AtriCure announced the first patient was treated in the ICE-AFIB trial. Following Investigational Device Exemption approval by the FDA, the first patient was treated by Dr. Niv Ad, at Washington Adventist Hospital in Takoma Park, Maryland. The trial will evaluate the safety and effectiveness of the cryoICE Ablation System for the treatment of persistent and long-standing persistent atrial fibrillation during concomitant open-chest cardiac surgery.
Tuesday, February 5, 2019
Pharm-Olam enrolls patients in Zealand Pharma orphan drug study
Pharm-Olam is now enrolling patients in the U.S. and Europe into a pivotal Phase III study within the treatment of short bowel syndrome. Initiated in early October 2018, the study is a placebo-controlled, randomized, parallel-group, double-blind clinical trial with fixed-dose injections. The trial is being conducted at approximately 40 investigational sites in the United States, Canada, and Europe and will ultimately enroll 129 patients with SBS. Because people with SBS often cannot absorb enough nutrients, the trial will help determine if parenteral support volume can be reduced. Zealand Pharma is developing a long-acting GLP-2 analog in an auto-injector with potential for convenient weekly administration, which has been granted orphan status by the U.S. Food and Drug Administration.
Inspire Medical reports positive coverage policies from 5 BCBSA plans
Inspire Medical Systems announced an additional five Blue Cross Blue Shield Association healthcare plans have issued positive coverage policies of Inspire therapy. These plans include Blue Cross Blue Shield of Mississippi, BCBS Regence, Premera Blue Cross, BCBS of Kansas, and BCBS of Massachusetts, which provide coverage for an aggregate of 8.4 million members. BCBS of Mississippi covers approximately 590,000 members and took effect January 1, 2019. Regence covers approximately 2.6 million members across Washington, Oregon, Idaho and Utah and took effect February 1,2019. Premera is the largest health plan in the Pacific Northwest covering over 2.1 million members in Washington and Alaska and took effect February 1, 2019. BCBS of Kansas covers approximately 560,000 members and took effect February 1, 2019. BCBS of Massachusetts covers approximately 2.6 million members and will take effect May 1, 2019. There have now been eight positive coverage policies issued by BCBSA healthcare plans following BCBSA Evidence Street’s January 7, 2019 report, which stated that there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria. These eight Inspire therapy coverage policies comprise approximately 16.6 million members, or 17%, of the total 97 million members currently covered under the BCBSA healthcare plans.
AstraZeneca initiated at Exane BNP Paribas
AstraZeneca initiated with an Outperform at Exane BNP Paribas
Moderna doses first subject in Phase 1 clinial trial of mRNA-1944
Moderna announced the dosing of the first subject in a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of mRNA-1944 via intravenous infusion in healthy adults. This is the first monoclonal antibody encoded by mRNA to be dosed in a human and the first development candidate from the Company’s systemic therapeutics modalities to start clinical testing. mRNA-1944 encodes a fully human IgG antibody originally isolated from B cells of a patient with a prior history of potent immunity against Chikungunya infection. It is composed of two mRNAs that encode the heavy and light chains of this anti-Chikungunya antibody within Moderna’s proprietary lipid nanoparticle technology. Preclinical studies of mRNA-1944 showed linear dose-dependence, meaning increases in the dose of mRNA led to nearly proportionate increases in antibody production. The research and development of mRNA-1944 was financially supported by the Defense Advanced Research Projects Agency, an agency of the U.S. Department of Defense.
Benchmark downgrades Amedisys to Hold after rally, awaits better entry point
Benchmark analyst Bill Sutherland downgraded Amedisys to Hold from Buy, noting that the stock has risen 36% since the company announced its now-closed deal to acquire Compassionate Care Hospice and a strong Q3 earnings report. Amedisys now sells at “a wide premium” to other home health/hospice names and Sutherland recommends investors await a better entry point, as he also thinks there is modest integration risk for Compassionate.
Piper Jaffray reiterates Overweight rating on Xencor after Genentech deal
Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating and $52 price target on Xencor, after the company partnered with Genentech to develop IL-15 targeted cytokine therapies, including XmAb24306. The analyst noted that Xencor will receive $120M upfront, and that the company is also eligible for $160M in XmAb24306-related milestones and $180M in milestones for each new IL-15 candidate. Tenthoff also noted that Xencor will have the right to co-promote in the U.S. and is eligible to receive 45% share of net profits sales.
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