Clinical Development

5th Biennial Biosimilars & Biobetters Congress

November 22, 2017

Over the past editions our 5th Biennial Biosimilars & Biobetters Congress has built up a reputation for delivering high-level content and bringing together the top senior executives and leaders within the Biosimilar industry. We would like to share with you some of the many highlights you should not miss from our 2018 conference programme: Day […]

Clinical Trial Suggests New Cell Therapy For Relapsed Leukemia Patients

November 22, 2017

Instead of targeting a molecule called CD19 on the surface of the cancer cells, the new therapy targets a molecule called CD22. A significant proportion of children and young adults with treatment-resistant B-cell leukemia who participated in a small study achieved remission with the help of a new form of gene therapy, according by researchers […]

New Data Show Benefit of Tagrisso in Patients with EGFR-mutated Non-small Cell Lung Cancer and Central Nervous System Metastases

November 20, 2017

CAMBRIDGE, England–(BUSINESS WIRE)–AstraZeneca today presented new data from a subgroup analysis of the Phase III FLAURA trial, which explored osimertinib as 1st-line therapy in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Results presented at the ESMO Asia 2017 Congress in Singapore showed that patients with […]

Acorda Discontinues Tozadenant Development Program

November 20, 2017

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies. The Company made this decision based on new information obtained from the Phase 3 program related to previously […]

Phase III IMpower150 Study Showed Genentech’s Tecentriq (Atezolizumab) and Avastin (Bevacizumab) Plus Chemotherapy Significantly Reduced the Risk of Disease Worsening or Death in the Initial Treatment of People with a Type of Advanced Lung Cancer

November 20, 2017

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower150 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ® (atezolizumab) and Avastin® (bevacizumab) plus chemotherapy (paclitaxel and carboplatin) provided a statistically significant and clinically meaningful reduction in the risk […]

Genentech’s Hemlibra (Emicizumab-kxwh) Significantly Reduced Bleeds in Phase III Study in Hemophilia A

November 20, 2017

SOUTH SAN FRANCISCO, CA — 2017-11-19 00:00:00 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive results from the Phase III HAVEN 3 study evaluating HEMLIBRA® (emicizumab-kxwh) in adults and adolescents (aged 12 years or older) with hemophilia A without inhibitors to factor VIII. The study met its primary […]

Summit Completes Initial 24 Weeks of Dosing of Ezutromid in Patients With DMD in PhaseOut DMD Clinical Trial

November 20, 2017

Oxford, UK, 20 November 2017 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM) the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, announces the completion of the initial 24-weeks of dosing of ezutromid in patients with DMD in the Company’s Phase 2 clinical trial called PhaseOut DMD. […]

Deciphera Pharmaceuticals Reports Data from Ongoing Phase 1 Clinical Study of DCC-2618 at the 22nd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology

November 20, 2017

WALTHAM, Mass., Nov. 20, 2017 (GLOBE NEWSWIRE) — Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, today announced the presentation of data from its ongoing Phase 1 clinical trial of DCC-2618, the Company’s pan-KIT and PDGFRα inhibitor, in patients with malignant gliomas. The data were presented […]

ZIOPHARM Presents Positive Updated Results of Ad-RTS-hIL-12 Study in Brain Cancer at Society for Neuro-Oncology Annual Meeting

November 20, 2017

BOSTON, Nov. 20, 2017 (GLOBE NEWSWIRE) — ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company developing new gene and cell-based immunotherapies for cancer, today announced positive data updates supporting survival benefit and the underlying immune system mechanism for Ad-RTS-hIL-12 plus veledimex, the Company’s controlled human interleukin-12 (hIL-12) gene therapy candidate for brain cancer, at the 22nd […]

Geron Announces First Patient Dosed in Expanded Part 1 of IMerge Clinical Trial in Myelodysplastic Syndromes

November 20, 2017

MENLO PARK, Calif., Nov. 20, 2017 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq:GERN) today announced that the first patient has been dosed in the expanded Part 1 of IMerge, the ongoing Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who are refractory or resistant to treatment […]

WIRB-Copernicus Group Partners with Veeva Systems Inc.

November 20, 2017

WCG will create a seamless connection between WCG’s MyConnexus™ IRB document management web portal and Veeva Vault eTMF WIRB-Copernicus Group® (WCG™), the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research, today announced that it is partnering with Veeva Systems Inc. to improve the speed and accuracy of institutional review […]

Comprehend Systems Appoints New CEO in Response to Surging Demand for Clinical Intelligence Solutions; Enterprise Growth Expert to Scale Company and Expand Partner Ecosystem

November 20, 2017

Redwood City, Calif., November 13, 2017—Comprehend Systems, Inc., the leader in Clinical Intelligence solutions, has named Terry Cunningham CEO.  Cunningham will focus on scaling Comprehend in response to explosive customer demand for solutions that reduce time and risk in clinical trials. Cunningham will also drive expanded partner programs to help sponsors achieve faster, better clinical […]

How to avoid the 5 patient enrollment mistakes that delay clinical trials

November 16, 2017

Ever wonder why 80% of clinical trials are delayed? The top reason is unfulfilled enrollment, and there are specific reasons why this happens with so many trials This webinar will reveal 5 patient enrollment errors that stall enrollment timelines in trial after trial. More importantly, it will provide useful advice, based on proven methods, for […]

Acorda Provides Update on Tozadenant Development Program

November 15, 2017

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it has increased the frequency of blood cell count monitoring for participants to weekly in its Phase 3 program of tozadenant for Parkinson’s disease. The Company took this action in response to cases of agranulocytosis, possibly drug-related, and in some cases associated with sepsis and death. […]

Incyte Announces Initiation of Pivotal Clinical Trial of Ruxolitinib (Jakafi®) for the Treatment of Essential Thrombocythemia

November 15, 2017

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the first patient has been treated in the RESET pivotal trial evaluating ruxolitinib (Jakafi®) compared to anagrelide for the treatment of patients with essential thrombocythemia (ET) who are resistant to or intolerant of hydroxyurea (HU).   “We look forward to building on the clinical evidence for ruxolitinib […]

Moderna Announces First-in-Human Dosing for Phase 1 Study (KEYNOTE-603) of mRNA-4157, a Personalized Cancer Vaccine, for the Treatment of Solid Tumors

November 15, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna Therapeutics, a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced today that it has started dosing patients in a Phase 1 study of mRNA-4157, an mRNA-based personalized cancer vaccine. The Phase 1 open-label, dose escalation, multicenter study in […]

Critical Outcome Technologies Announces Pharmacokinetic Data From Phase 1 Dose Escalation Portion of COTI-2 Trial in Gynecological Malignancies

November 15, 2017

LONDON, ONTARIO and BOSTON, MASSACHUSETTS–(Marketwired – Nov. 15, 2017) – Critical Outcome Technologies Inc. (TSX VENTURE:COT)(OTCQB:COTQF) (“COTI” or the “Company”), a clinical stage biopharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, today announced pharmacokinetic (PK) data from the dose-escalation portion of its Phase 1 trial of COTI-2 in gynecological malignancies […]

Naia Rare Diseases Announces Clinical Trial Authorisation (CTA) to Initiate Clinical Trials of NB 1001 for Short Bowel Syndrome in the United Kingdom

November 15, 2017

RICHMOND, CA–(Marketwired – November 15, 2017) – Naia Rare Diseases, a biopharmaceutical company developing drugs for Short Bowel Syndrome (SBS) and other rare gastrointestinal diseases today announced that it has received Clinical Trial Authorisation (“CTA”) from the Medicine and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom to initiate a clinical trial of its […]

NuCana Announces First Patients Enrolled in Phase 2 Study of Acelarin in Platinum-Resistant Ovarian Cancer

November 15, 2017

EDINBURGH, United Kingdom, Nov. 15, 2017 (GLOBE NEWSWIRE) — NuCana plc (NASDAQ:NCNA) announced the enrollment of the first patients in both the United States and the United Kingdom in its PRO-105 study evaluating single-agent Acelarin (NUC-1031) in patients with platinum-resistant ovarian cancer. Hugh Griffith, NuCana’s Chief Executive Officer, stated: “The initiation of this Phase 2 […]

Enrolment of First Cohort Completed with Eighth Participant Dosed in Cynata’s World First Clinical Trial

November 15, 2017

MELBOURNE, Australia, Nov. 15, 2017 (GLOBE NEWSWIRE) — Australian stem cell and regenerative medicine company, Cynata Therapeutics Limited (ASX:CYP), is pleased to provide an update on the progress of the clinical trial of its lead Cymerus™ mesenchymal stem cell (MSC) product CYP-001. Key Highlights Eighth participant dosed in Cynata’s world first clinical trial of CYP-001 […]

Preclinical Studies with MyoKardia’s Mavacamten Demonstrate Evidence of Reduced Contractility and Improved Left Ventricular Compliance

November 15, 2017

SOUTH SAN FRANCISCO, Calif., Nov. 15, 2017 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq:MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, presented data that further elucidates the mechanism of action of the company’s lead drug candidate, mavacamten (formerly MYK-461) at this week’s American Heart Association (AHA) Scientific […]

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