Clinical Development

Xencor Doses First Patient in Phase 1 Study of XmAb®18087 Bispecific Tumor Targeting Antibody for the Treatment of Neuroendocrine Tumors and Gastrointestinal Stromal Tumors

February 23, 2018

MONROVIA, Calif., Feb. 22, 2018 /PRNewswire/ — Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, today announced that the first patient has been dosed in a Phase 1 clinical trial of XmAb®18087, a bispecific antibody for the treatment of […]

Daiichi Sankyo Initiates Phase 1 Study of DS-1062 in Patients with Advanced Non-Small Cell Lung Cancer

February 23, 2018

TOKYO, BASKING RIDGE, N.J. and MUNICH, Feb. 22, 2018 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced the first patient has been dosed in a phase 1 study assessing the safety and tolerability of DS-1062, an investigational TROP2-targeting antibody drug conjugate (ADC), in patients with unresectable advanced non-small cell lung cancer (NSCLC) […]

MYR Pharma Announces Completion of Active Treatment Phase in MYR 203 Clinical Trial of Myrcludex B

February 23, 2018

BURGWEDEL, Germany, Feb. 22, 2018 /PRNewswire/ — MYR Pharma GmbH today announced the completion of the 48-week-long active treatment phase in MYR 203 clinical trial, a part of Phase 2b program investigating Myrcludex B in combination with pegylated interferon (PEG INF) in chronic hepatitis Delta (HDV) infection. A total of 60 subjects enrolled into this […]

New Study Evaluates the Performance of Masimo SpHb® in Monitoring Pediatric Trauma Patients

February 23, 2018

IRVINE, Calif.–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Michigan State University evaluated the performance of noninvasive hemodynamic monitoring (NIHM) using Masimo noninvasive and continuous hemoglobin (SpHb®), as compared to invasive laboratory hemoglobin (LabHb) monitoring, in clinically stable pediatric trauma patients with solid organ injury.1   […]

OncoPep Announces Initiation of Phase 1b Clinical Trial of PVX-410 in Metastatic Triple Negative Breast Cancer

February 23, 2018

BOSTON–(BUSINESS WIRE)–OncoPep, Inc. today announced the initiation of a Phase 1b clinical trial evaluating its investigational vaccine product PVX-410 for the treatment of patients with metastatic triple negative breast cancer (TNBC) who are human leukocyte antigen A2 positive (HLA-A2+). The investigator-sponsored study led by Steven Isakoff, M.D., Ph.D., at Massachusetts General Hospital, will assess the […]

Emisphere Development Update

February 23, 2018

ROSELAND, N.J., Feb. 22, 2018 (GLOBE NEWSWIRE) — Novo Nordisk announced today the successful completion of the first phase 3a trial, PIONEER 1, with oral semaglutide, a once-daily oral formulation of the long-acting GLP-1 analog for the treatment of Type 2 diabetes, which utilizes Emisphere Technologies, Inc.’s (“Emisphere” or the “Company”) proprietary Eligen® Technology. A […]

GTx Phase 2 Enobosarm Clinical Trial Results in Stress Urinary Incontinence Accepted for Podium Presentation at SUFU

February 23, 2018

MEMPHIS, Tenn.–(BUSINESS WIRE)–GTx, Inc. (Nasdaq: GTXI) today announced the acceptance of an abstract on clinical results from an ongoing, open-label, Phase 2 proof-of-concept clinical trial evaluating enobosarm 3 mg in postmenopausal women with stress urinary incontinence (SUI). This study is the first clinical trial evaluating an orally-administered selective androgen receptor modulator (SARM) for SUI.   […]

Kadmon Announces Updated Positive Results from Phase 2 Study of KD025 in cGVHD

February 23, 2018

NEW YORK–(BUSINESS WIRE)–Kadmon Holdings, Inc. (NYSE: KDMN) today announced updated positive results from an ongoing Phase 2 clinical trial (KD025-208) evaluating KD025, its Rho-associated coiled-coil kinase 2 (ROCK2) inhibitor, in patients with chronic graft-versus-host disease (cGVHD). The results are being presented today in an oral presentation at the BMT Tandem Meetings in Salt Lake City. […]

Basilea reports clinical phase 3 study start with antibiotic ceftobiprole in skin infections under BARDA contract

February 23, 2018

Basel, Switzerland, February 23, 2018  Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that it has commenced enrollment in the first of its two planned clinical phase 3 registration studies of the antibiotic ceftobiprole. The first study evaluates the safety and efficacy of the antibiotic in the treatment of adult patients with acute bacterial skin and […]

Bayer Announces Publication of Larotrectinib Data in The New England Journal of Medicine

February 22, 2018

WHIPPANY, N.J., Feb. 21, 2018 /PRNewswire/ — Bayer and Loxo Oncology, Inc., (NASDAQ: LOXO) today announced the publication in The New England Journal of Medicine (NEJM) of larotrectinib data for pediatric and adult patients whose tumors harbor Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusions. These genetic alterations are present across a wide range of tumors […]

Vertex Initiates First Phase 3 Study of VX-659, Tezacaftor and Ivacaftor as a Triple Combination Regimen for People with Cystic Fibrosis

February 22, 2018

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it is initiating the first Phase 3 study of VX-659, tezacaftor and ivacaftor as an investigational triple combination regimen for people with cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation. The study will enroll 360 patients, and the primary endpoint of […]

Ferring Pharmaceuticals and MSD Announce Completion of Largest Clinical Trial Ever Conducted in Postpartum Haemorrhage

February 22, 2018

SAINT-PREX, Switzerland, & KENILWORTH, N.J.–(BUSINESS WIRE)–Ferring Pharmaceuticals and MSD, known as Merck & Co., Inc., Kenilworth, N.J., U.S.A., through its MSD for Mothers initiative, today announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO). CHAMPION is investigating whether Ferring’s […]

Loxo Oncology Announces Publication of Larotrectinib Clinical Data in The New England Journal of Medicine

February 22, 2018

STAMFORD, Conn., Feb. 21, 2018 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, and Bayer AG, Germany, today announced a publication in the February 22nd issue of the New England Journal of Medicine (NEJM) for larotrectinib in the treatment of […]

Bioclinica Delivers Individual Case Safety Report (ICSR) Processing with Quality and Consistency While Crossing One Million Case Milestone in 2017

February 22, 2018

Quality and value in Bioclinica ICSR outsourcing enable drug safety operations to meet global regulatory requirements for safety monitoring of medicines PRINCETON, NJ– Bioclinica®, the world-leading provider of scientific- and technology-enabled solutions for clinical research, today announces its ICSR team delivered quality and consistency in Individual Case Safety Report (ICSR) processing while crossing the one […]

PharmaMar’s Lurbinectedin ATLANTIS trial design and data in small-cell lung cancer will be an oral presentation at the IASCLC´s annual meeting

February 21, 2018

MADRID, Feb. 20, 2018 /PRNewswire/ —   Dr Anna Farago, oncologist from the Massachusetts General Hospital and principal investigator of the phase III ATLANTIS clinical trial, will present the potential of lurbinectedin in small-cell lung cancer along with the main clinical data on safety and efficacy. The phase III Atlantis clinical study for recurrent small-cell […]

Centrexion Therapeutics Announces First Patient Dosed in Phase 3 Trial of CNTX-4975 for the Treatment of Moderate to Severe Knee Osteoarthritis Pain

February 21, 2018

BOSTON–(BUSINESS WIRE)–Centrexion Therapeutics Corporation, a company focused on developing non-opioid, non-steroidal therapeutics for the treatment of chronic pain, today announced that the first patient has been dosed in its Phase 3 VICTORY-1 clinical trial of CNTX-4975, a synthetic, ultra-pure injection of trans-capsaicin, for the treatment of chronic moderate to severe pain due to knee osteoarthritis […]

TG Therapeutics, Inc. Announces Publication of Clinical Data from the Phase 1 First-in-Human Trial of Umbralisib in The Lancet Oncology

February 21, 2018

NEW YORK, Feb. 21, 2018 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX) announced the publication of the results from the Phase 1 first-in-human study of umbralisib (TGR-1202), the Company’s novel once-daily PI3K delta inhibitor, in The Lancet Oncology. The paper includes safety and efficacy information from 90 patients with relapsed or refractory b-cell malignancies, including […]

DrugDev Introduces Consent Engineering, the Clinical Trials Industry’s First Truly SaaS Solution for Creating, Managing and Automating Informed Patient Consent In-House

February 21, 2018

Simple yet robust technology tools are primed to change completely the way pharmaceutical companies and CROs develop, implement and track patient consent across global clinical trial sites Today at the 2018 SCOPE Summit for Clinical Operations Executives, DrugDev (an IQVIA company) unveiled the industry’s first truly SaaS solution for electronic patient informed consent. Consent Engineering, […]

Menlo Therapeutics’ Phase 2 Serlopitant Study for the Treatment of Chronic Pruritus Published in the Journal of the American Academy of Dermatology

February 20, 2018

REDWOOD CITY, Calif., Feb. 20, 2018 (GLOBE NEWSWIRE) — Menlo Therapeutics Inc. (NASDAQ:MNLO), a late-stage biopharmaceutical company focused on the development of serlopitant, for the treatment of pruritus associated with various underlying dermatologic conditions and for refractory chronic cough, today announced that data assessing the safety and efficacy of serlopitant, the company’s NK-1 receptor antagonist, […]

Fate Therapeutics Announces First Subject Treated with FATE-NK100 in DIMENSION Study for Advanced Solid Tumors

February 20, 2018

SAN DIEGO, Feb. 20, 2018 (GLOBE NEWSWIRE) — Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the first subject has been treated in the DIMENSION study of FATE-NK100 for the treatment of advanced solid tumors. The clinical trial is […]

Achieve Announces Preliminary Data from Cytisine Phase I/II Multi-Dose, Pharmacokinetic and Pharmacodynamics (PK/PD) Clinical Study

February 20, 2018

BOTHELL, Wash. and VANCOUVER, British Columbia, Feb. 20, 2018 /PRNewswire/ — Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisine for smoking cessation, today announced preliminary data from their Phase I/II multi-dose, pharmacokinetic and pharmacodynamics (PK/PD) clinical study of cytisine.   The study, initiated in […]

Kancera AB (publ) Reports Positive Results from a Phase I Study in Healthy Subjects With its Lead Immunoregulating Drug Candidate KAND567

February 20, 2018

STOCKHOLM, February 20, 2018 /PRNewswire/ —   KAND567 is an orally available small molecule that blocks CX3CR1, the Fractalkine receptor. Fractalkine is an immunomodulating factor, known as a chemokine, which transmits signals via the CX3CR1 receptor, thereby controlling the function of immune cells and cancer cells. The amount of Fractalkine and its receptor CX3CR1 has […]

GenSight Biologics Announces Publication of Positive Data from Phase I/II Trial and Long-Term Follow-up of GS010 in Ophthalmology, the Journal of the American Academy of Ophthalmology GS010 confirmed as safe and well tolerated 2 years after a single unilateral intravitreal injection

February 20, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:   “This first-ever scientific publication of clinical data with GS010 is a major step forward for patients afflicted with LHON – a blinding disease affecting those in the prime of their life” Tweet this GenSight Biologics (Paris: SIGHT) (Paris: SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering […]

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