Ketchum Launches Vital Health, Helping Healthcare Brands Become Healthier Themselves

July 17, 2018

NEW YORK, July 17, 2018 – Leading global communications consultancy Ketchum today unveiled its Vital Health suite of services, designed to help companies in the health sector find the root causes of their complex challenges and then imagine bold communications solutions that provide the best of health and business outcomes at the same time. The […]

Almac Group Invests in NMR Equipment to Enhance Existing Analytical Services Capability

July 17, 2018

Almac Group, the global contract development and manufacturing organisation, has announced a £375,000 investment in additional NMR instrumentation at its global Headquarters, Craigavon, UK. As part of Almac Sciences’ state-of-the-art cGMP facility, enhanced NMR services will be offered to help deliver comprehensive solutions supporting drug substance (API) and drug product development programs from early phase […]

Leading Alzheimer’s Disease scientist joins NeuroCog Trials

July 16, 2018

Dr. Kathleen Anne Welsh-Bohmer, a specialist in Alzheimer’s Disease (AD) research, has joined the scientific leadership team at NeuroCog Trials (NCT) as the Vice President of Neurodegenerative Disorders. In her new role she will lead the development of new technology and tools to support customers conducting clinical trials for dementia and other cognitive disorders. Having […]

Univercells raises €16 million in Series B financing round led by Global Health Investment Fund

July 16, 2018

Investment proceeds will support commercialization of the company’s breakthrough biologics manufacturing technology Brussels and New York, July 16, 2018 – Univercells SA (‘Univercells’) and Global Health Investment Fund (‘GHIF’) are pleased to announce the closing of a €16 million ($18.8M) Series B equity financing. Investment proceeds will support the continued development of Univercells’ game-changing biomanufacturing technology, […]

U.S. Food and Drug Administration Approves SIGA Technologies’ TPOXX® (tecovirimat) for the Treatment of Smallpox

July 14, 2018

NEW YORK, July 13, 2018 (GLOBE NEWSWIRE) — SIGA Technologies, Inc. (SIGA) (NASDAQ:SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the U.S. Food and Drug Administration (FDA) has approved oral TPOXX® (tecovirimat) for the treatment of smallpox to mitigate the impact of a potential outbreak. TPOXX, a small-molecule antiviral treatment […]

U.S. FDA Approves XTANDI® (enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)

July 13, 2018

TOKYO and NEW YORK, July 13, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI®(enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action […]

Didier Miraton joins CardioRenal’s supervisory board

July 13, 2018

Former CEO of Michelin and Pierre Fabre brings industry knowledge to telemedicine start-up, to assist in scaling up manufacturing capacities of its monitoring device for patients with severe heart failure Strasbourg, France, July 10, 2018 – CardioRenal, a major new player in telemedicine for patients with severe heart failure, today announces the arrival of Didier Miraton […]

Yposkesi appoints Dr. Fraser Wright as senior advisor

July 13, 2018

With extensive experience in gene therapy vector manufacturing, Dr. Wright, scientific co-founder and former CTO of Spark Therapeutics, will support Yposkesi’s innovation in viral vector design, production and characterization   Corbeil-Essonnes, near Paris, France, July 09, 2018 – Yposkesi, the largest European CDMO producing viral vectors (AAV and Lentivirus) for biopharmaceutical companies active in gene therapy, […]

Announcing AMPLEXOR’s July Webinar that Focuses on Transformation and Innovation in Regulatory Affairs

July 12, 2018

BROOMFIELD, Colo., USA — (12 July 2018) — AMPLEXOR Life Sciences continues its webinar program into the second half of 2018 with its next webinar on 27 July focusing on innovation in regulatory affairs. The webinar, presented by Venu Mallarapu, Head of Regulatory Affairs Advisory Consulting at Cognizant Technology Solutions and Romuald Braun, Vice President […]

Octave Bioscience Secures $14 Million Series A Financing Round

July 12, 2018

–George Scangos, PhD, and Michael Pellini, MD, Join Board of Directors, Bring Expertise in Chronic Neurodegenerative Markets and Molecular Insights for Improved Care– Menlo Park, CA, July 12 — Octave Bioscience, the developer of a fully integrated care management solution delivering powerful insights for patients with neurodegenerative diseases, today announced the completion of its Series […]

Bristol-Myers Squibb’s Opdivo® (nivolumab) + Low-Dose Yervoy® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin

July 12, 2018

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) today announced Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) […]

CMS Quit Test Of Pricey Cancer Treatment Amid Concerns Over Industry Role

July 12, 2018

Medicare and Medicaid administrators earlier this year quietly killed a plan to pay for a breakthrough, half-million-dollar cancer treatment based on how well it worked, scuttling one of the Trump’s administration’s first and most highly touted attempts to lower the cost of drugs. The payment deal for Swiss drug giant Novartis’ Kymriah therapy was suspended […]