Drugs in the Pipeline

Three-Month Paliperidone Palmitate NDA Granted Priority Review

The Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate (Janssen R&D) to treat schizophrenia in adults.

Deflazacort Designated Fast Track Status for Duchenne Muscular Dystrophy

The Food and Drug Administration (FDA) has granted Fast Track designation to deflazacort (Marathon Pharmaceuticals) for the treatment of patients with Duchenne Muscular Dystrophy (DMD).

Acute Myeloid Leukemia Therapy Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track status to CPX-351 (cytarabine:daunorubicin; Celator Pharmaceuticals) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

Phase 2/3 Study Data Announced for Vectibix in Colorectal Cancer

Amgen announced new data from its PEAK and PRIME studies that support Vectibix (panitumumab), in combination with FOLFOX, as first-line therapy in patients with wild-type RAS metastatic colorectal cancer (mCRC)

Treximet sNDA Accepted by FDA for Adolescent Migraine

Treximet sNDA Accepted by FDA for Adolescent Migraine

Pernix announced that the sNDA for Treximet (sumatriptan/naproxen sodium) for use in adolescents aged 12-17 years for the acute treatment of migraine with or without aura has been accepted by the FDA.

Oral HIV Vaccine Undergoing Testing

Oral HIV Vaccine Undergoing Testing

A new oral vaccine to prevent HIV infection that does not contain the HIV virus is currently being tested in clinical trials at the University of Rochester Medical Center.

Sparsentan Gains Orphan Drug Designation for Rare Nephropathy

The Food and Drug Administration (FDA) has granted orphan drug designation for Retrophin's sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).

Novel Antibiotic Debio 1450 Designated Fast Track Status

Debiopharm announced that the Food and Drug Administration (FDA) has granted Fast Track designation for Debio 1450, an antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Positive Results for Elagolix in Endometriosis Study

AbbVie announced positive results from one of two ongoing Phase 3 trials for elagolix in premenopausal women with endometriosis.

Cutaneous T-Cell Lymphoma Tx Designated Fast Track

Soligenix announced that the FDA has granted a Fast Track designation for SGX301 (synthetic hypericin) for the first-line treatment of cutaneous T-cell lymphoma.

Positive Safety, Tolerability Data for ALKS 5461 in MDD Study

Alkermes announced positive results for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).

Spectrum Submits NDA for Propylene Glycol-Free Melphalan

Spectrum Submits NDA for Propylene Glycol-Free Melphalan

Spectrum announced the submission of an NDA for Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) for use as high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma, and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

NDA Submitted for Buprenorphine Buccal Film for Pain

Endo and BioDelivery Sciences announced the submission of an NDA for buprenorphine HCl buccal film to the FDA for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Safinamide NDA Resubmitted for Parkinson's Disease

Newron announced the resubmission of its NDA for safinamide to the FDA.

BAX111 BLA Submitted for von Willebrand Disease

BAX111 BLA Submitted for von Willebrand Disease

Baxter announced that it has submitted a biologics license application (BLA) to the Food and Drug Administration (FDA) for BAX111, the first recombinant von Willebrand Factor (rVWF) for patients with von Willebrand disease.