Clinical Intelligence

FDA grants QIDP, Fast Track Designations to MCB3837

Tuesday, July 26, 2016

Morphochem, a clinical-stage pharmaceutical company, has announced that the FDA has designated Morphochem’s intravenous (IV) antibacterial product candidate MCB3837 as a Qualified Infectious Disease Product (QIDP) for the treatment of Clostridium difficile infection (CDI). At the same time, the FDA has granted Fast Track designation to the compound’s development program for the treatment of CDI. MCB3837 is the IV prodrug of MCB3681, an antibacterial targeted at the treatment of CDI, which is a serious and potentially fatal disease regarded as an urgent healthcare threat.

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Puma Biotech submits NDA to FDA for PB272

Monday, July 25, 2016

Puma Biotechnology, a biopharmaceutical company, has submitted a New Drug Application (NDA) to the FDA for its lead product candidate PB272 (neratinib) for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy.

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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.

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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.

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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.

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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.

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