Drugs in the Pipeline

Neratinib Demonstrates Potential in Breast Cancer Trial

Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer.

FDA Accepts sBLA, Grants Priority Review for Avastin in Ovarian Cancer

The FDA grants Genentech's sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.

Status Epilepticus Therapy Granted Fast Track Status

The FDA has designated Fast Track status to SAGE-547 (SAGE Therapeutics) for the treatment of adult patients with refractory status epilepticus who have not responded to standard regimens.

RG-102 Desginated Orphan Drug for Alport Syndrome

The FDA has granted Orphan Drug designation to RG-012 (Regulus), a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 for the treatment of Alport syndrome.

Positive Phase 3 Results in Secondary Hyperparathyroidism with AMG 416

Positive Phase 3 results announced for AMG 416 (Amgen) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD), receiving hemodialysis.

Eylea Efficacious in Diabetic Macular Edema Trial

Regeneron announced results from its Phase 3 VIVID-DME trial of Eylea (afilbercept) injection for the treatment of diabetic macular edema (DME).

FDA Designates Antifungal Agent QDIP Status

The FDA has designated isavuconazole (Astellas) as a Qualified Infectious Disease Product (QDIP) for the treatment of invasive candidiasis.

Nintedanib Granted Breakthrough Therapy for Idiopathic Pulmonary Fibrosis

The FDA has granted Breakthrough Therapy designation to Boehringer Ingelheim's nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).

Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B

Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B

Pfizer announced positive results of a Phase 3 study comparing BeneFIX Coagulation Factor IX (Recombinant) to on-demand treatment in patients with moderately severe to severe hemophilia B.

Olysio + Sofosbuvir sNDA Designated Priority Review

The FDA has designated Priority Review to the supplemental New Drug Application (sNDA) for Olysio (simeprevir) in combination with sofosbuvir for 12 weeks of treatment in adults with genotype 1 chronic hepatitis C.

FDA Accepts NDA Resubmission for PA32540/PA8140

The FDA has accepted for review Pozen's resubmitted New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.

Octagam 10% Approved for Platelet Disorder

The FDA has approved Octagam 10% [Immune Globulin Intravenous (Human)] liquid preparation for the treatment of adults with chronic immune thrombocytopenic purpura (ITP).

Priority Review, sBLA Granted for Cervical Cancer Tx

The FDA has accepted Genentech's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

Methylphenidate XR-ODT Effective in Phase 3 ADHD Study

Neos Therapeutics announced the completion of a positive Phase 3 study for its investigational methylphenidate XR-ODT (NT-0102) drug candidate in children with Attention Deficit/Hyperactivity Disorder (ADHD).

Albuterol MDPI NDA Accepted for Review for Bronchospasms

The FDA has accepted for review Teva's New Drug Application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI) for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB) both in patients ≥12 years of age.