Across

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Shots: The company presented the new data of its T-cell engaging bispecific Abs, mosunetuzumab, glofitamab and cevostamab at ASH 2020, demonstrating encouraging activity across multiple types of blood cancer Roche divulges that its mosunetuzumab & glofitamab showed promising responses across multiple types of NHL, including R/R FL & DLBCL, reinforcing from the P-I/Ib GO29781 study …

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Foundation Medicine’s FoundationOne CDx Receives the US FDA’s Approval as a CDx for Vitrakvi (larotrectinib)

Shots: The US FDA approved FoundationOneCDx to be used as a CDx for Vitrakvi (larotrectinib) to identify patients with NTRK fusions across all solid tumors. The genomic test is currently approved as a CDx for 20+ therapies The FoundationOne CDx is the tissue-based CGP test approved to detect NTRK1/2/3 fusions across all solid tumor types …

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Bayer and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas

Shots: The two partners will jointly enhance the existing platform utilizing One Drop’s know-how and capabilities of the One Drop platform and will co-develop digital health therapies across multiple therapeutic areas                One Drop will receive $98M financing, development fees and commercial milestones while in exchange Bayer will receive royalties on sales. In the future, Bayer …

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Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Shots: The US FDA has accepted the sBLA for a new self-administration option for Xolair across all approved indications in the US. The company anticipates the approval of the therapy in Q1’21 The acceptance is based on the efficacy and safety profile of Xolair in allergic asthma and chronic idiopathic urticaria (CIA) If approved, Xolair’s …

Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications Read More »