ABBOTT PARK, Ill., Jan. 21, 2019/ PRNewswire/ Abbott today announced U.S. Food and Drug Administration approval of the TactiCath? Contact Force Ablation Catheter, Sensor Enabled?, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation. The approval further expands Abbott's portfolio of cardiac
AbbVie, a research-based global biopharmaceutical company, today announced an update on the Phase 3 RESOLVE trial of ibrutinib in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma. IMBRUVICA is a first-in-class...
NORTH CHICAGO- AbbVie, a research-based global biopharmaceutical company, today announced an update on the Phase 3 RESOLVE trial of ibrutinib in combination with chemotherapy agents nab-paclitaxel and gemcitabine versus placebo in combination with these chemotherapy agents in patients with metastatic pancreatic adenocarcinoma.
Achilles Therapeutics receives CTA approval for Phase I/II Study in Non-Small Cell Lung Cancer Ground-breaking clinical trial in patients with significant unmet medical need to start this year. Stevenage, UK 21 January 2019 Achilles Therapeutics, a biopharmaceutical company developing personalised cancer immunotherapies, today announces that its
ZUG, Switzerland& PETACH TIKVA, Israel Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, and Medison Pharma, Israel s leading commercial partner for innovative pharmaceuticals, announced today an exclusive agreement to commercialize ONPATTRO , the first-ever commercialized RNAi therapeutic, as well as other investigatio
Antibe Therapeutics Inc., a leader in developing safer therapeutics for pain and inflammation, is pleased to announce that it has received approval from Health Canada to initiate the second part of its Phase 2 B dose-ranging, efficacy study for its lead drug, ATB-346. The study will be conducted by Veristat, Inc. in approximately 35 clinical sites
Aurinia Pharmaceuticals Inc., a clinical stage biopharmaceutical company focused on the global immunology market, today announced it will report results before the opening of trading and hold a webcast and conference call to discuss the results of its Phase 2, double-masked, head-to-head study of VOS 0.2% versus Restasis to evaluate the efficacy
CAMBRIDGE- AVROBIO, Inc. a Phase 2 clinical-stage gene therapy company, today announced that its investigational gene therapy candidate for cystinosis, AVR-RD-04, is cleared to begin a Phase 1/ 2 clinical trial, following acceptance of the investigational new drug application by the U.S. Food and Drug Administration. The Phase 1/ 2 clinical trial i
BerGenBio ASA, announces that the first patient has been dosed in a phase I clinical trial evaluating the safety, tolerability, pharmacokinetics and anti-tumour efficacy of ADCT-601, an AXL-targeting antibody drug conjugate, in patients with advanced solid tumours. ADCT-601 is composed of a humanised monoclonal antibody against human AXL discover
ADCT-601 uses a proprietary AXL antibody developed by BerGenBio and licensed to ADC Therapeutics for antibody drug conjugate development. ADCT-601 is BerGenBio's third clinical candidate targeting AXL Bergen, Norway, January 21 2019- BerGenBio ASA, announces that the first patient has been dosed in a phase I clinical trial evaluating the safety
PETACH TIKVA- Can-Fite BioPharma Ltd., a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced that it has entered into a definitive agreement with a single institutional investor to receive gross proceeds of approximately $2.35 million.
LYON- ERYTECH Pharma, a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, announced that a poster entitled' TRYbeCA-1: A randomized, phase 3 study of eryaspase in combination with chemotherapy versus chemotherapy alone as second-line treatment in patients with...
Immunomedics Inc. said FDA issued a complete response letter for its BLA for sacituzumab govitecan to treat metastatic triple-negative breast cancer in a third-line setting. Shares of Immunomedics were off $4.78 to $13.31 for a loss of more than $900 million in market cap. Immunomedics said FDA is concerned about CMC issues, and will not require ne
GeNeuro, a biopharmaceutical company developing new treatments for neurological and autoimmune diseases such as multiple sclerosis and type-1 diabetes, today announced positive safety and tolerability results from a Phase 1 study assessing the administration of high doses of temelimab to treat MS and other auto-immune diseases.
According to this report, the Global Myasthenia Gravis market accounted for $1,215 million in 2017 and is expected to reach $3,651.25 million by 2026 growing at a CAGR of 13% during the forecast period. Based on geography, Asia Pacific region is expected to register highest market growth rate during the forecast period. Novartis Takeda Pharmaceutic
Graybug Vision, Inc., a clinical stage pharmaceutical company developing potentially transformative therapies for ocular diseases, today announced positive top line results for the ADAGIO study, a Phase 1/ 2 a study of intravitreal GB-102 in patients with wet age-related macular degeneration, the leading cause of blindness in the developed world fo
JW Pharmaceutical said Sunday that it had gained the South Korean drug regulators nod to begin domestic sales of the hemophilia treatment Hemlibra, developed by Chugai, a Roche-owned company. JW Pharmaceutical obtained an exclusive license to sell Hemlibra on the Korean market in 2017.. It was approved by the US Food and Drug Administration in Nove
SAN DIEGO- Kura Oncology, Inc., a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported new findings identifying a potential association between CXCL12 expression and clinical benefit in patients with pancreatic cancer treated with tipifarnib. These findings are being presented today at th
Clearside Biomedical, a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that data from MAGNOLIA, an extension study of PEACHTREE, its pivotal Phase 3 trial of XIPERE in patients with macular edema associated with non-infectious uveitis, was presented
-Clearside Biomedical, Inc., a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that data from MAGNOLIA, an extension study of PEACHTREE, its pivotal Phase 3 trial of XIPERE in patients with macular edema associated with non-infectious uveitis, was...
Slayback Pharma LLC announced today that it has launched its first commercial product Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml. This is the first and only ANDA approved by the FDA for Hydroxyprogesterone Caproate Injection in a multi-dose vial that is therapeutically equivalent to Makena. Hydroxyprogesterone Caproate Injection,
WiseGuyReports.com adds "Spinal Muscular Atrophy Market 2019 Global Analysis, Growth, Trends and Opportunities Research Report Forecasting 2025" reports tits database. Expected approval of gene therapy for treatment of spinal muscular atrophy is set to emerge as the game-changer in global spinal muscular atrophy therapeutics market. FDA approval of
Oslo, Norway, 21 January 2019- Targovax ASA, a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, announces that members of its senior management team will present at upcoming investor conferences. Targovax is a clinical stage biotechnology company developing immune activators to target...
NEW DELHI: Drug firm Wockhardt Monday said it has received approval from the US health regulator for generic version of Gleevec used for treatment of cancers and tumours. Wockhardt has received approval from the United States Food& Drug Administration for an abbreviated new drug application for 100 mg and 400 mg tablets of Imatinib Mesylate, the co
The Food and Drug Administration and the Central Ethics Committee in the United States have accepted Xbranes IND application for initiation of the Xplore trial, a phase III trial with Xlucane, a ranibizumab biosimilar candidate. 'It is with great satisfaction we can announce acceptance from the FDA and the Central Ethics Committee to initiate the X