Clinical Trials News


www.bloodjournal.org?w=16&cs=1876081726 Blood CLINICAL TRIALS AND OBSERVATIONS

Azacitidine maintenance after intensive chemotherapy improves DFS in older AML patients
The prevention of relapse is the major therapeutic challenge in older patients with acute myeloid leukemia (AML) who have obtained a complete remission (CR) on intensive chemotherapy. In this randomized phase 3 study (HOVON97) in older patients (≥60 years) with AML or myelodysplastic syndrome with refractory anemia with excess of blasts, in CR/CR with incomplete hematologic recovery (CRi) after at least 2 cycles of intensive chemotherapy, we assessed the value of azacitidine as postremission therapy…

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Thu Mar 28, 2019 18:00

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In The Lancet veröffentlichte Ergebnisse zeigen Nichtunterlegenheit von CT-P13 gegenüber Referenz-Infliximab bei chronisch-entzündlichen Darmerkrankungen
KOPENHAGEN, Dänemark–(BUSINESS WIRE)–Wie Celltrion Healthcare heute mitteilte, hat die Fachzeitschrift The Lancet die vollständigen Daten seiner randomisierten kontrollierten Studie (RCT) zu CT-P13 (Infliximab-Biosimilar) bei Morbus Crohn, die PLANETCD-Studie, veröffentlicht. Die Ergebnisse der Phase-III-Studie zeigen die Nichtunterlegenheit von CT-P13 gegenüber Referenz-Infliximab bei Biologika-naiven Patienten mit mittelschwerem bis schwerem Morbus Crohn.1 CT-P13 ist bereits für die Behandl

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Les données publiées dans The Lancet démontrent la non-infériorité du CT-P13 par rapport à l’infliximab de référence dans le traitement des maladies inflammatoires intestinales
COPENHAGUE, Danemark–(BUSINESS WIRE)–Celltrion Healthcare a annoncé aujourd’hui que The Lancet a publié l’intégralité des données de son essai contrôlé randomisé sur le CT-P13 (infliximab biosimilaire) dans le traitement de la maladie de Crohn (MC), intitulé PLANETCD. Les résultats de l’étude de Phase III ont démontré la non-infériorité du CT-P13 par rapport à l’infliximab de référence chez les patients atteints d’une forme modérée à sévère de MC et n’ayant jamais encore reçu d’agent biologiq

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Data Published in The Lancet Shows that CT-P13 is Non-inferior to Reference Infliximab in Inflammatory Bowel Disease
COPENHAGEN, Denmark–(BUSINESS WIRE)–Celltrion Healthcare announced today that The Lancet has published the full data-set from its randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease (CD), the PLANETCD Study. Results from the phase III study demonstrated the non-inferiority of CT-P13 to reference infliximab in biologic-naïve patients with moderate-to-severe CD.1 CT-P13 is already approved for the treatment of eight autoimmune diseases including CD, a form of

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Uit gegevens gepubliceerd in The Lancet blijkt dat CT-P13 niet inferieur is aan referentiegeneesmiddel infliximab bij inflammatoire darmaandoening
KOPENHAGEN, Denemarken–(BUSINESS WIRE)–Celltrion Healthcare heeft vandaag bekendgemaakt dat The Lancet de volledige dataset heeft gepubliceerd van haar gerandomiseerde gecontroleerde studie (RCT) van CT-P13 (biosimilar infliximab) bij de ziekte van Crohn (CD), de PLANETCD-studie. Resultaten van het fase III-onderzoek toonden de non-inferioriteit aan van CT-P13 ten opzichte van referentiegeneesmiddel infliximab bij patiënten die naïef waren voor biologicals met matige tot ernstige CD.1 CT-P13

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I dati pubblicati sulla rivista The Lancet dimostrano che CT-P13 non è inferiore all’infliximab di riferimento nel trattamento delle malattie infiammatorie intestinali
COPENAGHEN, Danimarca–(BUSINESS WIRE)–Celltrion Healthcare ha annunciato oggi che The Lancet ha pubblicato i dati completi del suo studio controllato e randomizzato (RCT) PLANETCD su CT-P13 (infliximab biosimilare) sulla malattia di Crohn (MC). I risultati di fase III dello studio hanno dimostrato la non inferiorità di CT-P13 rispetto all’infliximab di riferimento nei pazienti naïve al trattamento biologico con MC da moderata a severa.1 CT-P13 è già approvato per il trattamento di otto malatt

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Datos publicados en The Lancet demuestran que CT-P13 no es inferior al Infliximab de referencia para el tratamiento de la enfermedad inflamatoria intestinal.
COPENHAGUE, Dinamarca–(BUSINESS WIRE)–Celltrion Healthcare ha anunciado hoy que The Lancet ha publicado el primer conjunto completo de datos sobre su estudio controlado aleatorizado (RCT) de CT-P13 (biosimilar Infliximab) en la enfermedad de Crohn, el estudio PLANETCD. Los resultados del estudio de Fase III demostraron la no inferioridad de CT-P13 respecto al Infliximab de referencia en pacientes que reciben por primera vez tratamientos biológicos, con enfermedad de Crohn de moderada a grave.

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Gilead and Galapagos Announce Filgotinib Meets Primary Endpoint in the Phase 3 FINCH 3 Study in Methotrexate-Naïve Rheumatoid Arthritis Patients
FOSTER CITY, Calif. and MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24 results of FINCH 3, an ongoing, randomized, double-blind, active-controlled Phase 3 study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis. FINCH 3 evaluated filgotinib in combination with methotrexate and as monotherapy in

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Thu Mar 28, 2019 23:04


Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study
FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced Week 24 results of FINCH 1, an ongoing, randomized, double-blind, placebo- and active-controlled Phase 3 study of filgotinib, an investigational, oral, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis. FINCH 1 evaluated filgotinib versus adalimumab or placebo, on a stable…

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Thu Mar 28, 2019 23:03


Gilead and Galapagos Report Updated Safety Information for Filgotinib in Rheumatoid Arthritis (RA)
FOSTER CITY, Calif. & MECHELEN, Belgium–(BUSINESS WIRE)–regulated information – Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today also announced interim safety information from four studies of the investigational compound filgotinib for the treatment of rheumatoid arthritis (RA). The data include 24 week results of the ongoing Phase 3 FINCH 1, 2, and 3 trials, and updated Week 156 safety data from the Phase 2b DARWIN 3 long term extension study in patie

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Thu Mar 28, 2019 23:02


vTv Therapeutics to Present at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases
HIGH POINT, N.C.–(BUSINESS WIRE)–vTv Therapeutics to present at the 14th International Conference on Alzheimer’s & Parkinson’s Diseases.

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Thu Mar 28, 2019 22:30


Veracyte Announces Participation in the 18th Annual Needham Healthcare Conference
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte Announces Participation in the 18th Annual Needham Healthcare Conference

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Thu Mar 28, 2019 22:15


Treace Medical Announces Publication of Additional Positive Clinical Data Supporting Lapiplasty® 3D Bunion Correction™
PONTE VEDRA, Fla.–(BUSINESS WIRE)–Treace Medical Concepts, Inc., a medical device company focused on advancing the standard of care for hallux valgus (bunion) surgery, announces publication of additional positive clinical data supporting Lapiplasty® 3D Bunion Correction™ in The Journal of Foot & Ankle Surgery. The objective of the study was to evaluate bone healing with an accelerated weightbearing protocol in patients undergoing fusions of the tarsometatarsal joint (“3-plane Lapidus fusi

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Thu Mar 28, 2019 22:00


First US Patient Treated with Cook Medical’s Recently Approved Zenith® Dissection Endovascular System
BLOOMINGTON, Ind.–(BUSINESS WIRE)–Following the recent FDA approval of Cook Medical’s Zenith Dissection Endovascular System, Cooper University Health Care in Camden, New Jersey, has treated the first patient in the US with the device as part of Cook’s US commercial launch. “We are committed to helping patients by developing a variety of treatment options for aortic disease,” said Mark Breedlove, vice president of Cook Medical’s Vascular division. “We’re pleased to provide US clinicians and pa

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Thu Mar 28, 2019 21:18

Advaxis Announces Reverse Stock Split
PRINCETON, N.J.–(BUSINESS WIRE)–Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced that its Board of Directors has approved a one-for-fifteen (1-for-15) reverse stock split of its common stock that will become effective tomorrow, March 29, 2019, upon the filing of a Certificate of Amendment to its Certificate of Incorporation with the Secretary of the State of Delaware. Beginnin

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Thu Mar 28, 2019 19:00


SpinalCyte to Provide Clinical Trial Update at the 2019 International Society for the Advancement of Spine Surgery Annual Meeting
HOUSTON–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/celltherapy?src=hash" target="_blank"gt;#celltherapylt;/agt;–SpinalCyte, LLC, a Texas-based regenerative medicine company focused on regrowth of the spinal disc using Human Dermal Fibroblasts (HDFs), today announced that Thomas Ichim, Ph.D., SpinalCyte’s Chief Scientific Officer, will present at the 2019 International Society for the Advancement of Spine Surgery Annual Meeting (ISASS19) on Thursday, April 4, 2019 at 7:50 a.m. PDT in…

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Thu Mar 28, 2019 16:37


Eccrine Systems Announces Collaboration with Maxim Integrated Products
CINCINNATI–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/biotech?src=hash" target="_blank"gt;#biotechlt;/agt;–Eccrine Systems announces collaboration with Maxim Integrated Products.

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Thu Mar 28, 2019 14:45


Odonate Therapeutics Initiates CONTESSA TRIO
SAN DIEGO–(BUSINESS WIRE)–Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, today announced the initiation of CONTESSA TRIO, a multi-cohort, multicenter, Phase 2 study of tesetaxel, Odonate’s investigational, orally administered taxane. In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic T

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Thu Mar 28, 2019 14:30


Puma Biotechnology Announces Publication of Abstracts on Neratinib for AACR Annual Meeting 2019
LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology and its collaborators will present data on its drug neratinib at the AACR Annual Meeting 2019, which begins on March 29.

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Thu Mar 28, 2019 14:30

Imbrium Therapeutics Announces U.S. FDA Orphan Drug Designation for Tinostamustine for the Treatment of T-cell Prolymphocytic Leukemia
STAMFORD, Conn.–(BUSINESS WIRE)–Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue Pharma L.P., in conjunction with Mundipharma EDO GmbH, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational drug tinostamustine, a potentially first-in-class alkylating deacetylase inhibiting molecule being studied in early phase clinical trials, for the treatment of T-cell prolymph

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Thu Mar 28, 2019 14:30


Velicept Therapeutics Announces Positive Top-Line Phase 2b Results for Solabegron in the Treatment of Overactive Bladder (OAB)
WAYNE, Pa.–(BUSINESS WIRE)–Velicept Therapeutics, a privately-held specialty pharmaceutical company dedicated to the development of best-in-class compounds for the treatment of urological and gastrointestinal disorders, announced that its next generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a Phase 2b study in patients with overactive bladder (OAB). In the study, twice-daily administration of solabegron demonstrated a statistically significant improveme

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Thu Mar 28, 2019 14:30


HemaCare and Tissue Solutions Announce Strategic Partnership to Expand Access to Human Disease-State Samples
LOS ANGELES & GLASGOW, Scotland–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/apheresis?src=hash" target="_blank"gt;#apheresislt;/agt;–HemaCare and Tissue Solutions Announce Strategic Partnership to Expand Access to Human Disease-State Samples

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Thu Mar 28, 2019 14:10


Xcovery Announces the Appointment of Li Mao as Chief Executive Officer and Giovanni Selvaggi as Chief Medical Officer
PALM BEACH GARDENS, Fla.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/CEO?src=hash" target="_blank"gt;#CEOlt;/agt;–Xcovery Announces the Appointment of Li Mao as Chief Executive Officer and Giovanni Selvaggi as Chief Medical Officer

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Thu Mar 28, 2019 14:00


Adaptive Biotechnologies and Collaborators to Highlight New immunoSEQ Data at AACR 2019
SEATTLE–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/AACR19?src=hash" target="_blank"gt;#AACR19lt;/agt;–Adaptive Biotechnologies and its collaborators will present 11 studies, including an oral presentation and 10 poster presentations, at the American Association of Cancer Research (AACR) Annual Meeting in Atlanta, GA, March 29 – April 3. New data will demonstrate how immunosequencing at scale and with precision using Adaptive’s immunoSEQ® Assay may be used in clinical trials to predict…

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Thu Mar 28, 2019 14:00


Bacteremia – Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019 – ResearchAndMarkets.com
DUBLIN–(BUSINESS WIRE)–The "Bacteremia – Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019" drug pipelines has been added to ResearchAndMarkets.com’s offering. This report provides comprehensive insights about marketed and Phase III products for Bacteremia. The report includes information of marketed products including their product description, patent details, forecasted sales till 2021 & API manufacturer details by country. Global API Manufacturers of Marketed Produ

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Thu Mar 28, 2019 13:24


Tricida Announces Positive Results From Long-Term Clinical Trial of TRC101 in Patients With CKD and Metabolic Acidosis
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida announces positive results from long-term clinical trial of TRC101 in patients with CKD and metabolic acidosis.

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Thu Mar 28, 2019 13:15


Tricida Announces $200 Million Debt Facility With Hercules Capital
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida announces $200 million debt facility with Hercules Capital.

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Thu Mar 28, 2019 13:07


Tricida Announces Fourth Quarter and Full-Year 2018 Financial Results
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida announces fourth quarter and full year 2018 financial results.

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Thu Mar 28, 2019 13:00


Biolinq Expands Series A Financing With $4.75 Million Investment
SAN DIEGO–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/Aphelion?src=hash" target="_blank"gt;#Aphelionlt;/agt;–Biolinq Expands Series A Financing with $4.75 Million Investment

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Thu Mar 28, 2019 13:00


Seattle Genetics to Host Conference Call on Positive Topline Results from Pivotal Trial of Enfortumab Vedotin
BOTHELL, Wash.–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) will host a conference call and webcast discussion regarding the positive topline results from its pivotal clinical trial of enfortumab vedotin in locally advanced or metastatic urothelial cancer, which were announced in a press release earlier today. Access to the event can be obtained as follows: LIVE access on Thursday, March 28, 2019 6:00 a.m. Pacific Time (PT) / 9:00 a.m. Eastern Time (ET) Telephone 866-288-0540 (domesti

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Thu Mar 28, 2019 13:00


Janssen souhaite élargir l’utilisation de la thérapie combinée au DARZALEX®▼ (daratumumab) pour les patients atteints d’un myélome multiple récemment diagnostiqué éligibles à une greffe
BEERSE, Belgique–(BUSINESS WIRE)–Les sociétés pharmaceutiques Janssen de Johnson & Johnson ont annoncé aujourd’hui la soumission d’une demande de modification de type II à l’Agence européenne des médicaments (EMA) pour le DARZALEX®▼ (daratumumab) en association avec du bortézomib, du thalidomide et de la dexaméthasone (VTd) pour les patients atteints d’un myélome multiple récemment diagnostiqué et éligibles à une greffe autologue de cellules souches (AGCS). La soumission est étayée par le

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Thu Mar 28, 2019 12:34


Janssen chiede di estendere l’uso della terapia combinata con DARZALEX®▼ (daratumumab) ai pazienti con mieloma multiplo di diagnosi recente eleggibili al trapianto
BEERSE, Belgio–(BUSINESS WIRE)–Le società farmaceutiche Janssen di Johnson & Johnson hanno oggi annunciato la presentazione di una richiesta di variazione di tipo II all’Agenzia europea per i medicinali (EMA) per DARZALEX®▼ (daratumumab) in combinazione con bortezomib, talidomide e desametasone (VTd) per il trattamento dei pazienti con mieloma multiplo di nuova diagnosi eleggibili al trapianto di cellule staminali autologhe (ASCT). La richiesta è supportata dai dati dello studio di fase 3

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Thu Mar 28, 2019 12:34


BrainScope Completes Large-Scale Clinical Studies of Concussion in Universities, High Schools and Concussion Clinics
BETHESDA, Md.–(BUSINESS WIRE)–lt;a href="https://twitter.com/hashtag/concussion?src=hash" target="_blank"gt;#concussionlt;/agt;–BrainScope completes algorithm development & clinical validation studies for concussion assessment and readiness to return to activities ages of 13-25

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Thu Mar 28, 2019 12:00


Initial results from the EMPRISE real-world study of empagliflozin compared with DPP-4 inhibitors presented at ACC.19 and AMCP 2019
INGELHEIM, Germany, & INDIANAPOLIS, Ind.–(BUSINESS WIRE)–Initial results from the EMPRISE real-world study of empagliflozin compared with DPP-4 inhibitors presented at ACC.19 and AMCP 2019

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Thu Mar 28, 2019 09:07


Seattle Genetics and Astellas Announce Positive Topline Results from Pivotal Trial of Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer
BOTHELL, Wash. & TOKYO–(BUSINESS WIRE)–Seattle Genetics, Inc. (Nasdaq:SGEN) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the first cohort of patients in a pivotal phase 2 single-arm clinical trial known as EV-201. The cohort is evaluating enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received previous treatment with both platinum-contain

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Thu Mar 28, 2019 09:01

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www.clinicalconnection.com?w=16&cs=2003410936 ClinicalConnection.com New Clinical Trials

Uterine Fibroids – Miami FL
Uterine fibroid study for women experiencing strong pain during her periods.

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ClinicalConnection.com New Clinical Trials

Thu Mar 28, 2019 00:00

Psoriasis – Sherman Oaks CA
Oral medication for psoriasis one year long study with 18 visits.

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ClinicalConnection.com New Clinical Trials

Wed Mar 27, 2019 00:00

Clinical Trials Survey
Would you like to help improve the clinical trial experience for general diseases patients? We are interested in your opinions about reporting your symptoms for clinical trials. Please click the link below to complete this short, 5-minute survey. Your anonymous responses will be used for research purposes to better understand how to improve patient care. Complete the survey and provide your email address to be entered to win a $100 Visa gift card!

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Thu Mar 28, 2019 00:00

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Merck invests in expansion of manufacturing capacity for biotech medicines
The investment will cover a new building dedicated to Merck biotech medicines destined for more than 150 countries, helping to meet increasing patient needs for flagship medicines such The post Merck invests in expansion of manufacturing capacity for biotech medicines appeared first on Pharmaceutical Business review.

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AstraZeneca’s Forxiga approved in Japan for type-1 diabetes
Elisabeth Björk, Senior Vice President, Head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, said: “This approval of Forxiga in Japan means that people with type-1 diabetes whose The post AstraZeneca’s Forxiga approved in Japan for type-1 diabetes appeared first on Pharmaceutical Business review.

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Thu Mar 28, 2019 11:32

Silence seeks UK MHRA approval to launch first-in-human study of SLN124
SLN124 is being developed for the treatment of iron overload disorders like ß -Thalassemia, Myelodysplastic syndrome (MDS) and Hereditary Hemochromatosis (HH). The investigational candidate was demonstrated to reduce The post Silence seeks UK MHRA approval to launch first-in-human study of SLN124 appeared first on Pharmaceutical Business review.

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Thu Mar 28, 2019 11:32

Cancer Research UK, LifeArc, Ono Pharma establish new drug discovery alliance
The multimillion-pound drug discovery alliance will bring together Cancer Research UK’s network of scientists and drug discovery expertise, LifeArc’s therapeutic antibody engineering and development expertise and Ono’s expertise The post Cancer Research UK, LifeArc, Ono Pharma establish new drug discovery alliance appeared first on Pharmaceutical Business review.

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Thu Mar 28, 2019 11:32

MedPharm to develop new XF-drug formulations
These new treatments for dermal and ocular infections are part of its second clinical programme to address the global problem of anti‐microbial resistance (AMR). MedPharm is a world The post MedPharm to develop new XF-drug formulations appeared first on Pharmaceutical Business review.

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Thu Mar 28, 2019 09:35

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