Ipsen and its Partner Exelixis Receive Positive CHMP Opinion for Cabometyx™ (Cabozantinib) for the Treatment of Advanced RCC in Adults Following Prior VEGF-Targeted Therapy
Exelixis, Inc. (NASDAQ:EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA) provided a positive opinion for Cabometyx™ (cabozantinib) 20, 40, 60mg for the treatment of advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy and recommended it for marketing authorization. The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
Evolva’s nootkatone enters NIH-sponsored studies to assess its effectiveness against mosquitoes that transmit Zika virus
REINACH, Switzerland--(EON: Enhanced Online News)--Evolva (SIX:EVE) announces that the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), will sponsor studies to test Evolva’s nootkatone against mosquitoes infected with Zika virus. The study will evaluate nootkatone in multiple formulations against wild type and insecticide-resistant mosquitoes that carry the virus.
ONIVYDE® Receives Positive CHMP Opinion for Treatment of Patients with Metastatic Adenocarcinoma of the Pancreas Who Have Progressed Following Gemcitabine Based Therapy
The positive opinion is based on a pivotal Phase 3 study showing that ONIVYDE combined with chemotherapy significantly increased overall survival (OS) in patients with metastatic pancreatic cancer after previous gemcitabine based therapyShire plc (LSE: SHP, NASDAQ: SHPG) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the marketing authorization for the use of ONIVYDE® (irinotecan pegylated liposomal formulation) also known as nal-IRI or MM-398, for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil (5-FU) and leucovorin (LV), in adult patients who have progressed following gemcitabine based therapy.
RNewswire/ -- Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for ONIVYDE® (irinotecan liposome injection), also known as "nal-IRI", in combination with fluorouracil (5-FU) and leucovorin for the treatment of patients with metastatic pancreatic adenocarcinoma who have progressed after gemcitabine-based therapy.
PRNewswire/ -- ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular") (NYSE MKT: IMUC) today reported progress in its two lead cancer immunotherapy clinical programs: the phase 3 registrational trial of ICT-107 for newly diagnosed glioblastoma and the phase 1 trial of ICT-121 for recurrent glioblastoma.In the ICT-107 phase 3 registrational trial, as of July 21, 2016, 109 patients have been screened in the US and Canada, with plans to randomize qualifying patients once they have completed standard of care and are re-screened (patients randomized in the trial are treated approximately 90 days following initial screening). In addition, clinical supplies (ICT-107 and placebo) for 12 patients have been manufactured. ImmunoCellular also reported that 56 clinical sites in the US and two sites in Canada have been activated, representing almost half the total number of the planned 120 sites for the trial.
A new study published in the British Journal of Dermatology has shown that, on average, 70% of eczema patients are colonised with Staphylococcus aureus bacteria (S. aureus, including MRSA) on their skin lesions. Patients with more severe disease had a greater risk of being colonised. These results provide an indication of the importance of colonisation as a possible trigger in eczema.
Medtronic Unveils VariLoc Variable Angle Locking Technology for Treatment of Fractures
Medtronic plc (NYSE: MDT) today announced the global launch of VariLoc Locking Compression Plate System in China and other select countries. With the innovative variable angle locking technology, the system enables surgeons to adapt screw angulations to patient anatomy, capture fracture fragments, fine-tune screw trajectory after plate placement, and position screws precisely to avoid unnecessary penetration of the nearby joints. The VariLoc system is being launched on a country-by-country basis in 2016, beginning with China, Chile, Kenya, Pakistan, Lithuania, Greece, Poland, Turkey, Thailand, and Vietnam. Launches in additional markets are expected in the coming months, pending local approvals. The VariLoc system is not available for sale in the United States.