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Mallinckrodt Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of StrataGraft® Regenerative Tissue in Patients with Deep Partial-thickness Thermal Burns
- Study met both co-primary endpoints with high statistical significance, demonstrating autograft sparing and durable wound closure at three months with StrataGraft - - Company plans to submit Biologics License Application to the U.S. Food and Drug Administration in...
Sermonix Doses First Patient in Phase 2 Clinical Trial of Lasofoxifene for Targeted Precision Medicine Treatment of Women With ESR1 Mutations in Metastatic Breast Cancer
Biopharmaceutical company is partnering with Sysmex Inostics to identify appropriate study candidates with the OncoBEAM™ ESR1 liquid biopsy test COLUMBUS, Ohio, Sept. 23, 2019 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical...
Mustang Bio Announces Phase 1 Clinical Trial Evaluating MB-105 for Prostate Stem Cell Antigen-Positive Castration-Resistant Prostate Cancer Enrolling Patients at City of Hope
Mustang Bio, Inc. (“Mustang”) (MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, today announced that...
Ovid Therapeutics Announces Positive Initial Data from Ongoing ENDYMION Open-Label Extension Trial of Soticlestat in People with Rare Epilepsies
Sustained and Progressively-Improving Median Seizure Frequency Reduction Reaching 84-90% with Prolonged Treatment of Soticlestat in this Difficult-to-Treat Patient Population Soticlestat Continues to Advance in Rare Epilepsies; Initial Data from Phase 2 ARCADE Trial...
ZS Launches Clinical Design Center to Help Cross-Functional Pharma Teams Accelerate Clinical Programs and Get New Therapies to Patients Faster
Global professional services firm ZS has launched Clinical Design Center, an integrated technology platform and services solution that allows cross-functional teams within pharmaceutical organizations to collaborate in a virtual environment to make better data-driven...
fishbat Explains How Live Video Can Help Expand Your Clinical Trial Globally
As technology has altered the way we communicate with each other, it is no secret that the written word has lost leverage in the eyes of content consumers. That is why video content, specifically live video, has superseded blog and written content in driving...
Phase 2 clinical trial of TORC1 inhibition with everolimus in men with metastatic castration-resistant prostate cancer.
Activation of the PI3K-Akt-mTOR signaling pathway is common in advanced castration resistant prostate cancer (CRPC), typically through PTEN loss. Preclinical studies suggest that Akt-driven CaP cells are genetically susceptible to mammalian target of rapamycin (mTOR,...
Trovagene Announces Successful Completion of Phase 1b Trial of Onvansertib in Acute Myeloid Leukemia (AML) and Initiation of Patient Enrollment in Phase 2
- Phase 1b dose escalation clinical trial confirmed safety, preliminary efficacy and identified the recommended phase 2 dose of onvansertib - Complete response (CR + CRi) achieved in 5 of 21 patients treated with onvansertib in combination with decitabine - Phase 2...
Foamix Announces Enrollment of First Patient in Phase 2 Acne Clinical Trial for FCD105 Minocycline 3% and Adapalene 0.3% Combination Foam
Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX), today announced that the first patient has been enrolled in its Phase 2 clinical trial to evaluate the efficacy and safety of its topical combination foam, comprised of minocycline 3% and adapalene 0.3%, FCD105 for the...
Cerevel Therapeutics to Present Results from a Phase 2 Study of Tavapadon in Patients with Early-stage Parkinson’s Disease
Data to be presented at the 2019 International Congress of Parkinson’s Disease and Movement Disorders Cerevel Therapeutics, a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, will present new data from a Phase 2 clinical trial...
Worldwide Clinical Trials Hires Aman Khera to Lead Global Regulatory Strategy
Worldwide Clinical Trials, Inc. (Worldwide), an award-winning, full-service, midsize, global contract research organization (CRO), announced today that Aman Khera joined the company’s Scientific Solutions team as global head of regulatory strategy. Khera will lead...
Graybug Vision Initiates Clinical Trial in Macular Edema Secondary to Diabetic Macular Edema or Retinal Vein Occlusion
Graybug Vision, Inc., a clinical stage pharmaceutical company developing potentially transformative long-acting therapies for ocular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and...
Study quantifies impact of NIH-sponsored trials on clinical cancer care
A new study shows that nearly half of phase 3 cancer clinical trials carried out by the National Cancer Institute (NCI)-sponsored SWOG Cancer Research Network, one of five groups in NCI’s National Clinical Trials Network (NCTN), were associated with clinical care...
Vertical Pharmaceuticals LLC, an Osmotica company, Announces Presentation of Phase III RVL-1201 Clinical Trial Data in Patients with Acquired Blepharoptosis (droopy eyelid)
Results from Three Pivotal Phase III Efficacy and Safety Trials (Studies RVL-1201-201, 202 and 203) to Be Presented at Multiple Global Congresses BRIDGEWATER, N.J., Sept. 18, 2019 (GLOBE NEWSWIRE) -- Vertical Pharmaceuticals, LLC (a subsidiary of Osmotica...
Imcyse to present first-in-human phase 1b study results in type 1 diabetes at EASD 2019
Company's insulin-based Imotope(TM) IMCY-0098 shows excellent safety profile and promising clinical trends LIÈGE, BELGIUM / ACCESSWIRE / September 18, 2019 / Imcyse, a clinical-stage company developing active and specific immunotherapeutics for the treatment and...
Immunic, Inc. Doses First Healthy Volunteer in its Phase 1 Clinical Program of IMU-935, a Potentially Best-in-Class RORgt Inverse Agonist
Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing potentially best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced dosing of the first healthy volunteer in the...
Biogen Advances Spinal Muscular Atrophy (SMA) Clinical Research with New Study Evaluating a Higher Dose of SPINRAZA® (nusinersen) and Additional Data in a Broad Range of Patients
DEVOTE trial to evaluate safety and even greater efficacy of a higher dose of SPINRAZA in the treatment of SMA; well-established safety profile supports exploration of potential benefits Long-term data from the SHINE study demonstrate improvements in or stabilization...
Zynerba Pharmaceuticals Announces Positive Top Line Data from BELIEVE 1 Open Label Phase 2 Study of Zygel™ in Developmental and Epileptic Encephalopathies (DEE)
- Study Achieves a 44% Median Seizure Reduction in Focal Impaired Awareness (Complex Partial) and Convulsive Seizures in DEE Patients by Month Two; Reductions were Sustained through Month Six of Treatment with Zygel - - At Least 42% of these Patients Experienced a...
Biogen Advances Spinal Muscular Atrophy (SMA) Clinical Research with New Study Evaluating a Higher Dose of SPINRAZA® (nusinersen) and Additional Data in a Broad Range of Patients
DEVOTE trial to evaluate safety and even greater efficacy of a higher dose of SPINRAZA in the treatment of SMA; well-established safety profile supports exploration of potential benefits Long-term data from the SHINE study demonstrate improvements in or stabilization...
Phase 2 Study Published in Ophthalmology Highlights Efficacy and Safety Data of Intravitreal APL-2 for Geographic Atrophy Secondary to Age-Related Macular Degeneration
Apellis Pharmaceuticals Inc., (APLS) a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, today announced details about its Phase 2 FILLY study...