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Sanofi's Sarclisa bags NICE recommendation
pharmatimes
October 19, 2020
French pharma Sanofi’s Sarclisa has been granted a positive recommendation from the National Institute for Health and Care (NICE) for patients with multiple myeloma.
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US FDA grants orphan drug designation to oNKord from Glycostem for multiple myeloma
expresspharma
October 14, 2020
The designation will provide Glycostem with eligibility for seven years of market exclusivity and clear FDA guidance on specific aspects of development for rare diseases.
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Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel for Adults with Relapsed and Refractory Multiple Myeloma
drugs.com
September 23, 2020
Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S.
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NICE turns down Celgene's Revlimid as multiple myeloma maintenance treatment
pharmatimes
September 23, 2020
The National Institute for Heath and Care Excellence (NICE) has turned down NHS funding of Celgene's Revlimid (lenalidomide) as maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults.
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SpringWorks, Janssen to Evaluate Nirogacestat with Teclistamab for Multiple Myeloma
americanpharmaceuticalreview
September 21, 2020
SpringWorks Therapeutics has entered into a clinical collaboration and supply agreement with Janssen Biotech to evaluate SpringWorks’ investigational gamma secretase inhibitor (GSI), nirogacestat, in combination with Janssen’s bispecific antibody ...
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Blenrep granted CMA for relapsed or refractory multiple myeloma
europeanpharmaceuticalreview
August 31, 2020
The European Commission granted the conditional marketing authorisation (CMA) based on data from a trial in which Blenrep achieved an overall response rate of 32 percent.
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GSK bags EU approval for Blenrep
pharmatimes
August 27, 2020
Hot on the heels of US approval GlaxoSmithKline has now also bagged a nod in Europe for Blenrep (belantamab mafodotin-blmf) as a treatment for patients with relapsed for refractory multiple myeloma (MM).
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KYPROLIS, DARZALEX Combo Approved for Multiple Myeloma
contractpharma
August 24, 2020
The study's primary endpoint resulted in a 37% reduction in the risk of disease progression or death.
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US expand use of Janssen's Darzalex
pharmatimes
August 21, 2020
US regulators have approved Janssen's Darzalex (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adults with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy.
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GSK gets USFDA approval for BLENREP to treat relapsed or refractory multiple myeloma
expresspharma
August 07, 2020
BLENREP is the fifth major medicine approval for GSK in 2020.