FDA approves Amjevita, a biosimilar to Humira

It’s only fair to share… FDA approves Amjevita, a biosimilar to Humira The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar toHumira (adalimumab) for multiple inflammatory diseases. Read more. FDA approves Amjevita, a biosimilar to Humira For Immediate Release September 23, 2016 Release The U.S. Food and Drug Administration today approved …

9th Biosimilars Congregation 2016., Lalit hotel, Mumbai, India, 22nd Sept 2016

It’s only fair to share… Thanks to Fen Castro of VirtueInsight, Director for inviting me to 9th Biosimilars Congregation 2016., Lalit hotel, Mumbai, India, 22nd Sept 2016……..http://www.virtueinsight.com/pharma/9th-Biosimilars-Congregation-2016/ with Fen Castro of VirtueInsight, Director , and his team , , —thanks for inviting me to 9th Biosimilars Congregation 2016., Lalit hotel, Mumbai, India, 22nd Sept 2016 …

Uridine triacetate

It’s only fair to share…     Uridine triacetate Uridine, 5-hydroxy-, 2′,3′,5′-triacetate 2′,3′,5′-Tri-O-acétyluridine 223-881-5 [EINECS] CAS 4105-38-8 Priority review drug  Orphan drug FAST TRACK MF C15H18N2O9, MW 370.314 [(2R,3R,4R,5R)-3,4-bis(acetyloxy)-5-(2,4-dioxo-1,2,3,4-tetrahydropyrimidin-1-yl)oxolan-2-yl]methyl acetate Vistogard [Trade name] Xuriden [Trade name] (2R,3R,4R,5R)-2-(acetoxymethyl)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)tetrahydrofuran-3,4-diyl diacetate Wellstat (Originator) PN-401; RG-2133; TAU MOA:Pyrimidine analog Indication:Hereditary orotic aciduria; Chemotherapy induced poisoning To treat patients with hereditary orotic aciduria Drug …

DROXIDOPA

It’s only fair to share… DROXIDOPA ORPHAN DRUG, CAS 23651-95-8, 3916-18-5 ROTATION   –FORM (2S,3R)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid 223-480-5 [EINECS], L-Tyrosine, β,3-dihydroxy-, (βR)-, L-Tyrosine, β,3-dihydroxy-, threo- Northera [Trade name] threo-b,3-Dihydroxy-L-tyrosine 1-14-00-00685 [Beilstein], L-threo-3-(3,4-Dihydroxyphenyl)serine, L-Dihydroxyphenylserine, L-DOPS;DOPS, \ Northera, SM5688, L-DOPS|Northera®, |SM-5688, L-threo-dihydroxyphenylserine, L-Threodops L-threo-droxidopa, threo-2-Amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropionic acid THREO-DIHYDROXYPHENYLSERINE threo-Dopaserine UNII:24A0V01WKS UNII:J7A92W69L7 FDA 2/18/2014, FDA approves Northera to treat neurogenic orthostatic hypotension Properties: Crystals from ethanol and ether, mp 232-235° (dec). [a]D20 -39° …

Pimavanserin

It’s only fair to share… Pimavanserin MF C25H34FN3O2 MW 427.555 Pimavanserin, ACP 103, ACP-103; BVF-048 N-(4-fluorophenylmethyl)-N-(1-methylpiperidin-4-yl)-N’-(4-(2-methylpropyloxy)phenylmethyl)carbamide, 706779-91-1 (Pimavanserin ) 706782-28-7 (Pimavanserin Tartrate) for treatment of psychotic symptoms in patients with Parkinson’s disease WATCH OUT AS THIS POST IS UPDATED……….. Trade Name:Nuplazid® MOA:5-HT2A inverse agonist Indication:Hallucinations and delusions associated with Parkinson’s disease psychosis Company:Acadia (Originator) APPROVED US FDA 2016-04-29, ACADIA PHARMS INC, (NDA) …

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

It’s only fair to share… CAS 1173755-55-9 eteplirsen, eteplirsén [Spanish], étéplirsen [French] , eteplirsenum [Latin], этеплирсен [Russian], إيتيبليرسان [Arabic] Structure credit http://lgmpharma.com/eteplirsen-still-proves-efficacious-duchenne-drug/ FDA grants accelerated approval to first drug for Duchenne muscular dystrophy New therapy addresses unmet medical need The U.S. Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy …

Ranolazine, 雷诺嗪

It’s only fair to share… Ranolazine 雷诺嗪 MF C24H33N3O4 MW 427.536 Approvals FDA 2006, EMA 2008 for chronic angina Sponsor/Developer: Gilead Mechanism of action: Late sodium current inhibitor Indication (Phase): Type 2 diabetes (Phase III) A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone (currently recruiting participants …

Imidafenacin, イミダフェナシン

It’s only fair to share… Imidafenacin イミダフェナシン Cas 170105-16-5 C20H21N3O, 319.408 APPROVED JAPAN 2015-07-29 4-(2-methyl-1H-imidazol-1-yl)-2,2-diphenylbutanamide 4-(2-methylimidazol-1-yl)-2,2-di(phenyl)butyramide D06273 KRP-197 KRP-197;ONO-8025 ONO-8025 UNII:XJR8Y07LJO Company:Kyorin (Originator), Ono (Originator)  4-(2-methyl-1-imidazolyl)- 2,2-diphenylbutyramide as a colorless needle: mp 189.0±190.0 C (from ethyl acetate:ethanol); High MS (EI+) m/z calcd for C20H21N3O 319.1685, found 319.1671; 1 H NMR (400 MHz, CDCl3) d 2.23 (3H, s), …

JNJ 54166060

It’s only fair to share… JNJ 54166060 JNJ-54166060; JNJ 54166060; JNJ54166060. (R)-(2-chloro-3-(trifluoromethyl)phenyl)(1-(5-fluoropyridin-2-yl)-4-methyl-1,4,6,7-tetrahydro-5H-imidazo[4,5-c]pyridin-5-yl)methanone [2-chloro-3-(trifluoromethyl)phenyl]-[(4R)-1-(5-fluoropyridin-2-yl)-4-methyl-6,7-dihydro-4H-imidazo[4,5-c]pyridin-5-yl]methanone Methanone, [2-chloro-3-(trifluoromethyl)phenyl][(4R)-1-(5-fluoro-2-pyridinyl)-1,4,6,7-tetrahydro-4-methyl-5H-imidazo[4,5-c]pyridin-5-yl]- CAS 1627900-41-7 OF R ISOMER  DESIRED CAS 1627900-42-8 OF S ISOMER Chemical Formula: C20H15ClF4N4O Exact Mass: 438.0871 JNJ-54166060 is a potent P2X7 antagonist. Bioactivity data of JNJ-54166060: rP2X7 IC50=4 nM; rP2X7 IC50=115nM; HLM/RLM = 0.35/0.64, ED50 = 2.3 mg/kg in rats. JNJ-54166060 …

(3S)-3-[(2-amino-5-methoxypyrimidin-4-yl)amino]heptan-1-ol for the treatment of viral infections

It’s only fair to share… (3S)-3-[(2-amino-5-methoxypyrimidin-4-yl)amino]heptan-1-ol cas  1402802-45-2 JNJ ? WO 2012136834, WO 2014053595 for the treatment of viral infections Molecular Formula: C12H22N4O2 Molecular Weight: 254.32868 g/mol Inventors Gowan David Mc, Pierre Jean-Marie Bernard Raboisson, Werner Embrechts, Tim Hugo Maria Jonckers, Stefaan Julien Last, Serge Maria Aloysius Pieters, Jaromir Vlach,  Applicant Janssen R&D Ireland   (3S)-3-[(2-amino-5-methoxypyrimidin-4-yl)amino]heptan-1-ol Mark Hicken, …