Company Product Description Indication Status
Abeona Therapeutics Inc., of New York and Cleveland ABO-102 Adeno-associated virus 9 gene therapy Sanfilippo syndrome type A (MPS IIIA) EMA granted PRIME designation to ABO-102 program studying its adeno-associated virus 9 gene therapy for
Amgen Inc., of Thousand Oaks, Calif., and Allergan plc, of Dublin ABP-798 Biosimilar candidate to Rituxan (rituximab), a CD20-directed cytolytic antibody Non-Hodgkin's lymphoma, in combination with fludarabine and cyclophosphamide for chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis with glucocorticoids BLA submitted to FDA
Bridge Biotherapeutics Inc., of Seongnam, South Korea BBT-176 Epidermal growth factor receptor - tyrosine kinase inhibitor Lung cancer IND submitted to FDA and Ministry of Food and Drug Safety in Korea
Bristol-Myers Squibb Co., of Princeton, N.J. Revlimid (lenalidomide) Immunomodulatory agent Adult patients with previously treated follicular lymphoma (grade 1-3a) EC approved a new indication for Revlimid in combination with rituximab
Galderma SA, of Lausanne, Switzerland Aklief (trifarotene 50 mcg/g cream) Retinoid molecule Acne vulgaris of the face and/or the trunk in patients from 12 and older Concluded European decentralised procedure resulting in the approval of product characteristics, package leaflet and labeling by all involved European member states; the 16 member states will now issue individual national marketing authorizations
Gilead Sciences Inc., of Foster City, Calif. Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100 mg) HCV NS3 protease inhibitor, polymerase inhibitor and protein NS5A inhibitor Chronic HCV infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral therapy Approved by China's NMPA
Gilead Sciences Inc., of Foster City, Calif. Filgotinib Oral, selective JAK1 inhibitor Moderate-to-severe rheumatoid arthritis NDA submitted to FDA accompanied by a priority review voucher
Hutchison China Meditech Ltd. Surufatinib (previously known as HMPL-012 or sulfatinib) Oral angio-immuno kinase inhibitor Advanced non-pancreatic neuroendocrine tumors Center for Drug Evaluation of China’s NMPA granted priority review status for the NDA
Macrogenics Inc., of Rockville, Md. Margetuximab Fc-engineered, monoclonal antibody that targets HER2 Metastatic HER2-positive breast cancer Submitted BLA for margetuximab in combination with chemotherapy
Merck & Co. Inc., of Kenilworth, N.J. Ervebo Ebola Zaire Vaccine, Live Zaire ebolavirus FDA approved to prevent the disease in people 18 years and older
Merck & Co. Inc., of Kenilworth, N.J. Keytruda (pembrolizumab) Anti-PD-1 therapy Renal cell carcinoma, recurrent or distant metastatic head and neck cancer Approved by Japan's PMDA for 3 first-ine indications
Nabriva Therapeutics plc, of Dublin Contepo (fosfomycin) IV investigational antibiotic Complicated urinary tract infections, including acute pyelonephritis Resubmitted NDA to FDA based on the outcome of a type A meeting with the FDA, which was conducted to obtain clarity on the CRL issued in April 2019
Sunovion Pharmaceuticals Inc., of Marlborough, Mass. Apomorphine sublingual film (APL-130277) Dopamine agonist Motor fluctuations (OFF episodes) associated with Parkinson’s disease FDA accepted NDA; PDUFA data set for 5/21/20

Notes

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

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