LACHEN, Zwitserland--(BUSINESS WIRE)--Octapharma heeft een publicatie aangekondigd van nieuwe gegevens die aantonen dat het fibrinogeenconcentraat fibryga® een effectief alternatief is voor cryoprecipitaat voor patiënten met ernstige bloedingen tijdens een hartchirurgie. De gegevens zijn onlangs gepubliceerd in de Journal of the American Medical Association (JAMA).1 Overmatig bloeden is een grote zorg tijdens chirurgie en overmatig bloedverlies en/of stollingsfactorconsumptie kunnen leiden tot
Thu Oct 31, 2019 17:12
NEU-DELHI--(BUSINESS WIRE)--Nach ihrer ersten Kontaktaufnahme vor fast 18 Monaten und Abschluss der Vorphase haben AIIMS (Neu-Delhi, Indien) und Biolog-id (Paris, Frankreich) ein aus mehreren Phasen bestehendes Evaluierungsprotokoll im Bereich der Transfusionsmedizin, nämlich die Lösung Transfusion® von Biolog-id, erfolgreich fertiggestellt. Mit dieser Studie sollte innerhalb dieser renommierten Einrichtung das gesamte Management sowie die Rückverfolgbarkeit von Erythrozytenkonzentraten, angefa
Thu Oct 31, 2019 16:42
MONTREAL--(BUSINESS WIRE)--Laurent Pharmaceuticals receives an additional funding of up to US$ 3 million from the US-based Cystic Fibrosis Foundation
Thu Oct 31, 2019 16:00
DUBLIN--(BUSINESS WIRE)--Horizon announced that integrated data for teprotumumab for the treatment of active thyroid eye disease (TED) were presented at the ATA Annual Meeting
Thu Oct 31, 2019 16:00
WASHINGTON--(BUSINESS WIRE)-- #Brexit--The Association of Clinical Research Organizations (ACRO) has released two white papers on risk-based monitoring and risk based quality management, titled Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies and Risk Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight respectively. The first white paper outlines the results of a survey completed by ACRO members. Members...
Thu Oct 31, 2019 15:58
IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences Secures Substantial Financial Commitment, Commercial Infrastructure Support and Minority Shareholder Protections
Thu Oct 31, 2019 15:29
The collaboration will see the modular biologics and functional immunology expertise of Pandion combined with the advanced therapeutics development and global commercialisation capabilities of Astellas for the treatment The post Pandion, Astellas sign $900m deal for pancreas-targeted immunomodulators appeared first on Pharmaceutical Business review.
Thu Oct 31, 2019 15:26
LAVAL, Quebec--(BUSINESS WIRE)--Namens de sponsor, Acurx Pharmaceuticals, is Altasciences trots het klinische gedrag, gegevensbeheer en SAS-programmering met succes te hebben voltooid voor ACX-362E, een nieuw, oraal antibacterieel middel voor de behandeling van Clostridioides difficile-infectie (CDI), een acute, ernstige, mogelijk levensbedreigende darminfectie. Altasciences heeft op efficiënte wijze 62 gezonde normale personen aangeworven en behouden voor deze eerste menselijke proef, gerandom
Thu Oct 31, 2019 14:56
LAVAL, Quebec--(BUSINESS WIRE)--En nombre de su patrocinador, Acurx Pharmaceuticals, Altasciences se enorgullece de haber completado con éxito el ensayo clínico, la gestión de datos y la programación SAS para ACX-362E, un nuevo agente antibacteriano oral para el tratamiento de Clostridioides difficile (CDI), una infección intestinal aguda, grave, potencialmente mortal. Altasciences reclutó y retuvo con eficacia a 62 sujetos normales sanos para este primer estudio en humanos de fase I, aleatoriz
Thu Oct 31, 2019 14:52
LACHEN, Switzerland--(BUSINESS WIRE)--Octapharma has announced the publication of new data demonstrating that the fibrinogen concentrate fibryga® is an effective alternative to cryoprecipitate for patients with severe bleeding during cardiac surgery. The data were recently published in the Journal of the American Medical Association (JAMA).1 Excessive bleeding is a major concern during surgery, and excessive blood loss and/or clotting factor consumption can lead to deficiency in the coagulation
Thu Oct 31, 2019 14:04
HOUSTON--(BUSINESS WIRE)-- #celltherapy--InGeneron announces publication of encouraging preclinical data on regeneration of the heart after myocardial infarction for its cell therapy.
Thu Oct 31, 2019 14:03
MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX) provided HELP study update; expects full enrollment and top-line data in the first quarter of 2020.
Thu Oct 31, 2019 14:00
SAN DIEGO--(BUSINESS WIRE)--Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that it will report third quarter 2019 financial results after the U.S. financial markets close on Thursday, November 7, 2019. Oncternal’s management will host a webcast and conference call at 2:00 p.m. PST (5:00 p.m. EST) to discuss the Company’s financial results and provide a comprehensive business update.
Thu Oct 31, 2019 14:00
NASHVILLE, Tenn. & TOKYO & MUNICH & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo Initiates Clinical Trial with its 4th DXd Antibody Drug Conjugate, DS-7300, in Collaboration with Sarah Cannon Research Institute
Thu Oct 31, 2019 14:00
PALO ALTO, Calif.--(BUSINESS WIRE)--Medable Expands Executive Leadership Team with Clinical Trials Veteran Alison Holland
Thu Oct 31, 2019 14:00
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 its publication of the most extensive set of case studies to-date on expanded access use of hydroxypropyl beta cyclodextrin to treat patients with Niemann-Pick Disease Type C (NPC). The manuscript was published on October 21, 2019 in the Orphanet Journ
Thu Oct 31, 2019 14:00
Eureka Therapeutics to Present at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting
EMERYVILLE, Calif.--(BUSINESS WIRE)--Eureka Therapeutics to Present at the Society for Immunotherapy of Cancer (SITC) 34th Annual Meeting
Thu Oct 31, 2019 14:00
SAN FRANCISCO--(BUSINESS WIRE)--Shasqi Completes $10 Million Series A Financing
Thu Oct 31, 2019 14:00
WESTPORT, Conn.--(BUSINESS WIRE)--Intensity Therapeutics, Inc., a clinical-stage biotechnology company developing proprietary technology and products to kill tumors and increase immune system recognition of solid cancers, today announced that the first patient has been dosed with a combination of INT230-6, the Company’s lead investigational product, and Keytruda® (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy. The combination is being studied in a series of cohorts wit
Thu Oct 31, 2019 13:35
OXFORDSHIRE, England & CONSHOHOCKEN, Pa. & ROCKVILLE, Md.--(BUSINESS WIRE)--Immunocore Limited, a leading T cell receptor (TCR) biotechnology company, will present new data on its proprietary ImmTAC® platform and from the tebentafusp clinical research programme at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in National Harbor, Maryland from 7-10 November. Immunocore’s TCR technology generates a novel class of bispecific biologics called ImmTAC molecules that are designed...
Thu Oct 31, 2019 13:00
FRIENDSWOOD, Texas--(BUSINESS WIRE)--Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, today announced the presentation of results from a study validating a newly developed nomogram tool that combines information from the DecisionDx®-Melanoma test with clinicopathologic features to improve prediction of patients’ risk of melanoma recurrence. The study titled, “Development and validation of
Thu Oct 31, 2019 13:00
BRISBANE, Calif.--(BUSINESS WIRE)--Aimmune to Present New Data on Safety and Efficacy of AR101, Clinical Practice Implementation of Oral Immunotherapy, Quality of Life
Thu Oct 31, 2019 13:00
PETACH TIKVA, Israel--(BUSINESS WIRE)--U.S. FDA Agreed with Can-Fite’s Pivotal Phase III Trial Design to Support NDA Submission and Approval of Namodenoson in the Treatment of Liver Cancer
Thu Oct 31, 2019 13:00
VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia initiates AUDREY Phase 2/3 Clinical Trial
Thu Oct 31, 2019 12:30
Publication date: Available online 31 October 2019Source: Contemporary Clinical TrialsAuthor(s): John C. Fortney, Patrick J. Heagerty, Amy M. Bauer, Joseph M. Cerimele, Debra Kaysen, Paul N. Pfeiffer, Melissa J. Zielinski, Jeffrey M. Pyne, Deb Bowen, Joan Russo, Lori Ferro, Danna Moore, J.P. Nolan, Florence C. Fee, Tammy Heral, Jode Freyholtz-London, Bernadette McDonald, Jeremey Mullins, Erin Hafer, Leif SolbergAbstractObjectiveManaging complex psychiatric disorders like PTSD and bipolar disorder...
Thu Oct 31, 2019 12:31
Publication date: Available online 31 October 2019Source: Contemporary Clinical TrialsAuthor(s): Jun Yu, Dejian LaiAbstractOnce scientific questions are determined, other design features of clinical trials including increasing the power while controlling the type I error rate, planning interim analysis, and achieving treatment balance among subgroups will be either required or preferred. We propose to sequentially monitor the covariate adaptive randomization (CAR) procedures with sample size re-estimation...
Thu Oct 31, 2019 12:31
Publication date: Available online 30 October 2019Source: Contemporary Clinical TrialsAuthor(s): Guosheng Yin, Chenyang Zhang, Zhao YangAbstractIn several recent issues of The Lancet, we identified a few common pitfalls in the analysis of clinical trial and medical data in the published articles (Mok et al., 2019; Herrlinger et al., 2019; Reindl-Schwaighofer et al., 2019; He et al., 2019). Without careful validation of model assumptions, even the primary endpoint of the trial might be analyzed using...
Thu Oct 31, 2019 12:31
Publication date: Available online 30 October 2019Source: Contemporary Clinical TrialsAuthor(s): Jasper K.W. Gerritsen, Markus Klimek, Clemens M.F. Dirven, Esther Oomen, Michiel Wagemakers, Geert Jan M. Rutten, Alfred Kloet, Giorgio G. Hallaert, Arnaud J.P.E. VincentAbstractBackgroundGlioblastoma Multiforme (GBM) or astrocytoma's grade IV (WHO) are devastating tumors with one of the worst prognoses in oncology. Extending resection improves survival in patients with GBM. Surgery of GBM nowadays is...
Thu Oct 31, 2019 12:31
Validation confirms that the submission is complete and signifies the MAA is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The U.S. Food The post Roche’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA appeared first on Pharmaceutical Business review.
Thu Oct 31, 2019 12:27
Rett syndrome is a serious and rare neurodevelopmental congenital CNS disorder with symptoms that typically present between six to 18 months of age, and lead to problems with The post ACADIA Pharmaceuticals initiates phase 3 pivotal study of trofinetide in Rett Syndrome appeared first on Pharmaceutical Business review.
Thu Oct 31, 2019 12:27
ST. HELIER, Jersey--(BUSINESS WIRE)---- $NVCR #earnings--Novocure reported today financial results from third quarter 2019 and provided a company update.
Thu Oct 31, 2019 12:00
TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) kondigde aan dat het Europees Geneesmiddelenbureau (EMA) de aanvraag voor een vergunning voor het in de handel brengen van satralizumab (ontwikkelingscode: SA237), een anti-interleukine-6 (IL-6) receptorgehumaniseerd recyclage-antilichaam voor de behandeling van volwassen en adolescente patiënten met een neuromyelitis optica-spectrumstoornis (NMOSD), heeft aanvaard. Het EMA heeft de status van Accelerated Assessment toegekend
Thu Oct 31, 2019 11:25
TOKIO--(BUSINESS WIRE)--Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) ha anunciado que la Agencia Europea de Medicamentos (EMA) ha aceptado la solicitud de autorización de comercialización para satralizumab (código de desarrollo: SA237), un receptor anti-interleucina-6 (IL-6) humanizado de reciclaje de anticuerpos, para el tratamiento de pacientes adultos y adolescentes con trastorno del espectro de la neuromielitis óptica (NMOSD). La EMA ha otorgado el estatus de Evaluación Acelerada para satr
Thu Oct 31, 2019 11:25
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Pinteon Therapeutics, a company backed by $17 million in Series A funding, announced the launch of a Phase 1 trial of the novel tau antibody PNT001.
Thu Oct 31, 2019 11:00
東京--(BUSINESS WIRE)--(美國商業資訊)--中外製藥株式會社(Chugai Pharmaceutical Co., Ltd., TOKYO: 4519)宣布，歐洲藥品管理局(EMA)已受理satralizumab（開發代碼：SA237）的行銷授權申請，該藥是一種抗白介素6 (IL-6)受體人化回收型抗體，用於治療成人和青少年泛視神經脊髓炎(NMOSD)患者。EMA已授予satralizumab加速評估(Accelerated Assessment)狀態。美國食品藥品管理局(FDA)已受理satralizumab的生物製品執照申請(BLA)。EMA人用藥品委員會(CHMP)推薦和FDA決定預計於2020年出爐。 中外製藥執行副總裁、專案和生命週期管理聯席主管Yasushi Ito博士表示：「NMOSD是一種有高度未獲滿足醫療需求的疾病，疾病進展過程中可導致視覺損害和運動殘疾。satralizumab是一種試驗中藥物，作為單藥治療和添加至基線治療均顯示有臨床意義的治療效應。我們正與羅氏和各主管機關合作，儘早向患者提供這項新治療選擇。」 加速評估可縮短EMA和CHMP審理
Thu Oct 31, 2019 10:50
NUEVA DELHI--(BUSINESS WIRE)--Concluyendo la fase preliminar de una relación iniciada hace casi 18 meses, AIIMS (Nueva Delhi, India) y Biolog-id (París, Francia) han completado con éxito un protocolo de evaluación multifásica de la solución Biolog-id Transfusion®. Este estudio ha sido diseñado para validar dentro de esta prestigiosa institución, la gestión completa y trazabilidad de las bolsas de concentrado de hematíes (RBC) desde la calificación de sangre hasta la transfusión a un paciente. T
Thu Oct 31, 2019 10:36
Under the deal, Cheplapharm will acquire the commercial rights of Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release). The compound patent protection for Seroquel The post AstraZeneca to sell anti-psychotic medicine rights in Europe and Russia for $239m appeared first on Pharmaceutical Business review.
Thu Oct 31, 2019 10:27
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