Company Product Description Indication Status
Eli Lilly and Co., of Indianapolis Cyramza (ramucirumab) Anti-VEGFR2 mAb Non-small-cell lung cancer European Commission's CHMP issued a positive opinion, recommending label update to support use, in combination with erlotinib, for the first-line treatment of adults with metastatic NSCLC with activating EGFR mutations
Genmab A/S, of Copenhagen, Denmark and Janssen Biotech Inc. Darzalex (daratumumab) CD38-targeting monoclonal antibody Multiple myeloma European Commission's CHMP issued a positive opinion on use in combination with bortezomib, thalidomide and dexamethasone in adults with newly diagnosed disease who are eligible for autologous stem cell transplant
Innovation Pharmaceuticals Inc., of Beverly, Mass. Brilacidin Defensin peptidomimetic Ulcerative colitis U.K.'s MHRA granted the company approval to start phase I trial to investigate the use of delayed-release tablets for colonic delivery of brilacidin in healthy volunteers
Intercept Pharmaceuticals Inc., of New York Obeticholic acid Farnesoid X receptor agonist Non-alcoholic steatohepatitis Submitted its MAA to the EMA for obeticholic acid for the treatment of fibrosis due to NASH; FDA tentatively scheduled adcom for NDA on 4/20/2020, implying extension of March 26 PDUFA date
Janssen Pharmaceutical Companies, of Beerse, Belgium Erleada (apalutamide) Androgen receptor antagonist  Hormone dependent prostate cancer European Commission's CHMP issued a positive opinion on expanding the use of Erleada to include the treatment of adult men with metastatic hormone-sensitive prostate cancer in combination with androgen deprivation therapy
Novartis AG, of Basel, Switzerland Beovu (brolucizumab) VEGF-A ligand inhibitor Wet age-related macular degeneration European Commission's CHMP adopted a positive opinion for use in the treatment of wet age-related macular degeneration
Pfizer Inc., of New York Xeljanz XR (tofacitinib) Janus kinase inhibitor Ulcerative colitis  FDA approved the extended-release 11-mg and 22-mg tablets for once-daily treatment of adult patients with moderately to severely active ulcerative colitis after an inadequate response or intolerance to TNF blockers
Pfizer Inc., of New York Vyndaqel (tafamidis) Oral transthyretin stabilizer Wild-type or hereditary transthyretin amyloidosis  European Commission's CHMP recommended the approval of a once-daily 61 mg oral capsule
Sarepta Therapeutics Inc., of Cambridge, Mass. Vyondys 53 (golodirsen) Antisense oligonucleotide Duchenne muscular dystrophy patients with a confirmed mutation amenable to exon 53 skipping FDA approved 

Notes

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

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