Pharma News

Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Afinitor® (everolimus) tablets for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. If approved by the European Commission (EC), Afinitor would address an unmet need as there are currently few or no treatment options in Europe for patients with these diseases.

AbbVie announced that it will acquire Stemcentrx and its lead late-stage asset rovalpituzumab tesirine (Rova-T) currently in registrational trials for small cell lung cancer (SCLC). Rova-T is a novel biomarker-specific therapy that is derived from cancer stem cells and targets delta-like protein 3 (DLL3) that is expressed in more than 80 percent of SCLC patient tumors and is not present in healthy tissue. Registrational trials for third-line small cell lung cancer are expected to complete enrollment by the end of 2016.
In Phase 1/2 studies of relapsed SCLC patients who have previously failed one or more standard therapies, Rova-T demonstrated overall response rates of 44 percent in the patients identified with high expression of DLL3. The expression of DLL3 suggests Rova-T also may be useful across multiple tumor types, including metastatic melanoma, glioblastoma multiforme, prostate, pancreatic and colorectal cancers, where DLL3 expression ranges from 50-80 percent. Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimizing toxicity to healthy cells.

Advaxis, Inc. announced that the Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s immunotherapy product candidate ADXS-HER2 for patients with newly-diagnosed, non-metastatic, surgically-resectable osteosarcoma.

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Adapalene and Benzoyl Peroxide Gel, 0.1%|2.5%, the generic version of Epiduo® Gel of Galderma Laboratories L.P.

Hilleman Laboratories, a first-of-its-kind joint-venture between Merck Sharp & Dohme (MSD) and the Wellcome Trust, announced the initiation of Phase I/II clinical trial of its innovative vaccine, an oral, lyophilized, heat-stable Rotavirus vaccine, against Rotavirus disease.

Accuray Incorporated, a radiation oncology company, announced the submission of its 510(k) premarket notification with the Food and Drug Administration (FDA) for the company’s Radixact Treatment Delivery System. Accuray also submitted 510(k) premarket notification for its treatment planning and data management systems, Precision Treatment Planning System and iDMS Data Management System.

ChemoCentryx, Inc., announced that the U.S. Food and Drug Administration (FDA) has awarded the Company a one-year grant of $500,000 to assist in the clinical development of CCX168, the Company's lead drug candidate for the treatment of patients with anti-neutrophil cytoplasmic antibody (ANCA) -associated vasculitis, or AAV. CCX168 is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR.

OPKO Health, Inc. announced the U.S. Food and Drug Administration (FDA) has accepted OPKO's resubmission on April 22, 2016 of the New Drug Application (NDA) for RAYALDEE® (calcifediol) for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.