R&D

Navitor Pharmaceuticals to Develop NV-5138, a Specific Activator of mTORC1 for Treatment-Resistant Depression, Based on Promising Data Presented at Society for Neuroscience 2017

November 15, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Navitor Pharmaceuticals, Inc., a biopharmaceutical company developing novel medicines that target the cellular nutrient signaling proteins regulating mTORC1 activation to treat serious diseases including neurological and fibrotic disorders, immunometabolism and certain rare diseases, announced today that its direct mTORC1 activator small molecule NV-5138, has been designated as the company’s lead drug candidate to […]

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 […]

Eftilagimod Alpha (LAG-3Ig Or IMP321) Pre-IND Meeting With the FDA

November 15, 2017

SYDNEY, Australia, Nov. 15, 2017 (GLOBE NEWSWIRE) — Prima BioMed Ltd (ASX:PRR) (NASDAQ:PBMD) (“Prima”) is pleased to announce that it held a Pre-Investigational New Drug Application (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) in November to discuss the regulatory pathway for the development of Eftilagimod Alpha (LAG-3Ig or IMP 321) in the […]

Akcea and Ionis Announce Acceptance of Marketing Applications in U.S., EU and Canada for Volanesorsen for the Treatment of FCS

November 15, 2017

CAMBRIDGE, Mass., Nov. 15, 2017 (GLOBE NEWSWIRE) — Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ:IONS), focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, today announced that all of its marketing applications for volanesorsen have been accepted for review in the U.S., EU […]

Navitor Pharmaceuticals to Develop NV-5138, a Specific Activator of mTORC1 for Treatment-Resistant Depression, Based on Promising Data Presented at Society for Neuroscience 2017

November 15, 2017

CAMBRIDGE, Mass., November 15, 2017 – Navitor Pharmaceuticals, Inc., a biopharmaceutical company developing novel medicines that target the cellular nutrient signaling proteins regulating mTORC1 activation to treat serious diseases including neurological and fibrotic disorders, immunometabolism and certain rare diseases, announced today that its direct mTORC1 activator small molecule NV-5138, has been designated as the company’s […]

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 […]

Elizabeth Iorns, Ph.D., CEO of Science Exchange Elected to the Board of Directors of the Drug, Chemical & Associated Technologies Association (DCAT)

November 15, 2017

Science Exchange, the world’s leading and most secure enterprise platform for outsourced research and development (R&D) services, announced today that Elizabeth Iorns, Ph.D., CEO of Science Exchange, has been elected to serve her first term on the Board of Directors of the Drug, Chemical & Associated Technologies Association (DCAT) beginning November 1, 2017. Members of […]

Immuno-oncology CRO secures Macrophage Pharma agreement

November 15, 2017

Aquila BioMedical Ltd., an innovative preclinical contract research organisation (CRO) now part of Concept Life Sciences group, has secured an extended agreement with UK-based biotech firm Macrophage Pharma Ltd. to support its preclinical immuno-oncology programmes. Macrophage Pharma’s Esterase Sensitive Motif™ (ESM™) technology enables delivery of novel, small molecule drug candidates to tumour associated macrophages in a selective […]

Record revenue for TraceLink fuelled by EMEA and India growth

November 15, 2017

North Reading, MA (November 14, 2017)—TraceLink Inc., the World’s Largest Track and Trace Network for connecting the life sciences supply chain and providing real-time information sharing for better patient outcomes, today announced financial and company results for the third quarter of 2017. Growth highlights for the third quarter of 2017 include: An 84 percent year-over-year increase […]

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