Clinical Intelligence

Evoke Pharma issues topline results from EVK-001 phase III trial

Thursday, July 21, 2016

Evoke Pharma, a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, has announced topline results from its phase III clinical trial of EVK-001 in female patients with symptomatic diabetic gastroparesis. In this study, EVK-001, the company’s patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women, did not achieve its primary endpoint of symptom improvement at Week 4.

[Read More]

FDA approves BELVIQ XR weight loss tablets

Thursday, July 21, 2016

The FDA has approved Eisai and Arena Pharmaceuticals’ New Drug Application (NDA) for BELVIQ XR (lorcaserin HCl) CIV extended-release 20mg tablets. The new formulation of lorcaserin will offer patients a once-a-day dosing option that may help them achieve and maintain weight loss. BELVIQ XR is expected to be available in the fall of 2016. In connection with the approval, Arena will receive a $10 million milestone payment.

[Read More]

AbbVie receives Rare Pediatric Disease Designation for ABT-414

Tuesday, July 12, 2016

AbbVie, a global biopharmaceutical company, announced that the FDA granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) targeting the epidermal growth factor receptor (EGFR), for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG), known to be highly aggressive and difficult to treat brain tumors found at the base of the brain.

[Read More]

FDA grants Merrimack Fast Track for Seribantumab in lung cancer

Monday, July 11, 2016

Merrimack Pharmaceuticals has announced that the FDA has granted seribantumab, also known as MM-121, Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy. Fast Track is a program designed by the FDA to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.

[Read More]