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Curis and Aurigene’s CA 4948, AU 4948
Example 13 WO2015104688 6-(6-aminopyridin-3-yl)-N-(2-morpholin-4-yl-1,3-benzothiazol-6-yl)pyridine-2-carboxamide Molecular Formula: C22H20N6O2S Molecular Weight: 432.4982 g/mol 1428335-77-6...
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FDA approves new drug Venclexta (venetoclax) for chronic lymphocytic leukemia...
Venclexta (venetoclax) SYNTHESIS...
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Zamicastat
CAS 1080028-80-3 BASE 1383828-47-4 OF HCL SALT C21 H21 F2 N3 O S BASE 2H-Imidazole-2-thione, 1-[(3R)-6,8-difluoro-3,4-dihydro-2H–...
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ETAMICASTAT
Etamicastat HCl salt CAS: 677773-32-9 (HCl salt) CAS 760173-05-5 (free base). Chemical Formula: C14H16ClF2N3OS Molecular Weight: 347.8088 Synonym: BIA 5-453; BIA5-453; BIA-5-453; Etamicastat...
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PF-05387552
PF-05387552 IRAK4 CAS 1604034-71-0 C25 H27 N5 O2 11H-Indolo[3,2-c]quinoline-9-carbonitrile, 2-methoxy-3-[3-(4-methyl-1-piperazinyl)propoxy]-...
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Asvasiran sodium (ALN-RSV01)
RNA, (C-U-U-G-A-C-U-U-U-G-C-U-A-A-G-A-G-C-C-DT-DT), COMPLEX WITH RNA (G-G-C-U-C-U-U-A-G-C-A-A-A-G-U-C-A-A-G-DT-DT) Duplex of...
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GSK-525762A
GSK 525762A; 1260907-17-2; I-BET-762; GSK525762A; UNII-5QIO6SRZ2R; 5QIO6SRZ2R; CAS1260907-17-2...
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TAK-058 (ENV-8058)
TAK-058 , ENV-8058 5-HT 3 receptor antagonist Envoy Therapeutics, Inc. 1-(1-methyl-1H-pyrazol-4-yl)-N-((1R,5S,7S)-9-methyl-3-oxa-9-azabicyclo[3.3.1]nonan-7-yl)-1H-indole-3-carboxamide...
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Henagliflozin
Henagliflozin, SHR-3824 , CAS 1623804-44-3 C22-H24-Cl-F-O7 454.8756 PHASE 2 for the treatment of type 2 diabetes HengRui (Originator) Jiangsu Hengrui Medicine Co Ltd UNII-21P2M98388; 21P2M98388;...
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ATR 101
N-(2,6-bis(1-methylethyl)phenyl)-N’-((1-(4-(dimethylamino)phenyl)cyclopentyl) methyl)urea hydrochloride N-(2,6-BIS(l-METHYLETHYL)PHENYL)-N’-((l-(4- (DIMETHYLAMINO)PHENYL)CYCLOPENTYL)METHYL)UREA...
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Enasidenib (AG-221)
Enasidenib (AG-221) 1446502-11-9 Chemical Formula: C19H17F6N7O Exact Mass: 473.13988 AG-221; AG 221; AG221; CC-90007; CC 90007; CC90007; Enasidenib IUPAC/Chemical Name:...
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Regulatory Approval Pathways: EU vs US
DRUG REGULATORY AFFAIRS INTERNATIONAL Regulatory Approval Pathways: EU vs US Drug Authorization Procedures in the EU Sponsors have several options when seeking market approval for a new drug in...
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1R,2S-Methoxamine
1R,2S-methoxamine, also known as L-erythro-methoxamine CAS 13699-29-1 Benzenemethanol, α-[(1S)-1-aminoethyl]-2,5-dimethoxy-, (αR)- Benzenemethanol, α-(1-aminoethyl)-2,5-dimethoxy-, [R-(R*,S*)]-...
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Plecanatide 普卡那肽 ليكاناتيد плеканатид
PLECANATIDE; UNII-7IK8Z952OK; (3-Glutamic acid(D>E))human uroguanylin (UGN); 467426-54-6; Molecular Formula: C65H104N18O26S4 Molecular Weight: 1681.88626 g/mol IUPAC Condensed...
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GMP/GDP: When will I be inspected by the Authorities?
DRUG REGULATORY AFFAIRS INTERNATIONAL Various competent authorities are performing inspections. But who is subject to such an inspection?...
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GMP Oversight of Medicines Manufacturers in the European Union
DRUG REGULATORY AFFAIRS INTERNATIONAL A System of Equivalent Member States, a Coordinating Agency and a Centralized Institution The regulatory system for supervision of pharmaceutical manufacturers...
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Polmacoxib, CG-100649
Polmacoxib, CG-100649 (Acelex®)Approved A COX-2 inhibitor used to treat osteoarthritis. OriginatorCrystalGenomics ClassAntirheumatics; Benzene derivatives; Fluorobenzenes; Furans; Nonsteroidal...
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NEW PATENT, WOCKHARDT LIMITED, WO 2016055918, ISAVUCONAZOLE
WO2016055918) NOVEL STABLE POLYMORPHS OF ISAVUCONAZOLE OR ITS SALT THEREOF WOCKHARDT LIMITED [IN/IN]; D-4, MIDC Area, Chikalthana, Aurangabad 431006 (IN) KHUNT, Rupesh Chhaganbhai; (IN). RAFEEQ,...
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Vonoprazan Fumarate
1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine fumarate Vonoprazan Fumarate (Takecab®) Approved Vonoprazan Fumarate CAS#: 1260141-27-2 (fumarate); 881681-00-1...
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Pemafibrate
Pemafibrate NDA Filing Japan, Phase 2 in EU, US A PPAR-α agonist potentially for the treatment of dyslipidemia. K-877, K-13675, (R)- CAS No. 848259-27-8, Molecular Formula,C28-H30-N2-O6,Molecular...
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