Drugs in the Pipeline

Drugs in the Pipeline

FDA Accepts Opdivo sBLA for Expanded Indication

The Food and Drug Administration (FDA) has accepted for filing and granted priority review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab, Bristol-Myers Squibb) for the treatment of previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC).

Nuplazid NDA Submitted for Parkinson's Disease Psychosis

Acadia announced it has submitted to the Food and Drug Administration (FDA) a priority review of the New Drug Application (NDA) for Nuplazid (pimavanserin) for the treatment of Parkinson's disease psychosis (PDP).

New HIV Combo Drug Comparable to Standard Tx in Phase 3 Study

Gilead announced that a Phase 3 study evaluating its investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for the treatment of HIV-1 infection met its primary objective.

Top-Line Results for Investigational Osteoporosis Drug

Amgen and UCB announced top-line results from the STRUCTURE trial evaluating romosozumab in women with postmenopausal osteoporosis at high risk for fracture previously treated with bisphosphonate therapy.

Rapid Reversal Seen With Idarucizumab in Pradaxa-Treated Patients

Boehringer Ingelheim presented positive results of its Phase 3 RE-VERSE AD study for idarucizumab as a reversal agent for the anticoagulant effect of Pradaxa (dabigatran) in patients needing emergency surgery or for life-threatening or uncontrolled bleeding events.

Elotuzumab BLA Given Priority Review for Multiple Myeloma

The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Empliciti (elotuzumab, Bristol-Myers Squibb/AbbVie) for the treatment of multiple myeloma as combination therapy in patients who have received one or more prior therapies.

Biologic Tx BLA Accepted for Bladder Cancer

The Food and Drug Administration (FDA) has accepted for filing the Biologics License Application (BLA) for MCNA (Telesta) as a therapeutic alternative to surgery in high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy.

Letairis/Tadalafil Combo Demonstrates Efficacy for Pulmonary HTN

Gilead Sciences announced positive results from the AMBITION study, a Phase 3/4 trial of first-line combination therapy with Letairis (ambrisentan) and tadalafil in patients with WHO/NYHA functional class II and III pulmonary arterial hypertension (PAH).

Novel Antibiotic Fast Tracked for Bacterial Vaginosis

The Food and Drug Administration (FDA) has granted SYM-1219 (secnidazole, Symbiomix) Fast Track designation for the treatment of bacterial vaginosis (BV).

FDA Accepts Eteplirsen NDA for Duchenne Muscular Dystrophy

The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for eteplirsen (Sarepta) for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.