Latest News on Clinical Trials
BIOGEN ANNOUNCES AGREEMENT TO ACQUIRE NIGHTSTAR THERAPEUTICS TO ESTABLISH CLINICAL PIPELINE OF GENE THERAPY CANDIDATES IN OPHTHALMOLOGY
-Biogen (Nasdaq: BIIB) today announced that it has entered into an agreement to acquire Nightstar Therapeutics (NST; Nasdaq: NITE), a clinical-stage gene therapy company based in London, United Kingdom, which is focused on adeno-associated virus (AAV) treatments for...
Completion of Clinical Trial – a Significant Achievement for Medicortex Finland
-Medicortex Finland Oy (http://www.medicortex.fi), a biotechnology company developing a diagnostic kit for brain injury detection based on a medical breakthrough biomarker, completed collection of samples in its second large clinical study. The trial recruited...
VGS Completes Enrollment of VEST U.S. Pivotal Trial for the Evaluation of Its Venous External Support Technology for Coronary Bypass Surgery
Vascular Graft Solutions Ltd. (VGS) announces the completion of patient enrollment in the company's US Investigational Device Exemption (IDE) randomized, controlled pivotal study, evaluating the efficacy of the VEST external support for saphenous vein grafts in...
I-Mab Biopharma Announces the Achievement of First Patient Dosing in Phase 1b/2a China Trial of TJ107 for Cancer and Chemotherapy-induced Lymphopenia
- A Potential Global First-in-Class Long-Acting Recombinant IL-7 Immunotherapy I-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases,...
Evaluating Cognition in Parkinson’s Disease Clinical Trials: Key Considerations for Study Design and Conduct, New Webinar Hosted by Xtalks
The symptoms of cognitive impairment in people with Parkinson’s Disease (PD) are significant. In this webinar, the featured speakers will address important trends in the identification of patient populations suitable for trials of cognition-enhancing or...
Kura Oncology Announces FDA Clearance of Investigational New Drug Application for Menin-MLL Inhibitor KO-539
– KO-539 is a potent, selective small molecule inhibitor of the menin-MLL interaction – – Robust anti-tumor activity observed in mixed lineage leukemias rearranged and oncogenic driver mutations in genes such as NPM1 – – Phase 1 clinical trial in relapsed or...
BioPharmX Completes Enrollment in Phase 2b Trial of BPX-04 for Patients with Papulopustular Rosacea
Company anticipates announcing topline efficacy and safety results in July 2019 SAN JOSE, Calif., March 4, 2019 /PRNewswire/ -- BioPharmX Corporation (NYSE American: BPMX), a specialty pharmaceutical company focused on developing innovative medical dermatology...
Clovis Oncology Announces Availability of Rubraca®▼ (rucaparib) Tablets for Women with Relapsed Ovarian Cancer in Germany
Rubraca® (rucaparib) offers a new monotherapy maintenance treatment option for eligible women with platinum-sensitive relapsed ovarian cancer, regardless of BRCA status Rucaparib provided statistically significant improvement in progression-free survival (PFS) versus...
Bimekizumab Demonstrated Long-Term Maintenance of Complete or Almost Complete Skin Disease Resolution for Psoriasis Patients in BE ABLE 2 Extension Study
- 80 to 100% of BE ABLE 1 responders maintained a response of at least 90% disease improvement (PASI90) over 60 weeks with bimekizumab - These positive results mark the longest-term data to date demonstrating durable PASI90/PASI100 outcomes to 60 weeks with...
Biogen Announces Agreement to Acquire Nightstar Therapeutics to Establish Clinical Pipeline of Gene Therapy Candidates in Ophthalmology
Biogen to acquire Nightstar Therapeutics for $25.50 per share Nightstar Therapeutics is a gene therapy company focused on developing novel treatments for patients suffering from rare inherited retinal diseases that would otherwise lead to blindness Nightstar has two...
Oncotelic Reports Clinical Validation of Drug Induce Xenogenization (DIX) For Treatment of Glioblastoma and Pancreatic Cancer (PC)
Phase 2 Clinical Data Presented at ASCO-SITC Clinical Immuno-Oncology Symposium Xenogenization through chemotherapy-induced genetic mutations (alkylating agents such as temozolomide) or drug-induced immunologic cell death can be effectively leveraged to for successful...
SELLAS Life Sciences Announces Presentation of Final Data Analysis from Phase 2b Study of Nelipepimut-S Plus Trastuzumab at the 2019 ASCO-SITC Clinical Immuno-Oncology Meeting
SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) (“SELLAS” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, today announced final results from the efficacy...
Tetra Bio-Pharma and Santé Cannabis Announce Completion of the First Phase 2 Cannabis Oil Trial in Cancer and Non-Cancer Patients
Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V: TBP) (OTCQB: TBPMF), a global leader in cannabinoid-derived drug development and discovery, is pleased to announce completion of the first double-blind, randomized and placebo-controlled Phase 2 clinical trial...
FDA Grants Rolling Review for CytoDyn’s Planned BLA for Investigational HIV Therapy Leronlimab (PRO 140)
CytoDyn Inc. (OTC.QB: CYDY), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced that the FDA has reviewed and accepted CytoDyn’s request and plan to submit on a...
Apellis Resumes Dosing in Its Phase 3 Program for Patients with Geographic Atrophy
No inflammation observed in ten patients dosed in Phase 1b trial with new intravitreal APL-2 drug product from modified manufacturing process Apellis Pharmaceuticals Inc. (Nasdaq:APLS), a clinical-stage biopharmaceutical company focused on the development of novel...
Axsome Therapeutics Initiates MOMENTUM Phase 3 Trial of AXS-07 in Migraine
First patient enrolled in the MOMENTUM study Trial being conducted under FDA Special Protocol Assessment (SPA) Topline results anticipated in 1Q 2020 Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for...
Rexahn Announces Target Enrollment Reached in Phase 2a Clinical Trial of RX-3117 in Combination With ABRAXANE® in First-line Metastatic Pancreatic Cancer Patients
Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical-stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, announced that is has completed enrollment in the Phase 2a clinical trial...
Verrica Pharmaceuticals Presents Positive Results from Two Phase 3 Clinical Trials of VP-102 in Late-Breaking Oral Presentation at the 2019 American Academy of Dermatology Meeting
– CAMP-1 and CAMP-2 trials of VP-102 for the treatment of molluscum contagiosum successfully met their primary endpoints – – Molluscum contagiosum is a highly contagious, significantly undertreated viral skin disease that affects approximately six million people in...
Hua Medicine completes patient enrollment for Phase III monotherapy trial of dorzagliatin
Hua Medicine (HKEX: 2552), a Shanghai-based drug development company focused on developing a global first-in-class oral drug for the treatment of Type 2 diabetes, announced today the completion of patient enrollment for a Phase III monotherapy trial of HMS5552...
LYNPARZA® (olaparib) Receives Positive EU CHMP Opinion For Use in Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer
AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending the use of LYNPARZA...
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