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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.

CONNECT-FX study of Zygel fails to meet endpoints in Fragile X syndrome.- Zynerba Pharma

Written by | 1 Jul 2020

Zynerba Pharmaceuticals announced top line results from the 14-week pivotal CONNECT-FX study of Zygel (cannabidiol) which assessed its efficacy and safety as a treatment in for behavioral symptoms… read more.

Two phase I studies of INO 4800 report safety in COVID-19.- Inovio

Written by | 1 Jul 2020

Inovio has announced positive interim clinical data of INO 4800 vaccine candidate against novel coronavirus (SARS-CoV-2), from the first two Phase I clinical trial cohorts. In addition, INO… read more.

Ibsrela filed with FDA for hyperphosphatemia in adult patients with chronic kidney disease on dialysis.- Ardelyx

Written by | 1 Jul 2020

Ardelyx announced the submission of a New Drug Application (NDA) for Ibsrela (tenapanor) to the FDA for the control of serum phosphorus (hyperphosphatemia) in adult patients with chronic… read more.

EU approves Daurismo for acute myeloid leukemia.- Pfizer

Written by | 1 Jul 2020

Pfizer announced that the European Commission approved Daurismo (glasdegib), a Hedgehog pathway inhibitor, in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly… read more.

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