The sBLA is based on results from the Phase III RADIANCE study that demonstrated treatment with Lucentis provided superior visual acuity gains in people with mCNV compared to
Under the collaboration deal, Transgene will sponsor a phase 1/2 study to assess its therapeutic vaccine candidate TG4001 together with Merck and Pfizer's immunotherapy avelumab to treat human
Under the collaboration, Takeda will provide EnGeneIC with an upfront access fee and research funding to explore the feasibility of the EDV technology for the development of immunomodulatory
Aprea Therapeutics AB president and CEO Christian Schade said: "The initiation of the Phase II clinical study marks an important milestone for Aprea. "We are committed to developing and
Kinases are enzymes that regulate essential cellular processes. The U.S. Food and Drug Administration's milestone approval in 2001 of the first kinase inhibitor, imatinib, was followed by a steady approval of kinase
The sBLA was submitted by Genmab's licensing partner, Janssen Biotech, Inc. in August 2016. Priority Review is an FDA designation for drugs that treat a serious condition and
The findings will be presented during a poster discussion session (Abstract #774PD) on October 9 at the European Society for Medical Oncology (ESMO) 2016 Congress, which is being
The agreement was reached through the Special Protocol Assessment (SPA) process. A SPA is an acknowledgement by FDA that the design and planned analysis of the Company's pivotal
The award will support research conducted during the Company's ongoing randomized, placebo-controlled Phase 2b proof-of-concept clinical study of SYN-004 (ribaxamase), designed to protect the gut microbiome from the
Kymo Therapeutics’s ambition is to move forward Metabrain Research’s proprietary program on kynurenine metabolism (KMO) inhibitors towards clinical proof of concept, before seeking partners to complete development and
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