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Replimune Announces First Patient Enrolled in Phase 1 Clinical Trial of RP2 Alone and in Combination with Opdivo® in Advanced Cancer Patients
Replimune’s second product candidate to enter the clinic is an Immulytic™ that expresses an anti-CTLA-4 antibody-like protein WOBURN, Mass., Oct. 24, 2019 (GLOBE NEWSWIRE) -- Replimune Group Inc. (REPL), a biotechnology company developing oncolytic immuno-gene...
MaxCyte Advances Phase I Clinical Trial of Lead CARMA™ mRNA-based Cell Therapy to Third Cohort of Patients
MCY-M11 is being evaluated in relapsed/refractory ovarian cancer and peritoneal mesothelioma CARMA platform offers faster manufacturing speeds, broader therapeutic applications, combination opportunities and repeat dosing potential GAITHERSBURG, Md., Oct. 24,...
AMAG Pharmaceuticals Announces the Publication of the PROLONG Trial Evaluating 17-OHPC in the American Journal of Perinatology
WALTHAM, Mass., Oct. 25, 2019 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (AMAG) today announced that the results of PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) were published online in the American Journal of Perinatology. PROLONG was a randomized,...
TrialScope Acquires Clinical Trial Connect
Founder Mike Wenger to Join Staff as Vice President of Patient Engagement JERSEY CITY, NJ, US - Oct 24, 2019 - TrialScope, the global leader in transparency and disclosure compliance solutions, has acquired Clinical Trial Connect, a platform used by disease...
Aclaris Therapeutics’ A-101 45% Topical Solution Meets Primary and All Secondary Efficacy Endpoints in Second Successful Pivotal Phase 3 Clinical Trial for the Treatment of Common Warts (THWART-1)
If approved, A-101 45% Topical Solution would be the first FDA-approved prescription treatment for common warts Highly statistically significant results for the primary efficacy endpoint Highly statistically significant results for all secondary efficacy endpoints...
Tilray® Supports New Clinical Trial Evaluating the Efficacy of Medical Cannabis in Disorders Caused by Breast Cancer Treatment
First-of-its-kind trial will test the efficacy of cannabis as a treatment for taxane-induced peripheral neuropathy, which affects 67 percent of women undergoing breast cancer treatment NANAIMO, British Columbia--(BUSINESS WIRE)--Tilray, Inc. (NASDAQ: TLRY), a global...
SpringWorks Therapeutics Announces Initiation of Phase 2b ReNeu Clinical Trial of Mirdametinib in Children and Adults with Neurofibromatosis Type 1 (NF1)-Associated Plexiform Neurofibromas (NF1-PN)
STAMFORD, Conn., Oct. 24, 2019 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that the first...
First-Ever U.S. Pivotal Phase 3 Clinical Study in Eosinophilic Esophagitis (EoE) Completes: Takeda’s Investigational Therapy Meets Co-Primary & Key Secondary Efficacy Endpoints
Positive findings on clinical endpoints for Budesonide Oral Suspension (BOS) presented during ACG 2019 Presidential Plenary Session LEXINGTON, Mass., Oct. 28, 2019 /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc., ("Takeda") (TSE:4502/NYSE:TAK) announced today that...
MedRhythms Initiates Multi-Site Randomized Controlled Trial at the Nation’s Top Rehab Hospitals for Its Post-Stroke Walking Rehabilitation Device
5-Center Study of the Device is Intended to Provide Clinical Data in Support of MedRhythms’ FDA Submission. PORTLAND, Maine--(BUSINESS WIRE)--MedRhythms, Inc., a Portland, Maine-based digital therapeutics company, today announced the launch of its 5-site randomized...
NurOwn® Data Safety Monitoring Board Recommends ALS Phase 3 Clinical Trial Continue
NEW YORK, Oct. 28, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Phase 3 clinical trial independent Data Safety Monitoring Board...
GeoVax Vaccine To Be Used in a Phase 1 Trial of Genetically Modified Autologous Cell Therapy for HIV
IND Application Submitted to FDA for Phase 1 Trial ATLANTA, GA, Oct. 24, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – GeoVax Labs, Inc. (OTCQB: GOVX) announced today its participation in a planned clinical trial led by researchers at American Gene Technologies (AGT)...
Mustang Bio Announces Dosing of First Participant in Phase 1 Clinical Trial of MB-108 (Oncolytic Virus C134) to Treat Glioblastoma
NEW YORK, Oct. 24, 2019 (GLOBE NEWSWIRE) -- 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...
Aerie Pharmaceuticals Completes Enrollment in the Phase 2 Trial of AR-1105 (Dexamethasone Intravitreal Implant) in Patients with Macular Edema Associated with Retinal Vein Occlusion Ahead of Schedule
DURHAM, N.C.--(BUSINESS WIRE)--Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie), an ophthalmic pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with open-angle glaucoma,...
Adverum Biotechnologies Doses First Patient in Third Cohort of OPTIC Phase 1 Clinical Trial of ADVM-022 Intravitreal Gene Therapy for Wet AMDPatients in the Third Cohort of OPTIC will Receive a Single ADVM-022 Dose of 2 x 10 ^11 vg/eye
MENLO PARK, Calif., Oct. 24, 2019 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc., (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that the first patient was dosed in the third cohort...
Gilead and Glympse Bio Announce Strategic Collaboration for Use of Biomarker Technology in NASH Clinical Development
FOSTER CITY, Calif. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Gilead Sciences Inc. (Nasdaq: GILD) and Glympse Bio, Inc., today announced that the companies have entered into a strategic collaboration in nonalcoholic steatohepatitis (NASH) clinical development. Glympse...
Segal Trials Acquires New Studies with Schedule 1 DEA License and Continues to Expand its Network of Inpatient and Outpatient Facilities
Segal Trials, a privately held network of research sites throughout South Florida and South Carolina conducting Phase I–IV trials, has been named one of seven sites to begin a Phase II study of psilocybin—a psychedelic prodrug compound—for major depressive disorder...
Influenza human challenge study begins at NIH-sponsored clinical trial units
A clinical trial in which healthy adults will be deliberately infected with influenza virus under carefully controlled conditions is recruiting volunteers at four Vaccine and Treatment Evaluation Units (VTEUs) supported by the National Institute of Allergy and...
SignalPath raises $18M to modernize the clinical trial process
Steven Loab for Vator writes: Clinical trials are one of the most important parts of the healthcare process. Not only are they used to discover potential new treatments for diseases, they can also help in finding ways to detect and diagnose those diseases. Clinical...
Talaris Therapeutics Announces Initiation of Phase 3 Clinical Trial of FCR001 in Living Donor Kidney Transplant Recipients
Talaris Therapeutics, Inc., a privately held biotechnology company developing transformative cell therapies that have the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients, today announced the initiation of FREEDOM-1, the...
Influenza human challenge study begins at NIAID-sponsored clinical trial units
A clinical trial in which healthy adults will be deliberately infected with influenza virus under carefully controlled conditions is recruiting volunteers at four Vaccine and Treatment Evaluation Units (VTEUs) supported by NIH's National Institute of Allergy and...