國際新聞精選周六（2017年4月8日）

2017年4月8日 | Filed under: | Posted by: 編輯 D

Chi-Med Presented Pre-clinical Data for Fruquintinib and Sulfatinib at the American Association for Cancer Research Annual Meeting 2017

Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq:HCM) presented pre-clinical data for fruquintinib and sulfatinib at the American Association for Cancer Research (“AACR”) Annual Meeting 2017, held in Washington, D.C., USA from April 1 to 5, 2017. Fruquintinib and sulfatinib are both being evaluated in Phase III clinical trials for various cancers.【閱讀原文】

Medivir posts lymphoma data, guns to get into phase 3

Medivir has posted data from a phase 2 trial of its histone deacetylase (HDAC) inhibitor in patients with cutaneous T-cell lymphoma (CTCL). One regimen of the treatment triggered responses in 40% of subjects, a finding that has encouraged the Swedish pharmaceutical company to push ahead with plans to start a phase 3 trial later this year.【閱讀原文】

Kura Oncology Doses First Patient in Phase 1 Trial of ERK Inhibitor KO-947

y, today announced that the first patient has been dosed in its Phase 1 clinical trial of KO-947, a potent and selective small molecule inhibitor of extracellular-signal-regulated kinases 1 and 2 (ERK1/2).【閱讀原文】

Biomarin’s rare disease approval and Probiodrug’s Alzheimer’s play

Welcome to your weekly digest of approaching regulatory and clinical readouts. Biomarin is looking for approval of its enzyme-replacement therapy Brineura in a rare condition called CLN2 disease, which leads to developmental deterioration in children. The US regulators will decide by April 27, but could announce an advisory meeting in the coming weeks.【閱讀原文】

FDA allows 23andMe to sell DTC genetic tests for 10 conditions

It’s been a long road for 23andMe, but not without reward. The FDA authorized the marketing of the company’s genetic health risk tests, the first tests OK’d by the agency that provide this information directly to consumers.【閱讀原文】

PET imaging measures PARP-1 in ovarian cancer patients

University of Pennsylvania scientists have devised a new imaging test to measure the amount of PARP-1 enzyme in ovarian cancer patients, which could help identify which patients would benefit most from treatments that target PARP-1.【閱讀原文】

Blood vessels built from skin cells help repair damaged hearts in mice

One of the primary goals of regenerative medicine is to find new ways of fighting heart disease, the leading cause of death around the world. Coaxing stem cells to become heart cells is one popular technique, but scientists at the University of Illinois at Chicago believe they might have found an even better way to repair damaged hearts—by transforming skin cells into blood vessels.
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Merck's Diabetes Franchise And The Perils In Proving A Drug's Medical Value

Merck’s Januvia (sitagliptin) and its metformin combination, Janumet, are important drugs for type 2 diabetes patients as well as for Merck’s bottom line. These drugs, which are DPP-4 inhibitors, account for more than $6 billion in sales for this drug giant. Given the growing incidence of obesity and type 2 diabetes in the world, this franchise is poised for continued growth.【閱讀原文】

Ocrelizumab- FDA Approved Treatment of MS

Ocrelizumab (OCREVUS?), an anti-B cell therapy has been approved by the FDA as of March 28th 2017, for the treatment of Relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). This treatment is highly effective for RRMS, based on the data from the Phase III clinical studies. It is also the first drug approved for use in PPMS. At IMSMP/TISCH we have used Rituximab, a similar anti-B cell treatment, for the past 16 years with great success. It is because of the effectiveness of this therapy (Rituximab) we were able to persuade Medicare to cover the costs of this therapy in New York.【閱讀原文】

Merck's Diabetes Franchise And The Perils In Proving A Drug's Medical Value

Merck Receives Complete Response Letter from the U.S. FDA for TECOS Study with Sitagliptin

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck’s Supplemental New Drug Applications for JANUVIA? (sitagliptin), JANUMET? (sitagliptin and metformin HCl) and JANUMET XR? (sitagliptin and metformin HCl extended-release). With these applications, Merck is seeking to include data from TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) in the prescribing information of sitagliptin-containing medicines. Merck is reviewing the letter and will discuss next steps with the FDA. 【閱讀原文】

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