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Phase III clinical data of Fexuprazan shows efficacy in gastroesophageal reflux disease.- Daewoong Pharma

Written by | 9 May 2020

Daewoong Pharmaceutical unveiled for the first time the phase III clinical data of Fexuprazan, a novel gastroesophageal reflux disease agent at Digestive Disease Week (DDW) 2020. The phase… read more.

Rebiotix + Ferring announce first with positive preliminary pivotal phase III data for investigational microbiome-based therapy RBX2660.

Written by | 8 May 2020

Rebiotix and Ferring Pharmaceuticals announced positive preliminary findings from their ongoing pivotal Phase III trial of the investigational microbiome-based treatment, RBX 2660. These preliminary positive efficacy findings mark… read more.

Positive topline results from the UNITY-CLL phase III study of the combination of umbralisib and ublituximab (U2) for the treatment of chronic lymphocytic leukemia.- TG Therapeutics

Written by | 8 May 2020

TG Therapeutics, Inc.has announced positive topline results from the global UNITY-CLL Phase III trial evaluating the combination of umbralisib plus ublituximab (U2) compared to obinutuzumab plus chlorambucil in… read more.

Health Canada approves Real-Time Fluorescent RT-PCR Kit for detecting SARS-CoV-2.- BGI Genomics

Written by | 8 May 2020

BGI Genomics announced that its subsidiary BGI Americas Corporation has received authorization under Interim Order from Health Canada to supply its Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2… read more.

TAVO + Keytruda demonstrated 41% overall response rate and 36% complete response in a late-stage metastatic melanoma study featured in ‘Clinical Cancer Research’.- Oncosec Medical.

Written by | 8 May 2020

Oncosec Medical announced published data in Clinical Cancer Research that demonstrated its lead product candidate, TAVO (interleukin-12 or “IL-12” plasmid), in combination with the anti-PD-1 checkpoint inhibitor Keytruda… read more.

FDA extends PDUFA date for liso-cel to treat large B-cell lymphoma. – BMS

Written by | 7 May 2020

Bristol Myers Squibb announced that the FDA has extended the action date by three months for the biologics license application (BLA) for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric… read more.

First participants dosed in phase I/II trial of BNT 162 vaccine to prevent COVID-19. Pfizer + BioNTech SE

Written by | 7 May 2020

Pfizer Inc. and BioNTech SE announced that the first participants have been dosed in the U.S. in the Phase 1/II clinical trial for the BNT 162 vaccine program… read more.

INNO2VATE phase III program of AKB 6548 meets primary and secondary endpoints in anaemia due to chronic kidney disease.- Akebia Therapeutics

Written by | 6 May 2020

Akebia Therapeutics announced positive top-line results from INNO2VATE, its global Phase III cardiovascular outcomes program evaluating the efficacy and safety of AKB 6548 (vadadustat), its investigational oral hypoxia-inducible… read more.

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.

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