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...
View ArticleFDA releases draft guidance on the use of comparability protocols for post...
DRUG REGULATORY AFFAIRS INTERNATIONAL The US FDA released a draft guidance for industry “Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information”.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...
View ArticleFive 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...
View ArticleNew FDA Draft Guidance ‘Data Integrity and Compliance with cGMP’ published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...
View ArticleVX-? , 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,...
View ArticleCebranopadol 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...
View ArticleBoldenone 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)...
View ArticleElpamotide
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...
View ArticleOliceridine
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-...
View ArticleGalunisertib
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...
View ArticleQuality 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...
View ArticleEMA 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...
View ArticleSun 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...
View ArticleProcesses 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...
View ArticleA 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...
View ArticleNolatrexed 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...
View ArticleCADROFLOXACIN
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;...
View ArticleArbaclofen
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...
View ArticleFDA 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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