TOKYO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO : 4519) a annoncé que l’Agence européenne des médicaments (EMA) a accepté la demande d'autorisation de mise sur le marché du satralizumab, (code de développement : SA237), un anticorps de recyclage humanisé anti-récepteur de l'interleukine-6 (IL-6), pour le traitement de patients adultes et adolescents atteints de maladie du spectre de la neuromyélite optique (neuromyelitis optica spectrum disorder, NMOSD). L'EMA a accordé le statut
08:04
TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519), hat bekannt gegeben, dass die Europäische Arzneimittel-Agentur (EMA) den Zulassungsantrag für Satralizumab (Entwicklungscode: SA237), einen humanisierten, rezyklierenden Interleukin-6- bzw. IL-6-Rezeptor-Antikörper, zur Behandlung von erwachsenen und jugendlichen Patienten mit Neuromyelitis-optica-Spektrum-Erkrankungen (NMOSD) entgegengenommen hat. Die EMA hat Satralizumab den Status zur beschleunigten Bearbeitung gewährt. D
08:04
Clinical Trials, Ahead of Print. Background/aims:Clinical trial oversight is central to the safety of participants and production of robust data. The United Kingdom Medical Research Council originally set out an oversight structure comprising three committees in 1998. The first committee, led by the trial team, is hands-on with trial conduct/operations (‘Trial Management Group’) and essential. The second committee (Data Monitoring Committee), usually completely independent of the trial, reviews accumulating...
08:05
PITTSBURGH, Oct. 29, 2019 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (Nasdaq:KRYS), a gene therapy company dedicated to developing and commercializing novel treatments for patients suffering from rare dermatological diseases, today...
Tue Oct 29, 2019 06:10
SAN FRANCISCO, Oct. 23, 2019 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN), today announced the dosing of the first patient in the LAPIS Phase 3 clinical study of pamrevlumab in patients with unresectable locally advanced...
Wed Oct 23, 2019 03:10
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE) October 16, 2019 -- Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory...
Wed Oct 16, 2019 03:10
OSAKA, Japan & FLORHAM PARK, N.J.–(BUSINESS WIRE) October 2, 2019 – Shionogi & Co., Ltd. (hereafter “Shionogi”) today announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical...
Wed Oct 02, 2019 03:10
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, today announced the pricing of its initial public offering of 3,000,000 shares of common stock at a public offering price of $12.00 per share. In addition, the underwriters have been gran
02:49
HOUSTON--(BUSINESS WIRE)-- October 29, 2019 Vapogenix, a clinical-stage company developing a new class of topical non-opioid, lidocaine-free analgesics, today announced results of a Phase II clinical trial of its lead product, VPX638, which...
Wed Oct 30, 2019 01:10
FOSTER CITY, Calif. & SHANGHAI--(BUSINESS WIRE) October 29, 2019 -- Terns Pharmaceuticals, Inc., a global biopharmaceutical company focused on discovering and developing innovative therapies to treat non-alcoholic steatohepatitis (NASH) and...
Wed Oct 30, 2019 01:10
NEW YORK, Oct. 23, 2019 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative immuno-oncology cancer therapies, today announced that the Company has enrolled its...
Thu Oct 24, 2019 02:10
BOTHELL, Wash.--(BUSINESS WIRE) October 21, 2019 -- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive topline results from the HER2CLIMB trial, a randomized, double-blind, placebo-controlled, active comparator pivotal trial evaluating...
Tue Oct 22, 2019 02:10
SAN DIEGO--(BUSINESS WIRE)--ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that it has initiated the Phase 3 LAVENDER placebo-controlled study to evaluate the efficacy and safety of trofinetide for girls and young women with Rett syndrome. Rett syndrome is a serious and rare neurodevelopmental congenital CNS d
Wed Oct 30, 2019 22:15
MENLO PARK, Calif.--(BUSINESS WIRE)--Personalis to Announce Third Quarter 2019 Financial Results on November 13, 2019
Wed Oct 30, 2019 22:05
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) today announced its third quarter 2019 financial results and provided an update on the company, including its progress with IPI-549, a first-in-class oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective phosphoinositide-3-kinase-gamma (PI3K-gamma) inhibition. “It is an exciting and important time for Infinity as we anticipate completing enrollment in M
Wed Oct 30, 2019 22:03
CONCORD, Calif.--(BUSINESS WIRE)--Cerus Corporation (Nasdaq: CERS) today announced financial results for the third quarter ended September 30, 2019. Recent developments and highlights include: FDA issued its final guidance document on strategies to mitigate the risk of bacterial contamination in transfused platelet components Total third quarter revenue of $22.8 million Quarterly product revenue of $18.0 million, a 17% increase compared to the prior year quarter Government contract revenue of $
Wed Oct 30, 2019 22:01
LAVAL, Quebec--(BUSINESS WIRE)--Per conto dello sponsor, Acurx Pharmaceuticals, Altasciences è orgogliosa di aver portato a termine con successo la conduzione clinica, la gestione dati e la programmazione SAS per ACX-362E, un nuovo agente antibatterico orale per il trattamento dell'infezione da Clostridioides difficile (CDI), un'infezione intestinale acuta, grave e potenzialmente mortale. Altasciences ha reclutato in modo efficiente e trattenuto 62 soggetti sani e normali per questa sperimentaz
Wed Oct 30, 2019 21:57
OXFORD, England--(BUSINESS WIRE)--Perspectum is excited to unveil new data at The Liver Meeting® 2019, highlighting the diagnostic capabilities of their FDA-cleared imaging products.
Wed Oct 30, 2019 21:56
SANTA CLARA, Calif.--(BUSINESS WIRE)--Cardiva Medical, Inc., an innovator in the field of vascular closure, today announced that positive results from the AMBULATE pivotal study demonstrating the safety and efficacy of the company’s VASCADE® MVP Venous Vascular Closure System compared to manual compression were published online in the Journal of the American College of Cardiology: Clinical Electrophysiology. The company also announced that it has received CE Mark certification in Europe for VAS
Wed Oct 30, 2019 20:57
If you or a loved one have gastrointestinal stromal tumors (GIST), you may want to learn more about the intrigue clinical research study. What is the purpose of the intrigue study? The purpose of the intrigue study is to evaluate an investigational drug, ripretinib (DCC-2618), as a potential new treatment option for patients living with GIST. The study is being done to learn more about the safety of ripretinib and how well it works against GIST, as compared to Sutent® (sunitinib), in patients...
Wed Oct 30, 2019 00:00
COLLEGE STATION, Texas--(BUSINESS WIRE)--STATKING Clinical Services, Cincinnati, OH is among the top 100 companies from around the world selected for the 15th annual Aggie 100 List.
Wed Oct 30, 2019 19:53
LAVAL, Quebec--(BUSINESS WIRE)--Altasciences meldet stolz den erfolgreichen Abschluss der klinischen Prüfung, Datenverwaltung und SAS-Programmierung für ACX-362E im Auftrag seines Sponsors Acurx Pharmaceuticals. ACX-362E ist ein neuartiger, oraler, antibakterieller Wirkstoff zur Behandlung der Clostridium difficile-Infektion (CDI), einer akuten, schwerwiegenden und potenziell lebensbedrohlichen Darminfektion. Für diese randomisierte, doppelblinde, placebokontrollierte Erststudie der Phase I am
Wed Oct 30, 2019 18:57
NORTHBROOK, Ill.--(BUSINESS WIRE)--Pamela Landau, Senior Vice President of Integrated Solutions at Continuum Clinical named to PharmaVOICE 100.
Wed Oct 30, 2019 17:24
LAVAL, Québec--(BUSINESS WIRE)--Au nom du sponsor, Acurx Pharmaceuticals, Altasciences est fier d’avoir achevé avec succès la réalisation clinique, la gestion des données et la programmation SAS d’ACX-362E, un nouvel agent de traitement antibactérien oral de l'infection à clostridium difficile (ICD), une infection intestinale aiguë, grave, potentiellement mortelle. Altasciences a efficacement recruté et retenu 62 sujets sains pour ce premier essai à doses multiples ascendantes, randomisé, contr
Wed Oct 30, 2019 17:07
NOTTINGHAM, England--(BUSINESS WIRE)--Tufts white paper indicates Quotient Sciences' Translational Pharmaceutics® platform reduces development times and lowers R&D costs.
Wed Oct 30, 2019 15:00
WILMINGTON, N.C.--(BUSINESS WIRE)--PPD launches SiteCoach training, providing new patient treatment options, accelerating development of life-changing medicines.
Wed Oct 30, 2019 15:00
SEAL BEACH, Calif.--(BUSINESS WIRE)-- #activesurveillance--Dendreon announced early completion of patient enrollment of its Phase 3 ProVent clinical trial.
Wed Oct 30, 2019 15:00
Chronic Traumatic Encephalopathy or CTE is a degenerative brain disease, thought to be caused, in part, by repetitive head impacts, such as those sustained by playing football. At this time, CTE can only be diagnosed after death through an autopsy. The DIAGNOSE CTE Research Project is designed to try and develop methods of diagnosing CTE during life, as well as examining specific risk factors for getting CTE. Participation includes a 3-day visit to one of four sites (Boston, New York, Scottsdale,...
Wed Oct 30, 2019 00:00
Chronic Traumatic Encephalopathy or CTE is a degenerative brain disease, thought to be caused, in part, by repetitive head impacts, such as those sustained by playing football. At this time, CTE can only be diagnosed after death through an autopsy. The DIAGNOSE CTE Research Project is designed to try and develop methods of diagnosing CTE during life, as well as examining specific risk factors for getting CTE. Participation includes a 3-day visit to one of four sites (Boston, New York, Scottsdale,...
Wed Oct 30, 2019 00:00
Chronic Traumatic Encephalopathy or CTE is a degenerative brain disease, thought to be caused, in part, by repetitive head impacts, such as those sustained by playing football. At this time, CTE can only be diagnosed after death through an autopsy. The DIAGNOSE CTE Research Project is designed to try and develop methods of diagnosing CTE during life, as well as examining specific risk factors for getting CTE. Participation includes a 3-day visit to one of four sites (Boston, New York, Scottsdale,...
Wed Oct 30, 2019 00:00
Chronic Traumatic Encephalopathy or CTE is a degenerative brain disease, thought to be caused, in part, by repetitive head impacts, such as those sustained by playing football. At this time, CTE can only be diagnosed after death through an autopsy. The DIAGNOSE CTE Research Project is designed to try and develop methods of diagnosing CTE during life, as well as examining specific risk factors for getting CTE. Participation includes a 3-day visit to one of four sites (Boston, New York, Scottsdale,...
Wed Oct 30, 2019 00:00
Current medications for UC rely on suppressing the body's immune system. For some people, this approach may bring unwanted side effects or may not work well enough to treat symptoms. The ECO-RESET Study will look at an all-natural, non-pharma investigational medication that is designed to work differently, and which it is hoped will provide a new way to treat UC. Studies have shown that people with UC often have changes in the population of bacteria living in their intestines (guts), called the gut...
Tue Oct 29, 2019 00:00
A Phase 3, Multicenter, Randomized, Double-blind Trial of Brexpiprazole as Combination Therapy with Sertraline in the Treatment of Adults with Post-traumatic Stress Disorder
Tue Oct 29, 2019 00:00
A Multicenter, Randomized, Flexible-dose, Double-blind Trial of Brexpiprazole Versus Placebo for the Treatment of Adults With Borderline Personality Disorder
Tue Oct 29, 2019 00:00
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte Announces New Data Characterizing Genomic Alterations in Thyroid Cancer To Be Presented at American Thyroid Association Annual Meeting
Wed Oct 30, 2019 14:15
GAINESVILLE, Fla.--(BUSINESS WIRE)--Cyclo Therapeutics, Inc. (OTCQB: CTDH), a clinical-stage biotechnology company that develops cyclodextrin-based products for the treatment of Niemann-Pick Disease Type C and Alzheimer’s Disease, today announced that it has signed an agreement with Worldwide Clinical Trials (Worldwide), a leading Contract Research Organization (CRO), to conduct a clinical trial to evaluate safety and efficacy in Alzheimer’s Disease. The trial will evaluate Trappsol® Cyclo™ giv
Wed Oct 30, 2019 14:00
PARAMUS, N.J.--(BUSINESS WIRE)--PGI Drug Discovery LLC (PsychoGenics), announced today that it has received milestone payments from Sunovion Pharmaceuticals Inc. (Sunovion) associated with the advancement of two compounds into clinical testing - SEP-378614 and SEP-380135, bringing the total to four compounds now being studied in clinical trials for people living with neuropsychiatric conditions. "We are pleased to see the continued progress of these compounds that hold promise for people living
Wed Oct 30, 2019 14:00
Δεν υπάρχουν σχόλια:
Δημοσίευση σχολίου