Search Results for “FDA” – Page 182 – media

The Top 3 Digital Health Trends to Watch In 2018

Digital health broke out in 2017. We saw more investment than ever before: Over $4.7 billion flowed into a record number of companies. While these record-breaking investments underscore the enthusiasm for new digital health solutions, another revolution was quietly happening just outside the spotlight.
- Source: fortune
- 614
- December 21, 2017
digital health Researches Telemedicine
AbbVie Scores Key Trial Win for RA Drug With One Fatal Event Reported

AbbVie’s investigational JAK1-inhibitor upadacitinib yielded positive top-line results in a Phase III trial as a monotherapy for rheumatoid arthritis patients. But the drug shows that it is still plagued by some safety concerns.
- Source: Biospace
- 577
- December 21, 2017
Clinical Trials inhibitor Phase rheumatoid arthritis
Ultragenyx Sells Priority Review Voucher for $130 million

“The sale of the PRV provides us with an important source of non-dilutive capital to help advance our pipeline of rare and ultra-rare therapies, and accelerates the availability of these potential therapies to patients,” said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx.
- Source: finance.yahoo
- 716
- December 20, 2017
FDA Market Views Novartis PRV
Surgical Device Company Virtual Incision Raises $18 Million in Series B

Virtual Incision’s RASD weighs just two pounds and is designed to perform the procedure through a smaller incision, potentially reducing recovery time and mitigating the risk of surgical complications.
- Source: xtalks
- 568
- December 18, 2017
FDA medical device RASD Series
Chi-Med Initiates Fruquintinib U.S. Clinical Trials

Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers. The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.
- Source: chi-med
- 669
- December 18, 2017
cancer Clinical Trials Fruquintinib
Ionis Pharmaceuticals Licenses IONIS-HTT Rx to Partner Following Successful Phase 1/2a Study in Patients with Huntington’s Disease

Ionis Pharmaceuticals, Inc. (IONS) announced today that Roche has exercised its option to license IONIS-HTTRx following the completion of a Phase 1/2a randomized, placebo-controlled, dose escalation study of IONIS-HTTRx in people with Huntington's disease (HD). Roche will now be responsible for all development and commercial activities. IONIS-HTTRx is the first therapy in clinical development designed to target the underlying cause of HD by reducing the production of the toxic mutant huntingtin protein (mHTT). In conjunction with the decision to license IONIS-HTTRx, Ionis earned a $45 million license fee from Roche.
- Source: finance.yahoo
- 485
- December 15, 2017
Clinical Trials Huntington’s Disease IONIS-HTTRx
Bayer receives approval in China for Stivarga® (regorafenib) for the second-line systemic Treatment of liver cancer

Approval based on data from the Phase III RESORCE study where Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib)
- Source: investor.bayer
- 701
- December 14, 2017
Bayer CFDA hepatocellular carcinoma Nexavar® Stivarga®
Gottlieb Announces More Regulatory Updates to Encourage Device Innovation

Less than a week after announcing 3 new guidance documents to streamline the review of digital health, the FDA is moving to refine its 510(k) medical device approval pathway.
- Source: hcanews
- 516
- December 12, 2017
digital health medical device Policy
Philippines halts sale of Sanofi’s dengue vaccine

The Philippines has suspended the sale and distribution of Sanofi’s dengue vaccine, authorities said on Tuesday, after the French pharmaceutical giant last week warned it could worsen symptoms for people who had not previously been infected.
- Source: Thenews
- 759
- December 12, 2017
Dengvaxia vaccine Sanofi’s dengue vaccine
Sage Therapeutics Erupts as Depression Drug Wows in Mid-Stage Study

Shares of Sage Therapeutics have shot up more than 75 percent this morning after the company announced positive topline results for its Phase II treatment for patients with moderate to severe major depressive disorder (MDD).
- Source: Biospace
- 506
- December 11, 2017
Clinical Trials MDD SAGE-217

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