Monday, February 4, 2019
SI-Bone announces additional exclusive coverage policies for iFuse
SI-BONE announced the addition of several exclusive coverage policies for the iFuse Implant System. CareFirst BlueCross BlueShield, Premera Blue Cross Blue Shield and Excellus BlueCross BlueShield have published positive coverage policies for MIS SI joint fusion when performed exclusively with the triangular iFuse Implant System providing coverage for over 6.5 million lives. In total, there are 32 Blue Cross Blue Shield plans that now cover MIS SI joint fusion, 27 of which are exclusive to the triangular iFuse Implant System based on published clinical evidence. CareFirst is the largest health care insurer in the Mid-Atlantic region, covering 3.2 million members in Maryland, the District of Columbia and parts of Northern Virginia. CareFirst’s iFuse only policy took effect January 1, 2019. Premera Blue Cross is the largest health plan in the Pacific Northwest, covering over 2 million lives throughout Washington and Alaska. The Premera exclusive iFuse policy became effective February 1, 2019. Excellus BlueCross BlueShield policy took effect December 20, 2018 and provides access to the iFuse Procedure for almost 1.5 million customers in central and upstate New York.
https://thefly.com/landingPageNews.php?id=2858369
https://thefly.com/landingPageNews.php?id=2858369
Calithera Biosciences completes patient enrollment in Phase 2 Entrata trial
Calithera Biosciences announced that it has completed patient enrollment in the ongoing Phase 2 ENTRATA trial. ENTRATA is a randomized clinical study of the glutaminase inhibitor CB-839 combined with everolimus versus placebo with everolimus for the treatment of advanced renal cell carcinoma. CB-839 now has the International Nonproprietary Name telaglenastat, as recommended by the World Health Organization. The ENTRATA trial is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including a VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival. Calithera plans to report efficacy and safety data from the trial in the second half of 2019. Telaglenastat is also being investigated in the CANTATA trial, which will enroll approximately 400 patients and is designed with registrational intent. It is a global, randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced clear cell RCC who have been treated with one or two prior lines of systemic therapy. The primary endpoint is PFS by blinded independent review, and a key secondary endpoint is overall survival.
Optinose enters EDS license agreement with Inexia
Optinose announced that it has entered into a license agreement with Inexia whereby Inexia has obtained certain rights that will enable the use of Optinose’s exhalation delivery systems, or EDS, and other intellectual property in their effort to discover and develop novel therapies based on positive modulators of Orexin OX1 and OX2 for neurological diseases. Inexia was recently formed as part of a structured financing agreement between Japan-based Sosei Group and Medicxi. In exchange for this license, Optinose will receive an upfront payment and for each product developed under the license agreement is eligible to receive up to $8M of development milestone payments and up to $37M of sales milestone payments. In addition, Optinose is eligible for tiered, low-to-mid single digit royalties based on net sales of any products successfully developed and commercialized under the license agreement. Inexia will be responsible for all costs and activities related to the identification, development and commercialization of potential products under this license.
EyePoint announces commercial launch of Yutiq in U.S.
EyePoint announced it has commercially launched Yutiq in the United States. Yutiq is the company’s FDA approved, three-year micro-insert for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The product is available for ordering and delivery to physicians. The company has also launched EyePoint Assist, a program to ensure access to Yutiq for eligible patients in need of financial assistance.
eHealth initiated at Evercore ISI
eHealth initiated with an Outperform at Evercore ISI. Evercore ISI analyst Ross Muken initiated eHealth with an Outperform rating and $75 price target. In a research note to investors, Muken says that after a challenging period post-ACA, the company’s new management has successfully pivoted the strategy toward Medicare, positioning eHealth as a “unique ecommerce marketplace” and pricing transparency tools within healthcare. He sees eHealth as uniquely positioned to be a dominant player in the consumer centric healthcare revolution, and sees a path to $1B in revenue over the next decade.
Spero Therapeutics announces FDA acceptance of SPR994 IND application
Spero Therapeutics announced the acceptance by the FDA of its investigational new drug, or IND, application for SPR994, Spero’s lead product candidate designed to be the first oral carbapenem antibiotic, for the treatment of complicated urinary tract infections, or cUTI. This IND acceptance will enable Spero to initiate U.S. enrollment in its planned global, single pivotal Phase 3 clinical trial of SPR994 in cUTI. Spero’s planned pivotal Phase 3 clinical trial of SPR994, ADAPT-PO, is designed as a double-blind, double-dummy trial to compare oral SPR994 with an existing standard of care intravenous, or IV, antibiotic, ertapenem, in approximately 1,200 patients randomized 1:1 in each arm. The primary endpoint of the pivotal trial will be the combined clinical and microbiological response at the test of cure with a 10% non-inferiority margin versus IV ertapenem. The trial will incorporate a lead-in cohort of 70 patients with intensive pharmacokinetics assessment to confirm the dose and exposure in the cUTI patient population. Spero anticipates receiving interim pharmacokinetic data from the trial’s lead-in cohort in the second half of 2019. In addition, Spero will conduct routine ancillary clinical pharmacology studies in parallel with the ADAPT-PO clinical trial, including a renal insufficiency study, a thorough QT prolongation study and a drug-drug interaction study. Spero has begun start-up activities for the ADAPT-PO clinical trial and anticipates opening trial sites to support study enrollment in Q1.
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