Human Trials

02 Apr 2020
- Clinical Trials
- Human Trials
BeiGene doses first patient in phase 1b/2 trial of ZW25 in HER2-positive breast cancer and GEA

By PBR Staff Writer

Zymeworks announced that its partner, BeiGene has dosed the first patient in a two-arm Phase 1b/2 trial evaluating the former's HER2-targeted bispecific antibody ZW25 in combination with chemotherapy as a first-line treatment for patients with metastatic HER2-positive breast cancer and in combination with chemotherapy and BeiGene’s PD-1-targeted antibody tislelizumab as a first-line treatment for patients with metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).
02 Apr 2020
Clinical Trials
Human Trials
Concert Pharmaceuticals announces plans for CTP-543 phase 3 trials in alopecia areata

By PBR Staff Writer

Concert Pharmaceuticals announced the details of its pivotal Phase 3 trials of CTP-543 in patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss.
31 Mar 2020
Clinical Trials
Human Trials
Noveome to assess ST266 to treat severe inflammatory response linked with COVID-19

By PBR Staff Writer

Noveome Biotherapeutics has launched a new programme to assess its ST26 product candidate for the treatment of the severe inflammatory cytokine storm response associated with COVID-19, the disease resulted due to the novel coronavirus SARS-CoV-2.
30 Mar 2020
Clinical Trials
Human Trials
Merck’s vericiguat meets primary endpoint in VICTORIA trial

By PBR Staff Writer

Merck said that its orally administered soluble guanylate cyclase (sGC) stimulator vericiguat met the primary efficacy endpoint in the phase 3 VICTORIA trial in heart failure patients.
30 Mar 2020
Clinical Trials
Human Trials
AVEO Oncology and Biodesix to discontinue CyFi-2 study of ficlatuzumab in AML in response to public health crisis

By PBR Staff Writer

AVEO Oncology and Biodesix announced the discontinuation of their CyFi-2 study, a randomized Phase 2 clinical study evaluating ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with high-dose cytarabine vs. high-dose cytarabine alone in patients with relapsed and refractory acute myeloid leukemia (AML).
25 Mar 2020
Clinical Trials
Human Trials
AveXis’ Zolgensma gene therapy yields desired results in SMA trials

By PBR Staff Writer

AveXis said that a one-time infusion of Zolgensma (onasemnogene abeparvovec-xioi) delivered rapid, substantial, and clinically meaningful therapeutic benefit in spinal muscular atrophy (SMA) patients across a range of trials.
24 Mar 2020
Clinical Trials
Human Trials
AbbVie announces positive topline results from phase 3 trial of VENCLEXTA, Azacitidine combo in AML

By PBR Staff Writer

AbbVie announced the VIALE-A (M15-656) trial of VENCLEXTA (venetoclax) in combination with azacitidine versus azacitidine in combination with placebo met its dual primary endpoints of statistically significant improvement of overall survival (OS) and composite complete remission rate (CR + CRi) for patients with previously-untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
24 Mar 2020
Clinical Trials
Human Trials
FDA approves COVACTA trial for RA drug Actemra in COVID-19 patients

By PBR Staff Writer

Genentech has secured approval in the US to go ahead with the COVACTA trial to assess the use of its rheumatoid arthritis drug (RA drug) Actemra (tocilizumab) in COVID-19 patients.
23 Mar 2020
Clinical Trials
Human Trials
Feinstein Institutes begins three clinical trials for COVID-19 patients

By PBR Staff Writer

Northwell Health’s Feinstein Institutes for Medical Research has announced the recruitment of patients in three clinical studies, which are designed to eliminate the COVID-19 novel coronavirus.
20 Mar 2020
Clinical Trials
Human Trials
Roche to begin Actemra/RoActemra trial with COVID-19 pneumonia patients

By PBR Staff Writer

Roche has announced that it will begin a phase III clinical trial of Actemra/RoActemra (tocilizumab) in hospitalised patients with severe COVID-19 pneumonia.

Drug Discovery

Research & Development

Superluminal Medicines secures $60m to advance rare obesity therapy

Takeda and Weave Bio collaborate on AI-driven automation in drug development

Clinical Trials

Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

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

Regulation

Drug Filing

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

Scholar Rock submits application of SMA therapy to FDA

Production & Sales

Manufacturing

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

Suppliers

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Human Trials

BeiGene doses first patient in phase 1b/2 trial of ZW25 in HER2-positive breast cancer and GEA

Concert Pharmaceuticals announces plans for CTP-543 phase 3 trials in alopecia areata

Noveome to assess ST266 to treat severe inflammatory response linked with COVID-19

Merck’s vericiguat meets primary endpoint in VICTORIA trial

AVEO Oncology and Biodesix to discontinue CyFi-2 study of ficlatuzumab in AML in response to public health crisis

AveXis’ Zolgensma gene therapy yields desired results in SMA trials

AbbVie announces positive topline results from phase 3 trial of VENCLEXTA, Azacitidine combo in AML

FDA approves COVACTA trial for RA drug Actemra in COVID-19 patients

Feinstein Institutes begins three clinical trials for COVID-19 patients

Roche to begin Actemra/RoActemra trial with COVID-19 pneumonia patients

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Research & Development

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