News

Lymphoseek (Navidea) success in Head and Neck cancer trial

Navidea Biopharmaceuticals, Inc. announced top-line results from the interim analysis of its Phase III clinical trial, NEO3-06, of Lymphoseek (technetium 99m tilmanocept) Injection in patients with head and neck squamous cell carcinoma. Results of the pre-planned interim analysis demonstrated that Lymphoseek met the primary efficacy endpoint of accurately identifying sentinel lymph nodes (SLNs) in subjects with squamous cell carcinoma ...

FDA approves Karbinal ER (Tris Pharma) for Allergic Rhinitis

The FDA has on 3 April 2013 approved a New Drug Application (NDA) for Karbinal ER (carbinoxamine maleate) Extended-release Oral Suspension 4mg/5ml, from Tris Pharma, being the first sustained-release histamine receptor blocking agent indicated for the treatment of seasonal and perennial Allergic Rhinitis in children ages 2 and up.

Prior to 2006, carbinoxamine was widely used, with dozens of carbinoxamine-containing ...

Dymista(Meda AB) is EU approved via decentralised procedure for Allergic Rhinitis

Dymista (azelastine hydrochloride and fluticasone propionate)from Meda AB has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial Allergic Rhinitis and is now approved by the MHRA in the UK .

National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior ...

Phase II success for AM 111 (Auris Medical) for acute sensorineural hearing loss

Auris Medical has announced positive results from a Phase IIb clinical trial with AM-111, its investigational drug for the intratympanic (i.t.) treatment of acute sensorineural hearing loss (ASNHL). The study demonstrated that the treatment was well tolerated and showed a statistically significant and clinically relevant treatment effect.

The double-blind, randomized, placebo-controlled phase IIb study with AM-111 involved a total ...

Zetonna (Sunovion) launched in US for Allergic Rhinitis

Sunovion Pharmaceuticals Inc. announced the nationwide US availability of Zetonna (ciclesonide) Nasal Aerosol, 74 mcg once-daily, for the treatment of allergic rhinitis (AR), also known as hay fever or nasal allergies. Zetonna is a corticosteroid indicated for the treatment of symptoms associated with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age ...

Two Phase III studies of OMS ElectroChemotherapy (OncoSec Medical) show QoL benefits

Data from an interim analysis of two Phase III trials, HNBE-01 and HNBE-02, using OMS ElectroChemotherapy, from OncoSec Medical, to treat locally recurrent and second primary squamous cell carcinoma of the head and neck enhances patients quality of life.

In these studies, electrochemotherapy was compared against surgery for quality of life, safety, survival and local control at eight months, ...

FDA approve Dymista (Meda AB) for Seasonal Allergic Rhinitis

The FDA has approved Dymista, from Meda AB, for treatment of Seasonal Allergic Rhinitis. The efficacy and safety of Dymista has been documented in several studies involving over 4,000 patients, including a long-term safety study with more than 600 patients. Dymista will be available in the US during the second half of 2012. The treatment was filed for marketing approval ...

FDA approves Absolute Pro stent system (Abbott) for PAD

The FDA has approved the Absolute Pro Vascular Self-Expanding Stent System, from Abbott, for the treatment of Iliac Artery Disease, a form of Peripheral Artery Disease (PAD) that affects the lower extremities. This approval is supported by the MOBILITY study, which demonstrated that Absolute Pro is safe and effective, even in patients with complex disease. Absolute Pro is a self-expanding ...

Afatinib(Boehringer) enters Phase III trials for Head and Neck Cancer

Afatinib from Boehringer enters Phase III trials for Head and Neck cancer.LUX-Head & Neck 1 and LUX-Head & Neck 2. These trials evaluate Afatinib in patients with metastatic and recurrent head and neck cancer, and in patients with locally advanced disease, respectively....

Avastin (Roche/Genentech) prevents spread of Nasopharyngeal Carcinoma in Phase II trial

Combining Avastin (bevacizumab), from Roche/Genentech, with standard chemoradiation therapy is safe and could prolong survival in patients with advanced Nasopharyngeal Carcinoma, according to a new Phase II trial. The results indicate that Avastin might be more effective at preventing the spread of Nasopharyngeal Carcinoma to other parts of the body, the most common cause of death in patients with advanced ...

Reolysin (Oncolytics) success in Head and Neck Cancer

A trial called, REO 015, was a single arm open-label, study of Reolysin, from Oncyolytics Biotech, which was given intravenously with paclitaxel (175 mg/m2) and carboplatin (AUC 5) every three weeks in patients with platinum-refractory recurrent and/or metastatic squamous cell cancers of the oral cavity, larynx, or pharynx. Findings were presented at the AACR-NCI-EORTC International Conference on Molecular and Cancer ...

FDA approves Erbitux (BMS/Merck-Serono) for metastatic Head and Neck Cancer

The FDA has approved Erbitux (cetuximab), from BMS/Merck-Serono, in combination with platinum-based chemotherapy with 5-fluorouracil, for the first-line treatment of recurrent locoregional or metastatic Head and Neck cancer. The drug is already FDA approved for some colon cancers and non-metastatic Head and Neck Cancer. The latest approval is based on data from the Phase III EXTREME trial which showed that ...