Search Results for “Clinical Trial” – Page 31 – media

Leading CROs, Veeva team up for open tech on trials

Six big contract research companies, alongside Veeva Systems, are for the first time coming together to develop open technology standards aimed at “transforming clinical trial ops” to speed up development.
- Source: fiercebiotech
- 577
- March 30, 2018
Clinical Trial CRO
Alnylam Presents New Clinical Results from the APOLLO Phase 3 Study of Patisiran at the 16th International Symposium on Amyloidosis

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced that the Company presented new results from the APOLLO Phase 3 study of patisiran, an investigational, RNAi therapeutic for the treatment of hereditary ATTR (hATTR) amyloidosis at the 16th International Symposium on Amyloidosis (ISA), being held March 26-29, 2018 in Kumamoto, Japan. In addition, the Company presented new data from the Phase 1 study of ALN-TTRsc02, an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis.
- Source: biospace
- 579
- March 30, 2018
ATTR amyloidosis Clinical Trials hereditary ATTR
Astellas and Seattle Genetics Announce Updated Enfortumab Vedotin Phase 1 Data in Metastatic Urothelial Cancer at 2017 ASCO Annual Meeting -Pivotal Monotherapy Phase 2 Trial Initiation Planned for 2017-

Astellas and Seattle Genetics, Inc. (NASDAQ: SGEN) highlighted updated phase 1 data for enfortumab vedotin (ASG-22ME) studied as monotherapy treatment for metastatic urothelial cancer (mUC) in an oral presentation at the American Society of Clinical Oncology (ASCO) 52nd Annual Meeting in Chicago. Enfortumab vedotin is an investigational antibody-drug conjugate (ADC) that targets Nectin-4, a cell surface protein expressed in multiple solid tumors including mUC, ovarian cancer, and non-small cell lung cancer (NSCLC). Based on the data from the ongoing phase 1 clinical trial, the companies this year plan to initiate a registrational monotherapy phase 2 trial for locally advanced or mUC patients who have been previously treated with checkpoint inhibitor (CPI) therapy. A trial evaluating enfortumab vedotin in combination with CPIs is also planned for later this year as part of a broad clinical development program.
- Source: newsroom.astellas.us
- 541
- March 28, 2018
Astellas monotherapy mUC Seattle Genetics
Denali Therapeutics Announces First-In-Human Dosing Of Its RIPK1 Inhibitor Clinical Program And The Appointment Of Peter Klein To Board Of Directors;

Denali Therapeutics Inc. (NASDAQ:DNLI), a biopharmaceutical company developing a broad portfolio of therapeutic candidates for neurodegenerative diseases, today announced that it has commenced dosing of its small molecule inhibitor of RIPK1 in a Phase 1 clinical trial in healthy volunteers and achieved proof of concept of its large molecule blood-brain barrier delivery platform technology in nonhuman primates.
- Source: Nasdaq
- 551
- March 21, 2018
Clinical Trial neurodegenerative disease RIPK1
New Late-Breaking Study Finds Wearable Electrocardiogram (ECG) Monitoring Patch Can Detect Atrial Fibrillation Earlier and More Efficiently than Routine Care

Janssen leads in cardiovascular innovation using real-world data to detect asymptomatic atrial fibrillation Home-based clinical study underscores the game-changing role of digital technology in future of health care
- Source: jnj
- 789
- March 14, 2018
AFib ECG Janssen Johnson & Johnson
Final FDA Rule Requires Medical Device Trials Outside US to Conform to GCP

The US Food and Drug Administration (FDA) on Tuesday finalized a rule that requires medical device clinical investigations conducted outside the US to flexibly conform with good clinical practice (GCP) standards.
- Source: Regulatory Affairs Professionals Society
- 633
- February 24, 2018
FDA medical device Policies
ViiV kicks off PhIII trial of two-drug HIV regimen

ViiV Healthcare, an HIV specialist firm majority owned by GlaxoSmithKline, has announced the launch of a late-stage study investigating the effectiveness of a two-drug regimen programme in patients with HIV.
- Source: pharmatimes
- 559
- February 12, 2018
Clinical Trial HIV Phase TANGO
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
- 696
- January 30, 2018
Clinical Trials Company Insight EHR Sanofi
Aspyrian Therapeutics Inc. announces successful advances in RM-1929 clinical development

Aspyrian Therapeutics Inc. announces successful advances in RM-1929 clinical development in recurrent Head and Neck Cancer, including Fast Track designation granted by the FDA, initiation of clinical studies in Japan, and plans to start pivotal studies, which will incorporate the evaluation of anti-cancer immune responses, in early 2018.
- Source: Prnewswire
- 740
- January 19, 2018
anti-cancer immune New Approvals RM-1929
Novartis advances head-to-head superiority trials of Cosentyx® versus Humira®* and proposed biosimilar adalimumab**

Novartis announced the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondylitis (AS). SURPASS is the first head-to-head clinical trial in AS investigating superiority of Cosentyx in slowing spinal bone damage versus proposed biosimilar adalimumab**. SURPASS is currently recruiting patients, with the 'first patient first visit' already achieved in November 2017.
- Source: drugdu
- 718
- January 11, 2018
adalimumab** Company Insight Cosentyx® Novartis Researches

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