Commercial

Flexion Therapeutics Announces Full Commercial Launch and Nationwide Availability of ZILRETTA™ (triamcinolone acetonide extended-release injectable suspension)

November 20, 2017

BURLINGTON, Mass., Nov. 20, 2017 (GLOBE NEWSWIRE) — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the full commercial launch of ZILRETTA™ (triamcinolone acetonide extended-release injectable suspension), the company’s new therapy for the management of pain associated with osteoarthritis (OA) of the knee. On October 6, 2017, ZILRETTA was approved by the U.S. Food and Drug Administration, […]

CRF Health’s TrialMax Touch® Selected by Leading Specialty Pharmaceutical Company for Pediatric Rare Disease Phase II Study

November 20, 2017

Plymouth Meeting, PA – November 14, 2017:  CRF Health, the leading global provider of patient-centered eSource technology and service solutions for the life sciences industry, has been selected by a leading specialty pharmaceutical company for its latest pediatric rare disease Phase II study. The trial will utilize CRF Health’s TrialStudio®, TrialMax® and TrialManager® eCOA solutions […]

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 […]

MindBytes BVBA Initiates Oncology R&D Program Focused on Patient Empowerment and is Selected as One of Five Finalists for Astellas Oncology C3 Prize

November 16, 2017

EDMONTON, Alberta & GHENT, Belgium–(BUSINESS WIRE)–MindBytes BVBA and its subsidiary, MindLab Interactive AI Inc., (“MindBytes”) today announced it has initiated an oncology research & development program focused on empowering individuals with cancer and improving their lives. The Company plans to develop an interactive Cancer Patient Decision Aid (CADA) and an evidence-based serious game for breast […]

Cardinal Health Launches Opioid Action Program to Support Drug Abuse Prevention and Education in Appalachia

November 16, 2017

Company to Collaborate with Key Partners across Ohio, Kentucky, Tennessee and West Virginia DUBLIN, Ohio, Nov. 16, 2017 /PRNewswire/ — Cardinal Health (NYSE: CAH) today launched its new Opioid Action Program, aimed at helping communities in four of the nation’s hardest-hit states across Appalachia combat the opioid epidemic. The pilot program will deliver much needed […]

FDA Announces New Draft REMS Guidance

November 16, 2017

Last week, FDA Commissioner Scott Gottlieb announced new draft guidance on risk evaluation and mitigation strategies (REMS) programs. The draft guidance provides for a single shared Drug Master File submission for all manufacturers of the same drug, which eliminates duplicative paperwork. This draft guidance is part of the FDA’s new two-pronged approach to address REMS […]

Otsuka And Proteus® Announce The First U.S. FDA Approval Of A Digital Medicine System: ABILIFY MYCITE® (aripiprazole tablets with sensor)

November 16, 2017

ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE® Patch (wearable sensor); the MYCITE APP (a smartphone application); and web-based portals for healthcare providers and caregivers(1)  The system records medication […]

EUSA Pharma and AVEO Oncology Announce the First Commercial Launch of FOTIVDA® (tivozanib)

November 15, 2017

HEMEL HEMPSTEAD, England & CAMBRIDGE, Mass.–(BUSINESS WIRE)–EUSA Pharma and AVEO Oncology (NASDAQ:AVEO) today announced the first commercial launch of FOTIVDA® (tivozanib) with the initiation of product sales in Germany. In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC) and for […]

FASLODEX® (fulvestrant) Receives US FDA Approval for the Treatment of Advanced Breast Cancer in Combination with Abemaciclib

November 15, 2017

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication for FASLODEX® (fulvestrant), expanding the indication to include use with abemaciclib, a CDK4/6 inhibitor, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) in women […]

Connected Wearable Patch Shipments to Reach 35.1 Million Units Annually by 2022, According to Tractica

November 15, 2017

BOULDER, Colo.–(BUSINESS WIRE)–Connected wearable patches include patches, tattoos, or small devices that are affixed to the skin and worn for a limited time, from an hour to several weeks. The patches also have an element of wireless connectivity, and have a medical, health, or wellness purpose that can range from monitoring physiological data to delivering […]

Fasenra (Benralizumab) Receives US FDA Approval For Severe Eosinophilic Asthma

November 15, 2017

WILMINGTON, Del., November 14, 2017) – AstraZeneca (NYSE:AZN) and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved FASENRA™ (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. FASENRA is not approved […]

Former CenterWatch COO Joan Chambers Joins SCORR Marketing as Senior Strategic Advisor

November 14, 2017

Kearney, Neb., Nov. 14, 2017 (Business Wire) — SCORR Marketing, a global health science marketing and communications firm, has announced the appointment of Joan Chambers as senior strategic advisor. In her role, Chambers will capitalize on her extensive health science industry experience to provide strategic direction to SCORR’s global clients to help them meet their […]

Grand River Aseptic Manufacturing Announces Majority Investment by Arlington Capital Partners

November 14, 2017

Grand Rapids, Mich., Nov. 14, 2017 (Business Wire) — Grand River Aseptic Manufacturing (GRAM), a leading provider of high-quality, sterile parenteral solutions, has a new majority owner: Arlington Capital Partners, a private equity firm in the Washington, D.C., area. Among other things, the new partnership will provide funding for GRAM to expand and add capacity […]

FDA Renews and Expands its Portfolio of Simcyp Simulator (PBPK) Licenses

November 14, 2017

Increased Use of Physiologically-based Pharmacokinetic (PBPK) Modeling and Simulation (M&S) is a Priority in Both the Prescription Drug User Fee Act and Generic Drug User Fee Amendments Certara®, the global leader in model-informed drug development and regulatory science, today announced that the US Food and Drug Administration (FDA) has greatly expanded its use of Certara’s […]

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