Tag «FDA 2016»

Talazoparib, MDV3800

It’s only fair to share… Talazoparib, BMN-673, MDV-3800 (2S,3S)-methyl-7-fluoro-2-(4-fluorophenyl)-3-(1-methyl-1H-1,2,4-triazol-5-yl)-4-oxo-1,2,3,4-tetrahydroquinoline-5-carboxylate (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one CAS 1207456-01-6 Chemical Formula: C19H14F2N6O Exact Mass: 380.11972 BMN673, BMN673, BMN-673, LT673, LT 673, LT-673,  Talazoparib BioMarin Pharmaceutical Inc phase 3 Poly ADP ribose polymerase 2 inhibitor; Poly ADP ribose polymerase 1 inhibitor cancer (85,9R)-5-fluoro-8-(4-fluorophenyl)-9-(l-methyl-lH-l,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one toluenesulfonate salt CAS 1373431-65-2(Talazoparib Tosylate) 1H NMR DMSOD6 13C NMR DMSOD6 HMBC …

Lifitegrast

It’s only fair to share… Lifitegrast, SAR 1118 SAR-1118-023 CAS 1025967-78-5 Xiidra (lifitegrast ophthalmic solution) FDA approves new medication for dry eye disease 07/12/2016 08:48 AM EDT The U.S. Food and Drug Administration approved Xiidra (lifitegrast ophthalmic solution) for the treatment of signs and symptoms of dry eye disease, on Monday, July 11, 2016. Xiidra …

FDA grants accelerated approval to new treatment for advanced ovarian cancer , Rubraca(rucaparib)

It’s only fair to share… The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious …

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 …

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) …