS: 1211441-98-3 Chemical Formula: C23H30N8O Exact Mass: 434.25426 7-Cyclopentyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxylic acid...

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Abemaciclib (Bemaciclib)

Abemaciclib (Bemaciclib) N-[5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl]-5-fluoro-4-(7-fluoro-2-methyl-3-propan-2-ylbenzimidazol-5-yl)pyrimidin-2-amine 2-Pyrimidinamine,...

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Pramipexole

Pramipexole, (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole, represented by the following formula I (the compound of formula I), is a dopamine D2/D3 agonist used for treatment of...

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TAK 272, For Hypertension, Takeda’s Next Sartan

TAK 272 C27 H41 N5 O4 . Cl H, 536.106 Takeda Pharmaceutical Company Limited, INNOVATOR...

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FDA approves first Factor X concentrate to treat patients with rare...

FDA approves first Factor X concentrate to treat patients with rare hereditary bleeding disorder 10/20/2015 The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human),...

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Dr. Ashok Kumar, President – Research and Development (Chemical) at IPCA...

Dr. Ashok Kumar PRESIDENT – R&D (Chemical) at IPCA LABORATORIES LTD LINKS https://in.linkedin.com/pub/ashok-kumar/16/6a7/903  Intro The 25-year process patent regime allowed a large number of...

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Regulation of Herbal (Traditional) Medicinal Products in the European Union

      Regulation of Herbal (Traditional) Medicinal Products in the European Union Introduction The European Union (EU) regulatory framework for medicinal products is complex and is based on the need of...

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FDA grants breakthrough status for Pfizer’s leukaemia drug inotuzumab ozogamicin

  Inotuzumab ozogamicin RN: 635715-01-4 UNII: P93RUU11P7 Pfizer Inc., Oncology Institute Of Southern Switzerland  INNOVATOR http://chem.sis.nlm.nih.gov/chemidplus/rn/635715-01-4 MF 1680.6764...

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Mavatrep, JNJ 39439335,

Mavatrep; UNII-F197218T99; Mavatrep (USAN); JNJ-39439335; 956274-94-5; 2-(2-(2-(2-(4-trifluoromethylphenyl)vinyl)-1H-benzimidazol-5-yl)phenyl)propan-2-ol...

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MARIZEV® (Omarigliptin), Merck’s Once-Weekly DPP-4 Inhibitor for Type 2...

MARIZEV® (Omarigliptin), Merck’s Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and...

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IPI 504, Retaspamycin, Retaspimycin

IPI 504, Retaspamycin, Retaspimycin CAS 857402-63-2 Cas 857402-23-4 ( Retaspimycin); 857402-63-2 ( Retaspimycin  HCl). MF C31H45N3O8 BASE MW: 587.32067 BASE Infinity Pharmaceuticals Inc,  INNOVATOR...

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New “mTOR” inhibitor from Exelixis, Inc., XL 388

XL 388  A Novel Class of Highly Potent, Selective, ATP-Competitive, and Orally Bioavailable Inhibitors of the Mammalian Target of Rapamycin (mTOR) Benzoxazepine-Containing Kinase Inhibitor...

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Voxtalisib, SAR-245409, XL-765

Voxtalisib SAR-245409, XL-765 2-amino-8-ethyl-4-methyl-6-(1H-pyrazol-3-yl)pyrido[2,3-d]pyrimidin-7(8H)-one 2-Amino-8-ethyl-4-methyl-6-(1H-pyrazol-5-yl)pyrido[2,3-d]pyrimidin-7(8H)-one hydrochloride...

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What are “complex manufacturing processes”? A recent reply from the EMA

Originally posted on DRUG REGULATORY AFFAIRS INTERNATIONAL: Sometimes a clear definition of terms is crucial in the communication between authorities and pharmaceutical companies. Find out what the...

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Study Demonstrates Efficacy of New Tumor Treatment

Study Demonstrates Efficacy of New Tumor Treatment The results of a study demonstrate the efficacy of this drug in treating nonfunctional neuroendocrine tumors of lung or gastrointestinal origin. FULL...

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