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Keytruda is now approved for adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) mutations/megabase] solid tumors.- Merck inc.

Written by | 19 Jun 2020

Merck Inc., announced that the FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational… read more.

Low-cost dexamethasone reduces death by up to one third in hospitalised patients with severe respiratory complications of COVID-19.- Generic

Written by | 18 Jun 2020

In March 2020, the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19, including… read more.

Additional data from 4 year update of ongoing phase 1/II study of valoctocogene roxaparvovec gene therapy for severe hemophilia A presented at World Federation of Hemophilia virtual summit.- BioMarin

Written by | 18 Jun 2020

BioMarin Pharmaceutical Inc. announced additional data from its previously reported four-year update of an open-label Phase 1/II study of valoctocogene roxaparvovec , an investigational gene therapy treatment for… read more.

Phase III LINC-4 study of Isturisa for the treatment of patients with Cushing’s disease.- Recordati

Written by | 18 Jun 2020

Recordati announces positive results from the large Phase III LINC-4 study of Isturisa (osilodrostat) for the treatment of patients with Cushing’s disease for whom pituitary surgery is not… read more.

Phase III VERTIS CV trial with Steglatro meets endpoint in type 2 diabetes + CV.- Merck Inc and Pfizer

Written by | 17 Jun 2020

Merck Inc and Pfizer announced the presentation of results from the Phase III VERTIS CV cardiovascular (CV) outcomes trial that evaluated Steglatro (ertugliflozin), an oral sodium-glucose cotransporter 2… read more.

FDA approves Lyumjev (insulin lispro-aabc injection), a new rapid-acting insulin.- Eli Lilly

Written by | 17 Jun 2020

The FDA has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company’s new rapid-acting insulin indicated to improve glycemic control in adults with… read more.

FDA approves Cosentyx to treat active non-radiographic axial spondyloarthritis.- Novartis

Written by | 17 Jun 2020

Novartis, announced that the FDA has approved Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis (axSpA) disease… read more.

FDA approves Semglee an insulin glargine injection biosimilar for types 1 and 2 diabetes.- Mylan + Biocon

Written by | 16 Jun 2020

Mylan N.V. and Biocon Ltd. announced that the FDA has approved the New Drug Application (NDA) for Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to… read more.

Phase III BEST trial of THR 1442 shows efficacy in type 2 diabetes with CV risk.- Theracos

Written by | 15 Jun 2020

Phase III BEST trial data shows that THR 1442 (bexagliflozin) from Theracos, lowers weight, blood pressure and glycated haemoglobin (HbA1c) relative to placebo in patients with type 2… read more.

Results from phase II ACE-CL-001 trial and Phase III ASCEND trials shows long-term efficacy of Calquence in chronic lymphocytic leukaemia.- AstraZeneca

Written by | 15 Jun 2020

Detailed results from both the Phase II ACE-CL-001 trial and the pivotal Phase III ASCEND trial showed the long-term efficacy and tolerability of Calquence (acalabrutinib), from AstraZeneca, in… read more.

Zealand Pharma presents clinical and non-clinical evidence for dasiglucagon rescue therapy at the 80th Scientific Sessions of the American Diabetes Association.

Written by | 15 Jun 2020

Zealand Pharma A/S presented elaborated results from two Phase III clinical studies with dasiglucagon as treatment for severe hypoglycemia as well as one preclinical PK/PD study investigating aqueous… read more.

Phase III study of subcutaneous daratumumab combination treatment shows positive response in light chain (AL) amyloidosis.- Janssen R&D

Written by | 14 Jun 2020

The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from the first randomized Phase III study investigating subcutaneous Darzalex (daratumumab) in the treatment of patients with newly… read more.

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