Drugs in the Pipeline

FDA to Review Kyprolis for Relapsed Multiple Myeloma

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.

Three-Month Paliperidone Palmitate to Delay Relapse in Schizophrenia: Phase 3 Data Published

Janssen R&D announced that results from a Phase 3 clinical study with three-month paliperidone palmitate have been published in JAMA Psychiatry.

Orphan Drug Status Granted to Mesothelioma Therapy

Aduro Biotech announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to CRS-207 for the treatment of mesothelioma.

Ebola Vaccine Based on Current Strain Provokes Immune Response in First Phase 1 Trial

Ebola Vaccine Based on Current Strain Provokes Immune Response in First Phase 1 Trial

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.

Non-Alcohol Formula of Docetaxel Injection Submitted for FDA Review

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.

Keytruda Results May Halt Melanoma Trial Early

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.

FDA Lifts Clinical Hold, Tanezumab Trial to be Resumed

Pfizer and Eli Lilly and Company announced that they are preparing to resume the Phase 3 clinical pain program for tanezumab.

New Data Shows Tofacitinib Effective for Plaque Psoriasis

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.

Long-Term Efficacy Data for Otezla in Plaque Psoriasis Announced

Celgene announced results from the ESTEEM Phase 3 clinical program for Otezla (apremilast) in patients with moderate to severe plaque psoriasis.

Combo Acne Drug Reduces Lesion Count in Trial

Galderma announced positive Phase 3 results for adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel.

Orphan Status Granted to Investigational Pulmonary Arterial Hypertension Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to tacrolimus (SPI-026; Selten Pharma) for the treatment of pulmonary arterial hypertension.

Imbruvica Significantly Delays Disease Progression in CLL/SLL Study

Results have been announced from a pre-planned interim analysis of the Phase 3 HELIOS (CLL3001) trial studying the combination of Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) plus bendamustine and rituximab (BR) vs. placebo plus BR in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Novel Anti-Clotting Therapy Trial Permanently Halted Due to AEs

Regado BioSciences announced the permanent hold of the Phase 3 REGULATE-PCI trial in August 2014, which compared Revolixys Kit (pegnivacogin/anivamersen; REG1 Anticoagulation System) to bivalirudin in patients undergoing percutaneous coronary intervention (PCI).

New Data on Novel Investigational Cholesterol Drug, CV Events

New Data on Novel Investigational Cholesterol Drug, CV Events

Amgen announced one-year results from prespecified exploratory endpoints of adjudicated cardiovascular events in the Phase 2 (OSLER-1) and Phase 3 (OSLER-2) open-label extension studies of Repatha (evolocumab) for the treatment of high cholesterol.

BAX 817 for Hemophilia A/B: New Results from Phase 3 Trial

BAX 817 for Hemophilia A/B: New Results from Phase 3 Trial

Baxter announced positive results from a Phase 3 trial evaluating BAX 817 for the treatment of patients with hemophilia A or B who develop inhibitors.