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NovoCure

Novocure enrolls 1st patient in phase III brain metastases trial

October 12, 2016 By Sarah Faulkner

Novocure (NSDQ:NVCR) said that the 1st patient has been enrolled in a Phase III pivotal trial of its tumor-treating field technology in combination with radiosurgery to treat brain metastases from non-small-cell lung cancer. The St. Helier, N.J.-based company’s tumor treating fields (TTFields) are low-intensity, intermediate-frequency, alternating electric fields designed to disrupt cell division within cancer cells. Novocure’s commercial product, Optune, […]

Filed Under: Clinical Trials, Drug-Device Combinations, Neurological, Oncology Tagged With: NovoCure

Novocure touts long-term analysis of Optune drug-device combo

September 12, 2016 By Sarah Faulkner

Novocure (NSDQ: NVCR) touted a long-term analysis of data from a Phase III pivotal trial of its Optune device in combination with temozolomide for the treatment of newly-formed glioblastomas. Survival data for nearly 700 patients confirmed interim results from the trial, 1st published in December 2015 in the Journal of the American Medical Assn. Patients treated […]

Filed Under: Clinical Trials, Drug-Device Combinations, Radiosurgery/Radiation therapy Tagged With: NovoCure

Novocure touts data from Optune-paclitaxel combination study

September 2, 2016 By MassDevice

By Sarah Faulkner NovoCure (NSDQ:NVCR) announced yesterday that its ‘tumor treating fields, combined with the drug paclitaxel, are effective against ovarian cancer, the 5th most-common cause of cancer death in women in the US. The St. Helier, N.J.-based company won FDA approval in July for the Optune device to treat a type of brain cancer called glioblastoma. TTFields […]

Filed Under: Clinical Trials, Drug-Device Combinations, Oncology Tagged With: NovoCure

NovoCure wins FDA nod for next-gen Optune device

July 14, 2016 By Fink Densford

NovoCure (NSDQ:NVCR) said today it won FDA premarket approval for its 2nd-generation Optune system designed to treat glioblastoma patients. The Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields” to inhibit cancer cell replication and cause cancer cell death. The next-generation device is smaller, lighter and […]

Filed Under: 510(k), Food & Drug Administration (FDA), Oncology, Regulatory/Compliance Tagged With: NovoCure

Skyline Medical CEO Kornberg steps down, Schwartz takes over as interim | Personnel Moves May 20, 2016

May 20, 2016 By Fink Densford

Skyline Medical CEO Kornberg steps down, Schwartz takes over as interim chief exec Skyline Medical said earlier this month that prez and CEO Joshua Kornberg has stepped away from his roles at the company, and is being replaced by Carl Schwartz who will serve as interim chief executive. Prior to his time at Skyline, Schwartz served […]

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Filed Under: Business/Financial News Tagged With: Battelle, EndoStim, LivaNova, Mauna Kea Technologies, Medtronic, NovoCure, Philips, Skyline Medical, Spirox, Volcano Corp.

A new frontier in the war on brain cancer with NovoCure chairman Bill Doyle

April 26, 2016 By Brian Johnson

Novocure, the St. Helier, Jersey-based medical device company, which raised more than $158M in an IPO last year, is trying to change the way we fight cancer. Company officials say its proprietary Tumor Treating Fields technology, marketed under the product name Optune, are a new tool in the war against cancer. Currently, the company has […]

Filed Under: Device Talks Podcasts Tagged With: NovoCure

FDA grants IDE to NovoCure for phase II Optune trial

April 25, 2016 By Fink Densford

NovoCure (NSDQ:NVCR) said today that Radiation Therapy Oncology Group Foundation won FDA investigational device exemption to conduct a Phase II pilot test of NovoCure’s Optune in conjunction with bevacizumab to treat bevacizumab-refractory recurrent glioblastoma. The Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields” to inhibit […]

Filed Under: Clinical Trials, Food & Drug Administration (FDA), Oncology Tagged With: NovoCure

Novocure wins reimbursement from Humana for Optune brain cancer device

March 3, 2016 By Fink Densford

NovoCure (NSDQ:NVCR) said today it won reimbursement from Humana for treatments with its Optune device for patients with recurrent glioblastoma. The Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields,” to inhibit cancer cell replication and cause cancer cell death. The new reimbursement win brings the […]

Filed Under: Business/Financial News, Oncology Tagged With: NovoCure

Brain cancer: NovoCure looks to get 2nd-gen Optune device on the U.S. market

January 6, 2016 By Brad Perriello

NovoCure (NSDQ:NVCR) said today that it applied for a supplemental pre-market approval from the FDA for the 2nd generation of its Optune device for treating glioblastoma, a form of brain cancer. The FDA approved Optune’s 1st iteration in April 2011. It’s a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields,” […]

Filed Under: Food & Drug Administration (FDA), Oncology, Radiosurgery/Radiation therapy, Regulatory/Compliance Tagged With: NovoCure

NovoCure touts JAMA publication of Optune trial data

December 15, 2015 By Fink Densford

NovoCure (NSDQ:NVCR) said today data from the pivotal phase 3 trial of its Optune device, in combination with standard-of-care temozolomide, for treating newly diagnosed glioblastoma has been published in the Journal of the American Medical Association. The results from the EF-14 trial reported that Optune along with temozolomide significantly extended progression-free survival and overall survival compared […]

Filed Under: Clinical Trials, Oncology Tagged With: NovoCure

Novocure touts preliminary data on tumor treating fields

December 4, 2015 By Fink Densford

NovoCure (NSDQ:NVCR) said yesterday that a retrospective analysis of its Tumor Treating Fields therapy showed it safe in adult glioblastoma patients with implanted non-programmable shunts. The FDA removed a pre-existing contraindication in October based on the safety data that contraindicated the therapy for patients with non-programmable shunts, Novocure said. The data was presented last month at […]

Filed Under: Clinical Trials, Oncology Tagged With: NovoCure

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