Drugs in the Pipeline

Alvocidib Designated Orphan Drug in AML

The FDA has granted Orphan Drug designation to alvocidib (Tolero Pharmaceuticals) for the treatment of patients with acute myeloid leukemia (AML).

Tofacitinib Meets Endpoints in Two Phase 3 Psoriasis Trials

Pfizer announced top-line results from two pivotal Phase 3 trials, evaluating the efficacy and safety of Xeljanz (tofacitinib) for the treatment of moderate-to-severe plaque psoriasis.

NDA Submitted for All-Oral, Interferon-Free Hepatitis C Regimen

AbbVie has submitted a New Drug Application (NDA) to the FDA for an investigational, all-oral, interferon-free regimen for the treatment of adults with chronic genotype (GT1) hepatitis C virus (HCV) infection.

FDA Accepts Two NDAs for HIV Therapy

The FDA has accepted Gilead's New Drug Applications (NDAs) for cobicistat and elvitegravir for the treatment of HIV-1 infection in treatment-experienced adults.

Eteplirsen NDA Submission Plans for Rare Neuromuscular Disorder

Sarepta Therapeutics has announced its plans to submit a New Drug Application (NDA) for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

Anthrax Vaccine Designated Orphan Drug for Post-Exposure Prophylaxis

The FDA has granted Orphan Drug designation to BioThrax (Anthrax Vaccine Adsorbed; Emergent BioSolutions) for post-exposure prophylaxis (PEP) of anthrax disease resulting from suspected or confirmed exposure to Bacillus anthracis.

Cubist Submits NDA for Combination Antibiotic

Cubist announced that it has submitted a New Drug Application (NDA) to the FDA for its investigational antibiotic, ceftolozane/tazobactam for the treatment of Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI).

Volasertib Designated Orphan Drug for Acute Myeloid Leukemia

The FDA has granted Orphan Drug designation to volasertib (Boehringer Ingelheim) for acute myeloid leukemia (AML).

Otrexup Results Published for Rhuematoid Arthritis

Antares Pharma announced the publication of results from its crossover study comparing the relative bioavailability, safety, and tolerability of Otrexup (methotrexate) to oral methotrexate (MTX) in adults with rheumatoid arthritis in the Annals of the Rheumatic Diseases.

AbbVie Launches Veliparib Trial for NSCLC

AbbVie announced the initiation of a Phase 3 trial evaluating the safety and efficacy of veliparib (ABT-888) in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).