Drugs in the Pipeline

Ilaris Granted 3 Breakthrough Designations for Rare Types of Periodic Fever Syndromes

Ilaris Granted 3 Breakthrough Designations for Rare Types of Periodic Fever Syndromes

Novartis announced that the Food and Drug Administration (FDA) have granted Ilaris (canakinumab) three Breakthrough Therapy Designations, to treat three types of rare Periodic Fever Syndromes (also known as Hereditary Periodic Fevers).

Promising Results in Phase 3 Trials for Nebulized Glycopyrrolate in COPD

Promising Results in Phase 3 Trials for Nebulized Glycopyrrolate in COPD

Sunovion Pharmaceuticals announced positive data from its Phase 3 study of SUN-101 (glycopyrrolate), to treat people with moderate-to-very severe chronic obstructive pulmonary disease (COPD).

FDA Grants Opdivo New Breakthrough Therapy Status

FDA Grants Opdivo New Breakthrough Therapy Status

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo (nivolumab), to potentially treat recurrent or metastic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy.

Nplate Demonstrates Efficacy in Pediatric ITP

Nplate Demonstrates Efficacy in Pediatric ITP

Amgen announced published results from a Phase 3 study of Nplate (romiplostim) for the treatment of symptomatic immune thrombocytopenia (ITP) in children. Study data were published in The Lancet.

Novel Chronic Idiopathic Constipation Drug Under FDA Review

Novel Chronic Idiopathic Constipation Drug Under FDA Review

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for plecanatide (Synergy) for the treatment of chronic idiopathic constipation (CIC).

First Long-Acting Buprenorphine Implant Shows Promise for Opioid Addiction

First Long-Acting Buprenorphine Implant Shows Promise for Opioid Addiction

Braeburn Pharmaceuticals announced positive data from the Phase 3 study of Probuphine (buprenorphine subdermal implant) for the long-term maintenance treatment of opioid addiction. Findings were presented at the 47th Annual American Society of Addiction Medicine (ASAM) Conference.

New Formulation of Vyvanse Submitted to FDA for Review

New Formulation of Vyvanse Submitted to FDA for Review

Shire announced that it has submitted to the Food and Drug Administration (FDA) a New Drug Application (NDA) for a new, alternate formulation of Vyvanse (lisdexamfetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule.

FDA Grants Keytruda Fourth Breakthrough Therapy Status

FDA Grants Keytruda Fourth Breakthrough Therapy Status

The FDA has granted Keytruda (pembrolizumab) its fourth Breakthrough Therapy designation for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Pan-Genotypic HCV Regimen Shows Promise in Trial

Pan-Genotypic HCV Regimen Shows Promise in Trial

AbbVie announced positive results from the ongoing MAGELLAN-1 study, evaluating the efficacy, safety, and pharmacokinetics of ABT-493 and ABT-530, with and without RBV, for the treatment of genotype 1 (GT1) and genotypes 4-6 chronic hepatitis C virus (HCV) infection in non-cirrhotic adults who failed previous therapy with direct-acting antivirals (DAA).

Triple-Bead Mixed Amphetamine Salts Shows Promise in ADHD Study

Triple-Bead Mixed Amphetamine Salts Shows Promise in ADHD Study

Shire announced positive topline results from the Phase 3 study, SHP465-305, evaluating SHP465 (triple-bead mixed amphetamine salts - MAS) in children and adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD).

Positive Results Announced for Dupilumab in Atopic Dermatitis Studies

Positive Results Announced for Dupilumab in Atopic Dermatitis Studies

Regeneron and Sanofi announced that the two Phase 3 studies, LIBERTY AD SOLO 1 and SOLO 2, evaluating dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD), met their primary endpoints.

FDA to Review Remoxy NDA for Pain Management

FDA to Review Remoxy NDA for Pain Management

Durect and its licensee, Pain Therapeutics, announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Remoxy (extended-release oxycodone).

Orphan Drug Status Granted to Inhaled Antimicrobial Agent Mul-1867

Orphan Drug Status Granted to Inhaled Antimicrobial Agent Mul-1867

The FDA has granted Orphan Drug designation to Mul-1867 (TGV-Inhalonix) for the treatment of antibiotic-resistant bacterial lung infections in patients with cystic fibrosis.

Reformulated Metronidazole Granted Orphan Drug for CDI in Children

Reformulated Metronidazole Granted Orphan Drug for CDI in Children

Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.

Palatable CDI Tx for Children Designated Orphan Drug Status

Palatable CDI Tx for Children Designated Orphan Drug Status

Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.