Company |
Product |
Description |
Indication |
Status |
Date |
Alteogen Inc., of Daejeon, South Korea |
ALT-P7 |
Antibody-drug conjugate using a trastuzumab variant form of antibody |
Gastric cancer |
FDA granted orphan designation |
8/6/18 |
Ascletis Bioscience Co. Ltd., of Hangzhou, China |
Ravidasvir |
NS5A inhibitor |
Hepatitis C |
Filed a new drug application with the China FDA for use in combination with Ganovo |
7/31/18 |
Ascletis Pharma Inc., of Hangzhou, China |
Ravidasvir |
NS5A inhibitor |
Hepatitis C virus |
China's CNDA accepted the NDA for ravidasvir in combination with previously approved NS3/4A protease inhibitor Ganovo for an all-oral, interferon-free HCV regimen |
8/1/18 |
Daiichi Sankyo Co. Ltd., of Tokyo |
Quizartinib |
FLT3 inhibitor |
Relapsed/refractory FLT3-ITD acute myeloid leukemia |
FDA granted breakthrough therapy designation |
8/1/18 |
Eisai Co. Ltd., of Tokyo, and Merck & Co. Inc., of Kenilworth, N.J. |
Lenvima (lenvatinib) |
VEGFR1, VEGFR2 and VEGFR3 kinase inhibitor |
Second-line or later advanced and/or metastatic non-microsatellite instability high/proficient mismatch repair endometrial carcinoma |
FDA granted breakthrough designation for use with Keytruda (pembrolizumab) |
7/31/18 |
Gilead Sciences Inc., of Foster City, Calif. |
Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg) |
HIV-1 integrase strand transfer inhibitor/CYP inhibitor/HIV nucleoside analogue reverse transcriptase inhibitor/acyclic phosphonate analogue |
HIV-1 infection |
Approved by the China National Drug Administration for adults and adolescents, ages 12 and older, infected with HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir |
8/6/18 |
Helsinn Healthcare SA, of Lugano, Switzerland |
Akynzeo (netupitant/palonosetron) |
NK1 receptor antagonist and 5-HT3 receptor antagonist |
Nausea and vomiting associated with highly or moderately emetogenic cancer chemotherapy |
Korean Ministry of Food and Drug Safety approved the drug for use |
7/31/18 |
Immutep Ltd., of Sydney |
Eftilagimod alpha |
LAG-3Ig fusion protein |
Non-small-cell lung carcinoma or head and neck carcinoma |
FDA approved IND for TACTI-002 study testing drug in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) |
7/31/18 |
Ix Biopharma Ltd., of Singapore |
Silcap (formerly Xcalibur) |
Sildenafil delivered via oral capsule |
Erectile dysfunction |
Approved by Australia's Therapeutic Goods Administration |
8/6/18 |
Otsuka Pharmaceutical Co. Ltd., of Tokyo |
Jinarc (tolvaptan) |
Selective vasopressin-2 receptor antagonist |
Chronic kidney disease stage IV autosomal dominant polycystic kidney disease |
European Commission approved label extension to include stage IV based on data from the REPRISE study |
8/2/18 |
Shionogi & Co. Ltd., of Osaka, Japan |
Mulpleta (lusutromb-opag) |
Once-daily, oral small-molecule thrombopoietin receptor agonist |
Thrombocyto-penia |
Approved under priority review by the FDA for treating adults with chronic liver disease who are scheduled to undergo a procedure |
8/1/18 |
Sumitomo Dainippon Pharma Co. Ltd. and Nitto Denko Corp., both of Osaka, Japan |
Lonasen (blonanserin) |
Atypical antipsychotic |
Schizophrenia |
Submitted new drug application in Japan for a transdermal patch formulation of the drug |
7/31/18 |
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Notes The date indicated refers to the BioWorld Regulatory actions table in which the news item can be found. For more information about individual companies and/or products, see Cortellis. | |||||