Company Product Description Indication Status
Affamed Therapeutics (Shanghai) Co. Ltd., of Shanghai AMT-901 Biosimilar for Herceptin (trastuzumab) HER2-positive breast cancer China National Medical Products Administration approved the CTA for a phase III study
Arrowhead Pharmaceuticals Inc., of Pasadena, Calif ARO-HIF2 RNAi targeting HIF-2alpha Clear cell renal cell carcinoma Submitted IND to FDA for phase Ib study
Avenue Therapeutics Inc., of New York I.V. tramadol Targets mu receptors Moderate to moderately severe pain Submitted NDA to FDA
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C. Berotralstat (BCX-7353) Kallikrein inhibitor Hereditary angioedema attack prophylaxis Submitted NDA to FDA
Correvio Pharma Corp., of Vancouver, British Columbia Brinavess  Antiarrhythmic  Atrial fibrillation FDA’s Cardiovascular and Renal Drugs Advisory Committee voted that the benefit-risk profile was not adequate to support approval with 2 yes votes and 11 no votes
Daré Bioscience Inc., of San Diego, and Strategic Science & Technologies LLC, of Cambridge, Mass. Sildenafil Cream Phosphodiesterase type 5 inhibitor Female sexual arousal disorder Reached alignment with the FDA on patient-reported outcome instruments to be used in a phase IIb study that’s scheduled to start in 2020
Ix Biopharma Ltd., of Singapore Wafermine Sublingual ketamine wafer Acute moderate to severe pain Company and FDA reached agreement on key aspects of the phase III program during an end-of-phase-II meeting; phase III program will consist of a study in pain associated with bunionectomy and a second study in pain after abdominoplasty; primary endpoint for both studies is summed pain intensity difference over 12 hours
Novartis AG and Roche Holding AG, both of Basel, Switzerland Xolair (omalizumab) Monoclonal antibody targeting immunoglobulin E Nasal polyps FDA accepted supplemental BLA; PDUFA date in the third quarter of 2020

Notes

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

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