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EMA validates MAA for both idecabtagene vicleucel (ide-cel, bb2121) for multiple myeloma and CC 486 for the maintenance treatment of patients with acute myeloid leukemia (AML).- BMS + bluebird bio Inc.

Written by | 23 May 2020

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Applications (MAA) for both idecabtagene vicleucel (ide-cel, bb2121) and CC 486. Validation of… read more.

Abbott announces contract to supply millions of IgG Lab-Based antibody tests to the UK Government.

Written by | 23 May 2020

Abbott has announced a government contract to supply millions of its laboratory-based IgG antibody tests to National Health Service (NHS) laboratories across the UK over the coming months…. read more.

EU gives CE mark approval for UltraGene Combo2Screen SARS-CoV-2 assay as a diagnostic for COVID-19.- Advanced Biological Laboratories

Written by | 23 May 2020

Advanced Biological Laboratories (ABL) announced the CE-IVD registration of its UltraGene Combo2Screen SARS-CoV-2 assay, now available for in-vitro diagnostics use. This test is intended to be used for… read more.

ARCHITECT SARS-CoV-2 IgG test is authorized by Health Canada- Abbott

Written by | 23 May 2020

Abbott announced it received Health Canada authorization under the COVID-19 Interim Order for the ARCHITECT SARS-CoV-2 IgG test, a laboratory-based serology blood test for the detection of the… read more.

EMA accepts MAA for for roxadustat for the treatment of anemia in adult patients with chronic kidney disease.- Astellas + Fibrogen Inc.

Written by | 22 May 2020

Astellas Pharma Inc. and FibroGen, Inc. announced the marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with chronic kidney disease (CKD) has… read more.

EMA validates MAA for tafasitamab + lenalidomide to treat relapsed or refractory diffuse large B-cell lymphoma . Incyte + Morphosys AG

Written by | 22 May 2020

Incyte and MorphoSys AG announced the validation of the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with… read more.

JNJ 4528 showed early, deep and durable responses in heavily pretreated patients with multiple myeloma.Janssen Pharmaceutical Companies.

Written by | 21 May 2020

The Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1b/II CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ 4528, an investigational… read more.

Data from a Phase III trial of cabotegravir for HIV prevention has been stopped early because of high efficacy .- Viiv Health Care

Written by | 21 May 2020

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders announced the interim analysis of the HIV Prevention Trials… read more.

Results of phase IIb/III trial of filgotinib in moderately to severely active ulcerative colitis. Gilead Sciences + Galapagos NV

Written by | 21 May 2020

Gilead Sciences, Inc. and Galapagos NV announced positive topline results from SELECTION, a randomized, double-blind, placebo-controlled, Phase IIb/III trial evaluating the efficacy and safety of the investigational, oral,… read more.

Health Canada approves Rozlytrek for ROS1-positive non-small cell lung cancer.- Roche Canada

Written by | 21 May 2020

Roche Canada announced that Health Canada has granted market authorization to Rozlytrek (entrectinib) for the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer… read more.

FDA approves Lynparza to treat HRR gene-mutated metastatic castration-resistant prostate cancer. AstraZeneca + Merck Inc.,

Written by | 21 May 2020

AstraZeneca and MSD Inc.,have announced that Lynparza (olaparib) has been approved in the US for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The… read more.

Agios announces publication of Tibsovo phase III data in The Lancet Oncology demonstrating significant improvement in progression-free survival in previously treated IDH1-mutant cholangiocarcinoma patients.

Written by | 20 May 2020

Agios Pharmaceuticals, Inc. announced that The Lancet Oncology has published data from its global Phase III ClarIDHy study of Tibsovo (ivosidenib) in previously treated cholangiocarcinoma patients with an… read more.

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