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Topline data for Libtayo to treat advanced basal cell carcinoma.- Sanofi + Regeneron

Written by | 5 May 2020

Topline data for a pivotal, single-arm, open-label trial for Sanofi and Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced basal cell carcinoma (BCC) who had progressed on… read more.

University of Louisville Division of Infectious Diseases Group B Streptococcus infections Study results announced by Pfizer.

Written by | 5 May 2020

Pfizer Inc. announced detailed results of the first study to show the burden of both invasive and non-invasive Group B Streptococcus infections (GBS) among hospitalized adults in the… read more.

FDA grants Emergency Use Authorization for its Elecsys Anti-SARS-CoV-2 antibody test which is also available in markets accepting the CE mark.

Written by | 5 May 2020

Roche announced that the FDA has issued an Emergency Use Authorization (EUA) for its new Elecsys Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a… read more.

CHMP recommends approval of Cabazitaxel Accord for metastatic prostate cancer.- Accord Healthcare

Written by | 4 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Cabazitaxel Accord (cabazitaxel), from… read more.

FDA grants emergency use authorization of remdesivir to treat COVID-19.

Written by | 3 May 2020

Gilead Sciences, Inc. announced that the FDA has granted emergency use authorization (EUA) for the investigational antiviral remdesivir to treat COVID-19. The EUA will facilitate broader use of… read more.

Rolling submission at EMA for remdesivir to treat coronavirus disease.- Gilead Sciences

Written by | 3 May 2020

EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19)…. read more.

Ayvakit fails to meet primary endpoint in Phase III VOYAGER trial versus regorafenib for gastrointestinal stromal tumor.- Blueprint Medicines Corpn.

Written by | 3 May 2020

Blueprint Medicines Corporation , a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, announced top-line results from the Phase III VOYAGER clinical trial… read more.

CHMP recommends Braftovi + cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation.- Pierre Fabre

Written by | 3 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Braftovi…. read more.

CC-486 has NDA accepted by FDA for maintenance treatment of adult patients in remission with acute myeloid leukemia.- BMS

Written by | 2 May 2020

Bristol Myers Squibb announced that the FDA has accepted its New Drug Application (NDA) for CC 486, an investigational oral hypomethylating agent, for the maintenance treatment of adult… read more.

CHMP recommends Insulin aspart Sanofi, a biosimilar product, intended for the treatment of diabetes mellitus.- Sanofi

Written by | 2 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Insulin aspart Sanofi, intended… read more.

CHMP recommends Daurismo intended for the treatment of acute myeloid leukaemia .- Pfizer

Written by | 2 May 2020

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Daurismo intended for the… read more.

CHMP recommends approval of Ultomiris for atypical hemolytic uremic syndrome.- Alexion Pharma

Written by | 2 May 2020

Alexion Pharmaceuticals announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending marketing authorization in the European Union for Ultomiris (ravulizumab) for… read more.

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