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. 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 […]

FDA approves the first drug with an indication for treatment of smallpox

July 13, 2018

The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. Though the World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon. “To address the risk of […]

GRED Group invests €4 million in Germitec

July 13, 2018

GRED announces support for Germitec who will use the funds to accelerate rollout of Antigermix, a new disinfection method for medical instruments, compliant with the latest requirements for ultrasound probes   Ivry-sur-Seine, near Paris, France, July 10, 2018 — The GRED Group announces that it has provided financial support for Germitec, a company that develops and […]

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 […]

AZ Forges Surprise R&D Deal With Virus Gene Therapy Biotech

July 12, 2018

MedImmune, the R&D arm of AstraZeneca has teamed up with California based 4DMT, a next-generation virus-based gene therapy research house developing a treatment for chronic lung disease. The collaboration AstraZeneca announced today is the first, and quite unexpected step of the pharma giant into the adeno-associated virus (AAV) gene therapy, vector discovery and product development. […]

Pfizer to Organize for Future Growth

July 12, 2018

Pfizer Inc. (NYSE:PFE) today announced it will organize the company into three businesses: a science-based Innovative Medicines business which will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer and a Consumer Healthcare business. These changes […]

Wasdell Group launch serialisation service

July 12, 2018

The Wasdell Group (Wasdell), a leading outsourcing partner to companies within the pharmaceutical, medical device and clinical trials industries, has launched its serialisation service ahead of the EU FMD and US DSCSA implementation deadlines. Following a £2.8 million investment into serialisation capabilities in 2016, the company will offer compliant products to all markets, including Europe […]

Clinerion and the Precision Medicine-Hospital Information System Development Group of Korea University Medical Center collaborate on patient-data-driven solutions for precision medicine.

July 12, 2018

Clinerion and the Precision Medicine-Hospital Information System Development Group of Korea University Medical Center (P-HIS Development Group) sign a Memorandum of Understanding to support the development of the Korean national Precision Medicine Enterprise project with real-patient data solutions.   Clinerion has signed a Memorandum of Understanding with the P-HIS Development Group of Korea University Medical […]

Integreview IRB Adds Renowned Professor Emeritus to Team

July 11, 2018

IntegReview IRB announces that Ernest D. Prentice, Ph.D., has joined the organization as a Senior Consultant to the IRB. In his new role, Dr. Prentice will work with IntegReview leadership to provide consultation to the IRB and educate researchers by speaking at upcoming research conferences. “We are thrilled to work with someone as experienced and […]