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Clinical Trial Program Articles & Analysis

317 news found

CanaQuest Announces Key Appointments to Team to Drive CQ-001 through Clinical Trials

CanaQuest Announces Key Appointments to Team to Drive CQ-001 through Clinical Trials

CanaQuest Medical Corp (“CanaQuest” or the “Company”) (OTC: CANQF), is pleased to announce strategic additions to its executive team with expertise in conducting clinical trials and US FDA drug approval success. The team plans to effectively navigate the regulatory approval process for Drug Candidate, CQ-001 (cannabidiol + proprietary API composition), to treat rare ...

ByCanaQuest Medical Corp.


Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

The OCEANIC-AF (atrial fibrillation) study with asundexian is part of the Phase III OCEANIC clinical trial program enrolling more than 27,000 patients in over 40 countries Asundexian is being evaluated as a potential improved treatment option in stroke prevention and could be part of an entirely new class of treatment options in thrombosis ...

ByBayer AG


Tris Pharma Expands Leadership Team as Company Broadens Commercial Portfolio and Progresses Clinical Pipeline

Tris Pharma Expands Leadership Team as Company Broadens Commercial Portfolio and Progresses Clinical Pipeline

Thomas Englese, a 20+ year industry veteran with a track record of success at leading biopharmaceutical companies, joins as chief commercial officer Marc Lesnick, Ph.D., appointed as chief development officer, bringing more than 20 years of experience in multiple therapeutic areas Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on ADHD, pain and neurological ...

ByTris Pharma, Inc.


New data from pivotal studies with aflibercept 8 mg

New data from pivotal studies with aflibercept 8 mg

The following new abstracts for aflibercept 8 mg will be presented at ARVO 2023: The pooled safety analysis compares the safety of aflibercept 8 mg with aflibercept 2 mg across the clinical trial program which includes data from the phase II trial CANDELA in nAMD and the pivotal phase II/III trial PHOTON in DME ...

ByBayer AG


Bayer expands global clinical program for darolutamide in prostate cancer

Bayer expands global clinical program for darolutamide in prostate cancer

Phase III study ARASTEP initiated in hormone-sensitive prostate cancer, in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET CT at baseline Fifth major clinical trial for androgen receptor inhibitor (ARi) darolutamide, covering prostate cancer from early to ...

ByBayer AG


Circulating Tumor Cell detection by Menarini Group’s CELLSEARCH System leading to genomic profiling of myeloma cells shows potential for non-invasive management of Multiple Myeloma patients at early stages of disease

Circulating Tumor Cell detection by Menarini Group’s CELLSEARCH System leading to genomic profiling of myeloma cells shows potential for non-invasive management of Multiple Myeloma patients at early stages of disease

Researchers at Dana-Farber Cancer Institute showed that enumeration of circulating tumor cells (CTCs) with Menarini Silicon Biosystems’ CELLSEARCH® System and the CELLSERCH® Circulating Multiple Myeloma Cell (CMMC) Test* can be used to monitor and manage patients with Multiple Myeloma (MM) even at asymptomatic precursor stages Menarini Silicon Biosystems, a pioneer of liquid biopsy ...

ByThe Menarini Group


ViGeneron presents preclinical data on intravitreal gene therapy of Stargardt disease at ESGCT

ViGeneron presents preclinical data on intravitreal gene therapy of Stargardt disease at ESGCT

Efficient transfer of larger gene via ViGeneron’s proprietary technology platforms REVeRT and vgAAV ViGeneron advances its preclinical programs for Stargardt disease and Retinitis Pigmentosa into IND-enabling activities and clinical stage development ViGeneron GmbH, a next-generation gene therapy company, today announced the presentation of preclinical data on its program VG801 in ...

ByViGeneron GmbH


ViGeneron Announces Closing of Series A Financing to Drive Development of Next Generation Gene Therapy Pipeline

ViGeneron Announces Closing of Series A Financing to Drive Development of Next Generation Gene Therapy Pipeline

ViGeneron GmbH, a gene therapy company, announced the closing of its series A financing round led by WuXi AppTec and Sequoia Capital China. The proceeds will enable ViGeneron to accelerate its proprietary viral vector-based gene therapy platforms and drive product development in its two lead ophthalmic gene therapy programs. Funds will advance development of ViGeneron’s next-generation ...

ByViGeneron GmbH


Beyond Cancer Announces Sponsored Research Agreement with Stanford and Appointment of Frederick M. Dirbas, MD and Mark D. Pegram, MD to Scientific Advisory Board

Beyond Cancer Announces Sponsored Research Agreement with Stanford and Appointment of Frederick M. Dirbas, MD and Mark D. Pegram, MD to Scientific Advisory Board

The Company expects the protocols for its clinical program to be influenced by the preclinical data and the Phase 1 clinical trial experience. ...

ByBeyond Air Inc


Oligomerix Presents Data on Lead Program at Clinical Trials on Alzheimer’s Disease (CTAD) Conference and Society for Neuroscience Meeting

Oligomerix Presents Data on Lead Program at Clinical Trials on Alzheimer’s Disease (CTAD) Conference and Society for Neuroscience Meeting

Oligomerix, Inc., a privately held company pioneering the development of small molecule therapeutics targeting tau for Alzheimer’s and rare neurodegenerative diseases, announced that the Company presented data from a therapeutic study in an animal model of its lead product candidate OLX-07010 at the 14th Annual Clinical Trials on Alzheimer's Disease (CTAD) ...

ByOligomerix, Inc.


Oligomerix Announces Series B Extension Raise of $2.7 Million to Support Phase 1 Clinical Development

Oligomerix Announces Series B Extension Raise of $2.7 Million to Support Phase 1 Clinical Development

“We have demonstrated preclinical safety and efficacy of our oral, small molecule program through well designed pre-clinical studies, and are now poised to take a major step into clinical development. ...

ByOligomerix, Inc.


MorphoSys AG: MorphoSys Expects Topline Data from Phase 3 Study of Pelabresib in Myelofibrosis in Early 2024

MorphoSys AG: MorphoSys Expects Topline Data from Phase 3 Study of Pelabresib in Myelofibrosis in Early 2024

MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that topline data from the ongoing Phase 3 MANIFEST-2 study – a global, randomized, double-blind clinical trial exploring pelabresib, an investigational BET inhibitor, in combination with ruxolitinib as a first-line treatment for patients with myelofibrosis – are expected to be available in early ...

ByMorphoSys AG


Proteros receives minority investment from private equity firm Inflexion

Proteros receives minority investment from private equity firm Inflexion

Proteros biostructures GmbH, a leading German-based, founder-led contract research organization focused on early-stage drug discovery today announced that it has received a minority investment from Inflexion, a leading middle-market private equity firm investing in high-growth, entrepreneurial businesses, by way of partnership capital funding. The transaction is subject to customary regulatory ...

ByProteros Biostructures GmbH


AskBio Announces Strategic Collaboration with ReCode Therapeutics to Explore Single Vector Gene Editing Platform

AskBio Announces Strategic Collaboration with ReCode Therapeutics to Explore Single Vector Gene Editing Platform

Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, announced today that it has signed a multi-year research collaboration and option agreement with ReCode Therapeutics. Under this agreement, the companies will work together to potentially discover precision genetic medicines through the development of a novel platform for full gene ...

ByBayer AG


Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD

Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD

To request a meeting, please contact Cingulate Investor Relations at mkreps@darrowir.com. The Phase 3 clinical trial is an adult dose-optimization study to assess the onset and duration of efficacy along with the safety of CTx-1301 in adults with ADHD compared to placebo. ...

ByCingulate


Iterative Health Partners with Gastro Health to Accelerate Clinical Research in Gastroenterology Through Artificial Intelligence

Iterative Health Partners with Gastro Health to Accelerate Clinical Research in Gastroenterology Through Artificial Intelligence

This strategic partnership will lay the groundwork for future collaborations by using AIR to aid in the recruitment of patients for clinical trials in inflammatory bowel disease (IBD) and expanding Gastro Health’s clinical research capabilities. ...

ByIterative Health, Inc.


MorphoSys Out Licenses Pre-Clinical Oncology Program

MorphoSys Out Licenses Pre-Clinical Oncology Program

Novartis obtains exclusive worldwide rights for pre-clinical inhibitors of a novel cancer target MorphoSys receives an upfront payment of $23 million, potential milestone payments, plus mid-single- to low-double-digit royalties on net sales MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its fully owned subsidiary Constellation Pharmaceuticals, Inc. has entered into a global ...

ByMorphoSys AG


Sage Therapeutics and Biogen Present Further Analyses from Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression at the European College of Neuropsychopharmacology (ECNP) Congress

Sage Therapeutics and Biogen Present Further Analyses from Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression at the European College of Neuropsychopharmacology (ECNP) Congress

Zuranolone 50 mg demonstrated a clinically meaningful and statistically significant improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpoints as previously reported Newly presented data offered additional insight into the SKYLARK Study and further demonstrated the rapid improvements in depressive symptoms observed in ...

BySage Therapeutics


InMed Pharmaceuticals Announces Closing of $6 Million Private Placement Priced at a Premium to Market

InMed Pharmaceuticals Announces Closing of $6 Million Private Placement Priced at a Premium to Market

VANCOUVER, British Columbia, Nov. 21, 2022 (GLOBE NEWSWIRE) -- InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, today announced the closing of its previously announced private placement with two healthcare-focused institutional investors ...

ByInMed Pharmaceuticals Inc.


InMed Pharmaceuticals Announces $6 Million Private Placement Priced at a Premium to Market

InMed Pharmaceuticals Announces $6 Million Private Placement Priced at a Premium to Market

VANCOUVER, British Columbia, Nov. 18, 2022 (GLOBE NEWSWIRE) -- InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development and manufacturing of rare cannabinoids and cannabinoid analogs, today announced that it has entered into a securities purchase agreement with two healthcare-focused institutional investors ...

ByInMed Pharmaceuticals Inc.

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