Drugs in the Pipeline
The Food and Drug Administration (FDA) has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib; Amgen) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.
Janssen R&D announced that results from a Phase 3 clinical study with three-month paliperidone palmitate have been published in JAMA Psychiatry.
Aduro Biotech announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to CRS-207 for the treatment of mesothelioma.
Researchers have published results from the first Phase 1 trial of an Ebola vaccine developed based on the 2014 Zaire Guinea Ebola strain in The Lancet.
Teikoku Pharma USA announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Docetaxel Injection Concentrate, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Merck announced results from the Phase 3 KEYNOTE-006 study investigating Keytruda (pembrolizumab) vs. ipilimumab in the first-line treatment of patients with advanced melanoma.
Pfizer and Eli Lilly and Company announced that they are preparing to resume the Phase 3 clinical pain program for tanezumab.
Pfizer announced results from two Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program for tofacitinib citrate in adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Celgene announced results from the ESTEEM Phase 3 clinical program for Otezla (apremilast) in patients with moderate to severe plaque psoriasis.
Galderma announced positive Phase 3 results for adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel.