Paul Schloesser Associate Editor Clovis Oncology is facing yet another setback with the FDA giving the battled company a complete response letter and rejecting a potential label expansion for its PARP inhibitor Rubraca. A new SEC filing Friday detailed how it received the CRL from the FDA on May 26, rejecting an sNDA for Rubraca as a first-line maintenance treatment for women with advanced ovarian cancer who are in complete or partial response to a first-line, platinum-based chemotherapy. FDA said that for the agency to reconsider the application, per the filing, Clovis would need to show results from an overall survival analysis that “do not demonstrate a potential OS detriment.” In the meantime, Clovis said that the FDA’s determination would impact the timing and achievability of milestone payments that Clovis is owed. The company sold rights to its PARP inhibitor to Swiss company pharma& Schweiz GmbH in an April deal ...
Quest Diagnostics is boosting its capabilities in cancer, paying $300 million to acquire a Johns Hopkins University spinout whose technology identifies cancer cells in order to guide treatment decisions. The Secaucus, New Jersey-based diagnostics giant on Thursday announced the cash acquisition of Haystack Oncology. The Baltimore-based startup is part of a growing area in cancer testing called liquid biopsies, tests that detect cancer by finding circulating tumor DNA in a patient’s blood sample. Grail and Guardant Health are among the companies that market tests that detect early signs of cancer, enabling clinicians to intervene sooner. Haystack’s focus is minimal residual disease—detecting cancer cells that remain following initial treatment with surgery or a drug. Test results help clinicians assess how well the initial treatment worked and whether additional treatment, called an adjuvant, is necessary to kill any lingering cancer cells. That’s important because additional treatment, often a chemotherapy, introduces a wide ...
Digital technology company BullFrog AI and Sage Group have entered into a strategic partnership to develop oncology assets. This partnership will focus on exploring joint venture (JV) opportunities for advancing a Phase II ready asset and the preclinical prodrug asset of BullFrog AI. The Phase II ready asset targets glioblastoma, which is an aggressive form of brain cancer. Through the collaboration, BullFrog AI will gain access to Sage Group’s capital resources, clinical and regulatory expertise, as well as contacts network, including innovators and large pharma. BullFrog AI founder and CEO Vin Singh said: “Glioblastoma is one of the deadliest forms of cancer, with a five-year survival rate of less than seven percent. “With the Sage Group’s support, we look forward to identifying the right partner to help us advance clinical development of our oncology programs globally in an effort to bring a revolutionary new treatment option to glioblastoma patients.” Recently, ...
Caris Life Sciences and Flare Therapeutics have announced a partnership to advance the precision oncology pipeline of the latter into clinical trials. The multi-year strategic partnership will leverage latest molecular profiling approaches guiding patient selection and participation to accelerate precision medicine approaches across five of the therapeutic programmes of Flare. It will use the comprehensive molecular tissue and liquid profiling services of Caris including whole transcriptome sequencing and whole exome sequencing for participants in Flare’s clinical trials. Additionally, the partnership will apply Caris’ data and analytics tools to strengthen future enrolment programme for trials and companion diagnostics capabilities. Flare Therapeutics chief development officer Michaela Bowden said: “We understand the importance of shaping translational insights early on as a major area of focus to help ensure efficient drug development at scale and clinical trial preparedness. “With access to Caris’ robust clinico-genomic real-world data, comprehensive molecular profiling and ...
New collaboration to explore the potential clinical benefits of two novel and complementary immuno-oncology mechanisms
Sale of Oncology business unlocks embedded value within Shire`s portfolio and sharpens focus on core areas reinforcing our leadership in rare diseases
Illumina, Inc. (Nasdaq: ILMN) and Loxo Oncology (Nasdaq: LOXO) today announced a global strategic partnership to develop and commercialize a multi-gene panel for broad tumor profiling, resulting in a distributable, next-generation sequencing (NGS) based companion diagnostic (CDx) with a pan-cancer indication.
Pfizer and Allogene Therapeutics Enter into Asset Contribution Agreement for Pfizer’s Allogeneic CAR T Immuno-oncology Portfolio
BridgeBio Pharma today announced that it is has licensed infigratinib (BGJ398), a highly potent and selective inhibitor of the tyrosine kinase receptor FGFR, from Novartis. In addition, BridgeBio announced that it was launching new subsidiary QED Therapeutics to drive development of infigratinib with an initial financial commitment of $65 million.
Pfizer has collaborated with Foundation Medicine for the development of companion diagnostics (CDx) for its oncology portfolio.
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