Company Product Description Indication Status
Alk-Abello A/S, of Hørsholm, Denmark Standardized allergen extract, white birch (betula verrucosa) sublingual tablet Allergy desensitization vaccine Seasonal allergic rhinitis Health Canada approved once-daily sublingual allergy immunotherapy, branded Itulatek, to treat tree pollen allergy
Bayer AG, of Leverkusen, Germany Vitrakvi (larotrectinib) Tyrosine receptor kinase (TRK) inhibitor Advanced solid tumors NICE recommended approval to treat advanced neurotrophic TRK fusion-positive tumors in adults and children if disease is locally advanced, metastatic or surgery could cause severe health problems and patients have no satisfactory treatment options
Beigene Ltd., of Beijing Tislelizumab PD-1 inhibitor Non-small-cell lung cancer China NMPA's Center for Drug Evaluation accepted sNDA filing to treat, in combination with chemotherapy regimens, first-line advanced squamous disease
Boehringer Ingelheim GmbH, of Ingelheim, Germany Ofev (nintedanib) Tyrosine kinase inhibitor Systemic sclerosis-associated interstitial lung disease EC approved drug to treat adult patients 
Hope Biosciences Inc., of Houston HB-adMSCs Adipose-derived mesenchymal stem cell therapy COVID-19 infection FDA approved phase II study expected to enroll 110 hospitalized participants into 2 arms; those taking and those not taking hydroxychloroquine and azithromycin will be randomized into separate placebo or treatment groups, in addition to standard of care; those treated will receive 4 doses of 100 million HB-adMSCs over 10-day period
Myovant Sciences Ltd., of Basel, Switzerland Relugolix GNRH receptor antagonist Advanced prostate cancer Submitted NDA to FDA for once-daily oral (120 mg) drug
Passage Bio Inc., of Philadelphia PBGM-01 GLB1 gene stimulator Infantile GM1 gangliosidosis FDA granted orphan drug designation


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

No Comments