Clinical Trials – Page 6

Eisai and Purdue Pharma Announce Positive Topline Results From Key Clinical Studies of Lemborexant Including First-Ever Phase 3 Head-to-Head Superiority Comparison Versus Zolpidem ER in Patients With Sleep Disorder

Eisai Co., Ltd. (CEO: Haruo Naito, "Eisai") and Purdue Pharma L.P. (President and CEO: Craig Landau, "Purdue Pharma") today announced positive topline results from multiple studies of lemborexant, an investigational agent for sleep and wake regulation currently being studied for the treatment of multiple sleep disorders.

Source: finance.yahoo.
538
March 9, 2018

Global Investors Back Rani Therapeutics With $53 Million As Company Moves To Clinical Trials

Rani Therapeutics, the developer of a pill designed to replace injectable drug delivery for patients suffering from chronic diseases, today announced that it has raised $53 million to invest in manufacturing in preparation for human clinical trials. This investment brings the total raised to $142 million in funding.

Source: Prnewswire;
526
February 13, 2018

chronic diseases Clinical Trials Series

TriNetX buffs Sanofi’s digital trials and other digital health deals

Sanofi has found yet another partner to help digitize its clinical trial processes. In a statement, TriNetX announced that it will be assisting the pharmaceutical company by using patient EHRs to optimize recruitment, streamline trial investigators’ workflows, and otherwise impact the design of investigational drug trials. Sanofi has made similar arrangements to bolster its clinical trials with Science 37 and Evidation in March and July of last year, respectively.

Source: MobiHealthNews
710
January 30, 2018

Clinical Trials Company Insight EHR Sanofi

AstraZeneca’s Three-in-One COPD Inhaler Succeeds in Phase III Trial

AstraZeneca has GlaxoSmithKline and its chronic obstructive pulmonary disease (COPD) treatment Trelegy Ellipta squarely in its sights. This morning, AstraZeneca revealed Phase III data that shows its experimental three-in-one inhaler PT010 improved lung function in patients.

Source: Biospace
593
January 29, 2018

Clinical Trials COPD inhaler

Amgen Jumps as Migraine Drug Wows in Late-Stage Study

Amgen’s migraine drug Aimovig continues to impress with its efficacy in late-stage studies. On Monday, the company revealed Phase IIIb data that demonstrated the drug is also effective in reducing the number of episodic headaches in patients who have not responded to previous treatments.

Source: biospace
623
January 25, 2018

Aimovig Amgen Clinical Trials episodic headaches migraine

Alzheimer’s Drug Turns Back Clock in Powerhouse of Cell

The experimental drug J147 is something of a modern elixir of life; it’s been shown to treat Alzheimer’s disease and reverse aging in mice and is almost ready for clinical trials in humans.

Source: Neuroscience News
603
January 12, 2018

Alzheimer's disease Clinical Trials Researches

Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

The China Food and Drug Administration (CFDA) has announced new and updated regulations for medical device registration, testing and clinical trial requirements in the early days of 2018.

Source: Emergo
831
January 10, 2018

CFDA Clinical Trials medical device polices

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
592
December 21, 2017

Clinical Trials inhibitor Phase rheumatoid arthritis

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
688
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
492
December 15, 2017

Clinical Trials Huntington’s Disease IONIS-HTTRx

Eisai and Purdue Pharma Announce Positive Topline Results From Key Clinical Studies of Lemborexant Including First-Ever Phase 3 Head-to-Head Superiority Comparison Versus Zolpidem ER in Patients With Sleep Disorder

Global Investors Back Rani Therapeutics With $53 Million As Company Moves To Clinical Trials

TriNetX buffs Sanofi’s digital trials and other digital health deals

AstraZeneca’s Three-in-One COPD Inhaler Succeeds in Phase III Trial

Amgen Jumps as Migraine Drug Wows in Late-Stage Study

Alzheimer’s Drug Turns Back Clock in Powerhouse of Cell

Latest Chinese Medical Device Regulatory Changes Affect Clinical Trials, Testing, Telehealth

AbbVie Scores Key Trial Win for RA Drug With One Fatal Event Reported

Chi-Med Initiates Fruquintinib U.S. Clinical Trials

Ionis Pharmaceuticals Licenses IONIS-HTT Rx to Partner Following Successful Phase 1/2a Study in Patients with Huntington’s Disease

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