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ViiV Healthcare presents positive data from first-ever implementation research study on how best to integrate an investigational once-monthly injectable HIV treatment in US healthcare practices.

Written by | 7 Jul 2020

ViiV Healthcare, announced positive initial findings from the CUSTOMIZE trial (Cabotegravir plus Rilpivirine in the US To Optimize and Measure Implementation and Experience) which aims to identify successful… read more.

Cardiovascular and renal safety profile of linagliptin demonstrated in Asian adults with type 2 diabetes,- Boehringer + Eli Lilly

Written by | 5 Jul 2020

Boehringer Ingelheim have announced the results of a sub-group analysis from the CAROLINA cardiovascular outcome trial focusing on Asian adults with type 2 diabetes mellitus and elevated cardiovascular… read more.

European Commission approves Veklury a treatment for COVID-19 infection.- Gilead Sciences

Written by | 5 Jul 2020

Gilead Sciences, Inc.announced that the European Commission has granted conditional marketing authorization for Veklury (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19. The conditional… read more.

FDA approves Byfavo for procedural sedation in adults.- Acacia Pharma

Written by | 4 Jul 2020

Acacia Pharma announced that the FDA has approved Byfavo (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or… read more.

NHS to reimburse Kaftrio triple therapy to treat cystic fibrosis. – Vertex.

Written by | 4 Jul 2020

Vertex Pharmaceuticals Incorporated announced that it has expanded its reimbursement agreement with NHS England for Vertex’s cystic fibrosis medicines to include Kaftrio (ivacaftor/tezacaftor/elexacaftor), in a combination regimen with… read more.

Favourable topline results reported from innovaTV 204 trial of tisotumab vedotin for cervical cancer.- Seattle Genetics + Genmab AS

Written by | 3 Jul 2020

Genmab announced very favorable topline results from the Phase II single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of… read more.

Kevzara phase III U.S. trial in COVID-19 patients does not meet endpoints. Sanofi + Regeneron

Written by | 3 Jul 2020

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the . Phase III trial of Kevzara (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary… read more.

Phase III trial of SB 393 plus Vidaza in acute myeloid leukaemia discontinued.- Helsinn + MEI Pharma

Written by | 3 Jul 2020

Helsinn and MEI Pharma have discontinued a Phase III trial of SB 393 (pracinostat) in combination with Vidaza (azacitidine) in patients with acute myeloid leukaemia (AML) who are… read more.

Udenafil filed with FDA for single ventricle heart disease.- Mezzion Pharma

Written by | 3 Jul 2020

Mezzion Pharma has submitted a New Drug Application (NDA) to the FDA for udenafil to improve the physiology of patients aged at least 12 years with single ventricle… read more.

Preliminary data shows that BNT 162b1 is safe and immunologically active in COVID-19.- Pfizer and BioNTech

Written by | 2 Jul 2020

Pfizer and BioNTech announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT 162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2. The BNT… read more.

RM 493 filed with MAA for pro-opiomelanocortin (POMC) deficiency obesity and leptin receptor (LEPR) deficiency obesity.- Rhythm Pharma

Written by | 2 Jul 2020

Rhythm Pharmaceuticals announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for RM 493 (setmelanotide) for the treatment of pro-opiomelanocortin (POMC)… read more.

scPharmaceuticals Inc. has resubmitted its NDA to the FDA for Furoscix for the treatment of congestion in patients with heart failure.

Written by | 2 Jul 2020

scPharmaceuticals Inc. announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) to the FDA seeking approval of Furoscix (subcutaneous furosemide) for the treatment of congestion in… read more.

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