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News Breaks
February 19, 2013
07:08 EDTGSK, ISISIsis Pharmaceuticals initiates Phase 2/3 study of ISIS-TTR Rx
Isis Pharmaceuticals (ISIS) has earned a $7.5M milestone payment from GlaxoSmithKline (GSK) related to the initiation of a Phase 2/3 clinical study for ISIS-TTRRx. ISIS-TTRRx is an antisense drug in development with GlaxoSmithKline for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Isis and GSK recently amended the clinical development plan and financial terms relating to ISIS-TTRRx to support this registration-directed Phase 2/3 clinical study on ISIS-TTRRx. The Phase 2/3 study of ISIS-TTRRx is a randomized, double-blinded, placebo-controlled, international study designed to support an application for marketing approval of ISIS-TTRRx in patients with FAP. The fifteen month study will enroll approximately 200 patients randomized 2:1 to receive 300 mg/week of ISIS-TTRRx or placebo and will measure the effects of ISIS-TTRRx on neurological dysfunction and on quality-of-life. The United States Food and Drug administration granted ISIS-TTRRx fast track designation and orphan drug status for the treatment of FAP.
News For ISIS;GSK From The Last 14 Days
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August 4, 2015
09:03 EDTISISIsis Pharmaceuticals reports Q2 EPS 29c, consensus 29c
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07:53 EDTGSKEndocyte names Alison Armour chief medical officer
Endocyte (ECYT) announced that Alison A. Armour has been appointed as chief medical officer. Prior to joining Endocyte, Dr. Armour served as vice president of oncology at Novartis (NVS) and GSK (GSK).
August 3, 2015
17:06 EDTISISIsis reports FOCUS FH Phase 3 study met primary efficacy endpoint
Isis Pharmaceuticals (ISIS) announced that the FOCUS FH phase 3 study of KYNAMRO in patients with severe heterozygous familial hypercholesterolemia met its primary efficacy endpoint, a statistically significant reduction in LDL-cholesterol after 60 weeks of treatment of once weekly injections of 200 mg of KYNAMRO compared to placebo. LDL-cholesterol reduction was similar to that observed in previous phase 3 studies. In addition, based on the data available for review, the safety profile of KYNAMRO observed in the FOCUS FH trial was similar to the safety profile reported in previous phase 3 studies. Genzyme (SNY) will provide a more in depth review of the safety and efficacy data at a future medical meeting.
05:39 EDTISISIsis Pharmaceuticals and AstraZeneca collaborate to develop antisense drugs
Isis Pharmaceuticals (ISIS) and AstraZeneca (AZN) announced a strategic collaboration to discover and develop antisense therapies for cardiovascular, metabolic and renal diseases. The new collaboration builds on a broad existing relationship between the two companies and supports AstraZeneca's strategic approach in these therapeutic areas using novel RNA-targeted treatments. It also enables Isis Pharmaceuticals to extend use of its antisense technology to diseases of the kidney. AstraZeneca will pay an upfront fee of $65M to Isis Pharmaceuticals plus development and regulatory milestones for each program that AstraZeneca advances to clinical development. Isis Pharmaceuticals is also eligible to earn tiered double-digit royalties on annual net sales for each program. This transaction is subject to clearances under the Hart-Scott Rodino Antitrust Improvements Act.
July 31, 2015
17:31 EDTISISIsis Pharmaceuticals cuts stake in Regulus to 5.57%
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July 29, 2015
17:13 EDTISISIsis announces publication of Phase 2 clinical results from volanesorsen study
Isis Pharmaceuticals and Akcea Therapeutics, its wholly owned subsidiary, announced that the New England Journal of Medicine has published positive clinical results from a Phase 2 clinical study evaluating volanesorsen, formerly ISIS-APOCIIIRx, in patients with very high to severely high triglycerides. This publication follows the December 2014 publication in the New England Journal of Medicine of the positive Phase 2 results from a clinical study of volanesorsen in patients with familial chylomicronemia syndrome. Volanesorsen is part of Isis' lipid franchise, which is being developed and commercialized by Akcea Therapeutics.
14:49 EDTGSKGlaxoSmithKline probing new bribery allegations in Romania, Reuters reports
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08:00 EDTGSKGlaxoSmithKline reports Q2 global pharmaceuticals revenue GBP2.98B, down 12%
Reports Q2 HIV revenue GBP559M, up 59%. Reports Q2 Pharmaceuticals revenue GBP3.54B, down 6%, and vaccines revenue GBP814M, up 11%. Consumer healthcare sales were GBP1.51B, up 51% year over year.
07:58 EDTGSKGlaxoSmithKline sees FY16 core EPS to grow in double digits
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07:57 EDTGSKGlaxoSmithKline reaffirms FY15 core EPS declining at high-teens percentage rate
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07:54 EDTGSKGlaxoSmithKline reports Q2 adjusted EPS 17.3p, consensus 16.78p
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July 27, 2015
17:31 EDTGSKRadius Health hires Dr. Lorraine Fitzpatrick as Chief Medical Officer
Radius Health (RDUS) announced that it has hired Dr. Lorraine A. Fitzpatrick as Chief Medical Officer of the Company. Dr. Fitzpatrick was previously Medicine Development Leader of an international clinical development team for Denosumab at GlaxoSmithKline (GSK), responsible for clinical development, regulatory, manufacturing, commercial, operations, epidemiology, and global health outcomes. Previously, Dr. Fitzpatrick led the clinical development of novel agents to treat musculoskeletal diseases and women's health at GlaxoSmithKline. Before joining GlaxoSmithKline, Dr. Fitzpatrick was Executive Director at Amgen, Inc. where she worked in the fields of osteoporosis and oncology.
10:40 EDTISISIsis 'most obvious' Biogen takeover target, TheStreet's Feuerstein says
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08:03 EDTGSKNephroGenex names Jaikrishna Patel as Chief Medical Officer
NephroGenex (NRX) announced the appointment of Dr. Jaikrishna Patel to the position of Chief Medical Officer. Dr. Patel will help guide the company’s Phase 3 PIONEER program with oral Pyridorin for the treatment of diabetic nephropathy, and the development of an intravenous formulation of Pyridorin for acute kidney injury. Patel has held numerous positions of increasing responsibility at GlaxoSmithKline (GSK) and its predecessor companies, most recently serving as Vice President of Cardiovascular and Cardiovascular Metabolism, Global Regulatory Affairs.
07:07 EDTISISIsis Pharmaceuticals announces results from ISIS-TTRRx study
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July 24, 2015
05:04 EDTGSKAgenus reports GSK Malaria vaccine receives positive opinion from CHMP of EMA
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July 22, 2015
19:26 EDTISISIsis Pharmaceuticals announces positive clinical data of ISIS-APO(a)Rx published
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July 21, 2015
07:13 EDTISISIsis Pharmaceuticals initiates Phase 1/2a clinical study of ISIS-HTT Rx
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