Oncology

Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

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What You Should Know: – Northwestern Memorial Hospital is the first in the nation to deploy FDA-cleared AI-guided ultrasound by Caption Health, including measurement of ejection fraction – the most widely used measurement to assess cardiac function. – Caption Health’s AI-guided cardiac ultrasound enables clinicians… Read More »Northwestern to Deploy FDA-Cleared Deploy AI-Guided Cardiac Ultrasounds

Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors

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Shots: The P-I dose-escalation study will assess the safety, tolerability, and preliminary efficacy of DS-1055 in adult patients with r/r advanced or metastatic head and neck, gastric and esophageal cancers, and other tumor types The focus of the study is to determine the maximum tolerated… Read More »Daiichi Sankyo Initiates P-I Study of DS-1055 for Relapsed/Refractory Advanced or Metastatic Solid Tumors

FDA kicks off review of second kidney cancer combo based on BMS’ Opdivo

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Bristol-Myers Squibb could be mere months away from claiming a second US approval for an Opdivo-based combination immunotherapy that will help defend its first-line kidney cancer franchise. The FDA has started a priority review of PD-1 inhibitor Opdivo (nivolumab) alongside Exelixis’ tyrosine kinase inhibitor Cabometyx… Read More »FDA kicks off review of second kidney cancer combo based on BMS’ Opdivo

Founders’ Story: Cancer Insights

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Cancer Insights co-founders, President and CEO Tarun Kumar and CIO Dr. Sharon Hensley Alford, discuss their company’s goals to transform the oncology care continuum.

Shock as FDA rejects Mesoblast’s Ryoncil in paediatric graft versus host disease

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The FDA has rejected Mesoblast’s Ryoncil cell therapy for children with graft versus host disease, despite a recommendation to approve from a panel of expert advisers. In August the FDA’s Oncology Drugs Advisory Committee voted nine to one in favour of approving Ryoncil (remestemcel-L), making… Read More »Shock as FDA rejects Mesoblast’s Ryoncil in paediatric graft versus host disease

TIGIT Therapies Digital Summit

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The TIGIT checkpoint has gained much attention in recent years due to the number of roles it plays in several malignancies. TIGIT’s diverse function in multiple cell types has made it a lucrative immunotherapy candidate, with an increasing number of candidates being investigated in pre-clinical and clinical… Read More »TIGIT Therapies Digital Summit

Novartis eyes filings for leukaemia drug asciminib after phase 3 win

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A first-in-class STAMP inhibitor developed by Novartis – asciminib – has outperformed a current drug for chronic myeloid leukaemia (CML) in a head-to-head trial, setting up regulatory filings. The ASCEMBL trial compared asciminib (ABL001) to Pfizer’s Bosulif (bosutinib) in Philadelphia chromosome-positive CML patients who had… Read More »Novartis eyes filings for leukaemia drug asciminib after phase 3 win

Sharing oncology trial PROs to build the treatment of the future

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Could collecting, understanding, and disseminating patient-reported outcomes during trials be the key to advancing oncology treatments and improving cancer outcomes?  With our understanding of cancer accelerating at an unprecedented rate, and personalised medicines on the cusp of becoming mainstream, regulatory bodies need new ways to… Read More »Sharing oncology trial PROs to build the treatment of the future

FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

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What You Should Know: The FDA and Syapse announce research collaboration expansion to address urgent public health challenges including supporting FDA’s goal of rapid understanding of COVID-19. As part of the research, Syapse is partnering with FDA’s Oncology Center of Excellence to investigate methods to… Read More »FDA, Syapse Expand Research to Generate Real-World Data Related to COVID-19 and Cancer

GSK nabs FDA approval for first-in-class multiple myeloma drug

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Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.

AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

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Shots: Daichii Sankyo to receive $1B as upfront of which $350M is due upon execution, $325M after 12mos. and $325M after 24 mos., ~$5B as contingent payment including $1B as regulatory milestones, and $4B as commercial milestones, making a total deal value up to ~6B… Read More »AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

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Shots: Sorrento enters into letter of intent to acquire SmartPharm and develops pipeline of gene-encoded therapeutic Ab, initiating with Sorrento’s STI-1499 or COVI-GUARD, currently preclinical studies with an IND submission targeted for Aug’2020. The transaction is expected to be close in Aug’2020. The integration of… Read More »Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

How to increase haematologists’ and oncologists’ confidence with new treatments

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A new whitepaper from Medscape highlights the difficulties haematologists and oncologists face in keeping up with rapid developments in treatment. We speak to the company’s Katie Lucero and Victoria Harvey-Jones to find out how independent medical education is changing to help HCPs increase their confidence… Read More »How to increase haematologists’ and oncologists’ confidence with new treatments

Merck KGaA takes second option from cancer immunotherapy pact with F-Star

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Germany’s Merck KGaA has taken an option on a second cancer immunotherapy drug from its development deal with Anglo-American biotech F-star Therapeutics.  The companies signed a deal to develop cancer immunotherapies in summer 2017, where Darmstadt-based Merck KGaA paid $115 million up front, agreeing to further payments during the first two years of… Read More »Merck KGaA takes second option from cancer immunotherapy pact with F-Star

NICE backs NHS use for Astellas’ Xospata after rethink

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NICE has recommended regular NHS funding for Astellas’ Xospata (gilteritinib) monotherapy for certain adult patients with acute myeloid leukaemia.  In final draft guidance NICE said that the drug is recommended for relapse or refractory FLT3 mutation-positive AML, giving patients an alternative to chemotherapy and its unpleasant side effects.  However because of… Read More »NICE backs NHS use for Astellas’ Xospata after rethink