Company Product Description Indication Status
Astellas Pharma Inc., of Tokyo Xtandi (enzalutamide) Oral androgen receptor signaling inhibitor Prostate tumor Japan Ministry of Health, Labour and Welfare approved drug for the treatment of prostate cancer patients with distant metastasis
Boehringer Ingelheim International GmbH Ofev (nintedanib) Tyrosine kinase inhibitor Interstitial lung disease EMA's Committee for Medicinal Products for Human Use issued positive opinion for treatment of adults with other chronic fibrosing interstitial lung diseases with a progressive phenotype beyond idiopathic pulmonary fibrosis
Eli Lilly and Co., of Indianapolis Tauvid (flortaucipir F18 Radioactive diagnostic agent Alzheimer's disease FDA approved for PET imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles in adults with cognitive impairment being evaluated for AD
Hutchison China Meditech Ltd. (Chi-Med), of Hong Kong Savolitinib MET inhibitor Non-small-cell lung cancer  NDA for NSCLC with MET exon 14 skipping mutations accepted for review by China's NMPA
Immune-Onc Therapeutics, Inc., of Palo Alto, Calif. IO-202 Leukocyte Ig-like receptor-4 antagonist Acute myeloid leukemia; chronic myelomonocytic leukemia FDA approved IND for phase I dose-escalation study in AML patients with monocytic differentiation and CMML patients
Johnson & Johnson, of New Brunswick, N.J.  Zabdeno (Ad26.Zebov) + MVABEA (MVA-BN-Filo) Prime‐boost vaccine regimen Ebola virus infection EMA's Committee for Medicinal Products for Human Use issued positive opinion
Menlo Therapeutics Inc., of Bridgewater, N.J. Zilxi (minocycline, formerly Foamix) Tetracycline antibiotic Rosacea Approved by FDA
Nabriva Therapeutics Inc., of Dublin Xenleta (lefamulin) Semisynthetic pleuromutilin antibiotic  Community-acquired pneumonia EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval 
Novartis AG, of Basel, Switzerland Piqray (alpelisib) Kinase inhibitor Metastatic breast cancer EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval 
Onxeo SA, of Paris Asidna DDR inhibitor Relapsed ovarian cancer French National Agency approved phase Ib/II study
Orphazyme A/S, of Copenhagen, Denmark Arimoclomol Heat-shock protein amplifier Niemann-Pick disease type C Started submission of NDA
Roche Holding AG, of Basel, Switzerland Rozlytrek (entrectinib)  Targets NTRK1/2/3 or ROS1 gene fusions Solid tumors EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval 
Santhera Pharmaceuticals AG, of Pratteln, Switzerland Puldysa (idebenone) Short-chain benzoquinone and a cofactor for the enzyme NAD(P)H:quinone oxidoreductase Duchenne muscular dystrophy EMA's Committee for Medicinal Products for Human Use requested extension of the clock-stop in the regulatory procedure for the conditional marketing authorization 
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Takhzyro (lanadelumab) Fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity Hereditary angioedema EMA's Committee for Medicinal Products for Human Use adopted positive opinion recommending approval

Notes

For more information about individual companies and/or products, see Cortellis.

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