Human Trials

08 Jul 2019
- Clinical Trials
- Human Trials
Ipsen, Servier announce initial phase 1/2 data of liposomal irinotecan in metastatic pancreatic cancer

By PBR Staff Writer

Ipsen and Servier announced preliminary data from the Phase 1/2 study of the investigational use of liposomal irinotecan (ONIVYDE) in combination with 5- fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) in study patients with previously untreated metastatic pancreatic ductal adenocarcinoma cancer (PDAC) at the ESMO 21st World Congress on Gastrointestinal Cancer in Barcelona, Spain, 3–6 July 2019.
08 Jul 2019
Clinical Trials
Human Trials
BiondVax enrols first patient in phase 3 second cohort of M-001 flu vaccine

By PBR Staff Writer

BiondVax Pharmaceuticals said that it has enrolled the first participant in the second cohort of a phase 3 trial of its M-001 universal flu vaccine candidate.
08 Jul 2019
Clinical Trials
Human Trials
Pfizer, Sangamo’s gene therapy show promise in phase 1/2 hemophilia A study

By PBR Staff Writer

Pfizer and Sangamo Therapeutics have announced that an investigational SB-525 hemophilia A gene therapy has showed a sustained increased factor VIII (FVIII) levels in phase 1/2 Alta study.
05 Jul 2019
Clinical Trials
Human Trials
VALBIOTIS announces positive results from phase IIA trial of VALEDIA in prediabetics

By PBR Staff Writer

VALBIOTIS announced positive results (topline data) for the Phase IIA study of VALEDIA (active substance: TOTUM-63), which evaluated this product's efficacy in a prediabetic population, compared to placebo.
05 Jul 2019
Clinical Trials
Human Trials
Cantargia announces full recruitment of CAN04 monotherapy arm in ongoing phase IIa clinical trial

By PBR Staff Writer

Cantargia´s antibody CAN04 (nidanilimab) is investigated in an open label three-armed phase IIa clinical trial, CANFOUR.
04 Jul 2019
Clinical Trials
Human Trials
GSK begins phase 3 trial for otilimab in patients with rheumatoid arthritis

By vbandhakavi

GSK today announced the start of a phase III clinical development programme with otilimab, an investigational anti-granulocyte macrophage colony-stimulating factor (anti GM-CSF) monoclonal antibody, for patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to disease modifying antirheumatic drugs (DMARD) or targeted therapies.
03 Jul 2019
Clinical Trials
Human Trials
Roche’s flu drug Xofluza meets primary endpoint in phase III children study

By PBR Staff Writer

Roche’s flu drug Xofluza (baloxavir marboxil) has achieved primary endpoint in phase III Ministone-2 children study.
03 Jul 2019
Clinical Trials
Human Trials
Dicerna to begin clinical development of DCR-A1AT for A1AT deficiency-associated liver disease

By PBR Staff Writer

Dicerna Pharmaceuticals has submitted a Clinical Trial Authorization (CTA) application to the Swedish Medical Products Agency (MPA) last week to conduct a first-in-human Phase 1/2 study of DCR-A1AT, an investigational therapy from the Company’s GalXC technology platform, for the treatment of alpha-1 antitrypsin (A1AT) deficiency-associated liver disease.
02 Jul 2019
Clinical Trials
Human Trials
Vedanta Biosciences enrols first patient in VE416 phase 1b/2 food allergy clinical study

By PBR Staff Writer

Vedanta Biosciences announced the first patient has been enrolled in the Phase 1b/2 clinical study of VE416 in adults and adolescents with a history of peanut allergy.
28 Jun 2019
Clinical Trials
Human Trials
Xeris doses first patient in phase 2 trial of developmental ready-to-use glucagon in PBH

By PBR Staff Writer

Xeris Pharmaceuticals has dosed the first subject in a Phase 2 trial with its developmental ready-to-use glucagon in patients who experience hypoglycemic episodes following bariatric surgery.

Drug Discovery

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US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

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Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

Production & Sales

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ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Merck introduces single-use reactor to accelerate ADC manufacturing

Packaging & Supply Chain

Packaging

Uwe Röhrhoff Steps Down as Interim CEO of Gerresheimer AG

Gerresheimer at CPHI Frankfurt 2025

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Human Trials

Ipsen, Servier announce initial phase 1/2 data of liposomal irinotecan in metastatic pancreatic cancer

BiondVax enrols first patient in phase 3 second cohort of M-001 flu vaccine

Pfizer, Sangamo’s gene therapy show promise in phase 1/2 hemophilia A study

VALBIOTIS announces positive results from phase IIA trial of VALEDIA in prediabetics

Cantargia announces full recruitment of CAN04 monotherapy arm in ongoing phase IIa clinical trial

GSK begins phase 3 trial for otilimab in patients with rheumatoid arthritis

Roche’s flu drug Xofluza meets primary endpoint in phase III children study

Dicerna to begin clinical development of DCR-A1AT for A1AT deficiency-associated liver disease

Vedanta Biosciences enrols first patient in VE416 phase 1b/2 food allergy clinical study

Xeris doses first patient in phase 2 trial of developmental ready-to-use glucagon in PBH

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