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Phase III ODYSSEY HoFH trial of Praluent meets primary endpoint in homozygous familial hypercholesterolemia.- Regeneron Pharma

Written by | 1 Apr 2020

Regeneron Pharma has presented Phase III ODYSSEY HoFH trial results from a late-breaking presentation, demonstrating the effect of Praluent (alirocumab) in patients with homozygous familial hypercholesterolemia (HoFH). The… read more.

STRIDE-1 Phase III Trial of AXS 05 meets key secondary endpoints in depression.- Axsome Therapeutics

Written by | 1 Apr 2020

Axsome Therapeutics announced that AXS 05 (bupropion + dextromethorphan) met key secondary endpoints in the STRIDE-1 trial by rapidly and statistically significantly improving symptoms of depression on the… read more.

DAPA-CKD trial for Farxiga is stopped early in patients with chronic kidney disease due to overwhelming efficacy.- AstraZeneca

Written by | 1 Apr 2020

The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for Farxiga (dapagliflozin) in patients with chronic kidney disease (CKD) will be stopped… read more.

EU approves Nubeqa for castration-resistant prostate cancer .- Orion + Bayer

Written by | 1 Apr 2020

The European Commission has granted marketing authorisation in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), from Orion Corporation and Bayer. The approval… read more.

Phase III VICTORIA study of BAY 1021189 shows reduced risk of hospitalisation or death in heart failure.- Merck Inc + Bayer Healthcare

Written by | 31 Mar 2020

Merck Inc announced the presentation of results from the VICTORIA trial, a Phase III study evaluating the efficacy and safety of its investigational drug BAY 1021189 (vericiguat), an… read more.

Farxiga phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease.-AstraZeneca

Written by | 31 Mar 2020

The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for Farxiga (dapagliflozin) in patients with chronic kidney disease (CKD) will be stopped… read more.

FDA approves Imfinzi as first line treatment for extensive stage small cell lung cancer.- AstraZeneca

Written by | 31 Mar 2020

Imfinzi (durvalumab) from AstraZeneca has been approved in the US as a 1st-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with standard-of-care… read more.

CHMP recommends extending indication of Ruconest to children with Hereditary Angioedema.- Pharming

Written by | 31 Mar 2020

Pharming has announced the Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an… read more.

Sanofi receives positive CHMP opinion for Sarclisa for the treatment of relapsed and refractory multiple myeloma.

Written by | 29 Mar 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa (isatuximab). The CHMP recommends Sarclisa in combination with pomalidomide… read more.

CHMP recommends Cosentyx for the treatment of adult patients with active non-radiographic axial spondyloarthritis. -Novartis

Written by | 29 Mar 2020

Novartis, announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx (secukinumab) for the treatment… read more.

China’s National Medical Products Administration has accepted an application for the approval of denosumab copy biological HLX 14.- Shanghai Henlius Biotech

Written by | 29 Mar 2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of denosumab copy biological HLX 14. China-based… read more.

CHMP recommends Zolgensma for the treatment of patients with 5q spinal muscular atrophy . – Novartis

Written by | 29 Mar 2020

AveXis, a Novartis company, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending conditional… read more.

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