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Elpamotide
Elpamotide str drawn bt worlddrugtracker Elpamotide L-Arginyl-L-phenylalanyl-L-valyl-L-prolyl-L-alpha-aspartylglycyl-L-asparaginyl-L-arginyl-L-isoleucine human soluble (Vascular Endothelial Growth...
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Oliceridine
Oliceridine N-[(3-methoxythiophen-2-yl)methyl]-2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethan-1-amine [(3-Methoxythiophen-2-yl)methyl]({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-...
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Galunisertib
Galunisertib Phase III A TGF-beta receptor type-1 inhibitor potentially for the treatment of myelodysplastic syndrome (MDS) and solid tumours. LY-2157299 CAS No.700874-72-2...
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Quality Documentation of API mix in the Marketing Authorisation Procedure
DRUG REGULATORY AFFAIRS INTERNATIONAL For different reasons, the manufacture of APIs may sometimes require adding excipients. In the context of an authorisation procedure, this practice reveals to be...
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EMA publishes finalised Process Validation Guideline for Biotech Products
DRUG REGULATORY AFFAIRS INTERNATIONAL Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been...
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Sun Pharma and Merck & Co. Inc. Enter into Licensing Agreement for...
Tildrakizumab (MK-3222) Company Merck & Co. Inc. Description Anti-IL-23 antibody Molecular Target Interleukin-23 (IL-23) Mechanism of Action Antibody Therapeutic Modality Biologic: Antibody Latest...
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Processes for Constructing Homogeneous Antibody Drug Conjugates
Antibody drug conjugates (ADCs) are synthesized by conjugating a cytotoxic drug or “payload” to a monoclonal antibody. The payloads are conjugated using amino or sulfhydryl specific linkers that react...
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A New Antibiotic...
(E)-3-(3-Carboxyphenyl)-2-(4-ethynylstyryl)quinazolin-4(3H)-one (E)-3-(2-(4-Cyanostyryl)-4-Oxoquinazolin-3(4h)-Yl)benzoic Acid; 1624273-22-8 CAS NA SALT 1624273-21-7 CAS INNOVATORS University Of...
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Nolatrexed Dihydrochloride
Nolatrexed NDA Filed in china A thymidylate synthase inhibitor potentially for the treatment of hepatocellular carcinoma and nasopharyngeal cancer. AG-337 CAS No. 147149-76-6 (free) free form data...
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CADROFLOXACIN
Cadrofloxacin , CS 940 3-Quinolinecarboxylic acid, 1-cyclopropyl-8-(difluoromethoxy)-6-fluoro-1,4-dihydro-7-[(3S)-3-methyl-1-piperazinyl]-4-oxo-, hydrochloride (1:1) UNII-1YOQ7J9ACY; 153808-85-6;...
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Arbaclofen
Arbaclofen placarbil (3R)-3-(4-chlorophenyl)-4-[[(1S)-2-methyl-1-(2-methylpropanoyloxy)propoxy]carbonylamino]butanoic acid NDA filed A GABA (B) receptor agonist potentially for the treatment of muscle...
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FDA issues rule for data collection of antimicrobial sales and distribution...
FDA issues rule for data collection of antimicrobial sales and distribution by animal species 05/10/2016 09:28 AM EDT Additional data help further target efforts to ensure judicious use of medically...
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Buthionine Sulphoximine
Buthionine Sulphoximine NDA Filed in china A gamma-glutamylcysteine synthetase inhibitor potentially for the treatment of solid tumors. NSC-326231; BSO CAS No. 5072-26-4 BUTHIONINE SULFOXIMINE;...
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EMA’s new Draft Guideline on the Sterilisation of Medicinal Products, APIs,...
DRUG REGULATORY AFFAIRS INTERNATIONAL For medicinal products administrated in sterile form, the process to reduce the microbial level is a critical manufacturing step with regard to quality. The EMA...
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USP publishes draft of a new general chapter for plastic components used in...
DRUG REGULATORY AFFAIRS INTERNATIONAL In the Pharmacopoeial Forum (PF) 42(3) (May-June 2016) the USP General Chapters – Packaging and Distribution Expert Committee proposes a new general chapter...
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APIs from Legitimate and Reliable Sources
DRUG REGULATORY AFFAIRS INTERNATIONAL APIs from Legitimate and Reliable Sources 1. Introduction Counterfeit and sub-standard APIs are increasingly present. Not only are they a fact of non-compliance...
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BMS-520, a Potent and Selective Isoxazole-Containing S1P1 Receptor Agonist
BMS-520 CAS: 1236188-38-7 MF: C23H17F3N4O4 MW: 470.1202 Synonym: BMS-520; BMS 520; BMS520. INNOVATOR Bristol-Myers Squibb Company INVENTORS Scott Hunter Watterson, Alaric J. Dyckman,William J. Pitts,...
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7th Annual Clinical Trials Summit 2016, 24th May 2016, The Lalit Hotel,...
“7th Annual Clinical Trials Summit 2016” “A critical guide for successfully conducting clinical...
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CDRI 830
CDRI 830 CDRI S006-830 N-[2-[4-[(4-methoxyphenyl)-thiophen-2-ylmethyl]phenoxy]ethyl]-N-propan-2-ylpropan-2-amine Molecular Formula: C26H33NO2S Molecular Weight: 423.61072 g/mol CDRI-830 of thiophene...
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Letermovir, AIC 246
Letermovir, MK 8828, AIC 246 2-[(4S)-8-fluoro-2-[4-(3-methoxyphenyl)piperazin-1-yl]-3-[2-methoxy-5-(trifluoromethyl)phenyl]-4H-quinazolin-4-yl]acetic acid CAS 917389-32-3 Letermovir; UNII-1H09Y5WO1F;...
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