Human Trials

09 Dec 2019
- Clinical Trials
- Human Trials
Calquence significantly prolonged time patients lived without disease progression or death in previously untreated CLL

By PBR Staff Writer

AstraZeneca presented results from the interim analysis of the Phase III ELEVATE TN trial, showing that Calquence (acalabrutinib) combined with obinutuzumab or as monotherapy significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, a standard chemo-immunotherapy treatment, in patients with previously untreated chronic lymphocytic leukaemia (CLL).
09 Dec 2019
Clinical Trials
Human Trials
Bristol-Myers Squibb’s Liso-Cel meets key endpoints in blood cancer trial

By PBR Staff Writer

Bristol-Myers Squibb announced that its blood cancer treatment lisocabtagene maraleucel (liso-cel) has achieved its primary and secondary endpoints in TRANSCEND NHL 001 study.
06 Dec 2019
Clinical Trials
Human Trials
FerGene’s phase 3 NMIBC study of Nadofaragene Firadenovec meets primary endpoint

By PBR Staff Writer

FerGene, a new gene therapy company formed by Ferring Pharmaceuticals and Blackstone Life Sciences, announced positive results from the pivotal Phase 3 clinical trial evaluating nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy, for the treatment of high-grade, Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC).
03 Dec 2019
Clinical Trials
Human Trials
Knopp Biosciences, University of Leicester release details of phase 2 trial of dexpramipexole in severe eosinophilic asthma

By PBR Staff Writer

Knopp Biosciences LLC and the University of Leicester have announced timelines, trial details, and eligibility criteria for a planned Phase 2 clinical trial evaluating the oral eosinophil-lowering drug candidate dexpramipexole in severe eosinophilic asthma patients that is on track to begin in the first half of 2020.
03 Dec 2019
Clinical Trials
Human Trials
Phathom Pharmaceuticals announces initiation of pivotal phase 3 clinical trial for vonoprazan in erosive esophagitis

By PBR Staff Writer

Phathom Pharmaceuticals, a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, announced today the initiation of PHALCON-EE, the Company’s pivotal Phase 3 clinical trial of vonoprazan for both the healing and maintenance of healing of erosive esophagitis (EE) as well as the relief of heartburn.
02 Dec 2019
Clinical Trials
Human Trials
Sensorion’s Seliforant to treat AUV fails to meet primary endpoint in phase 2b trial

By PBR Staff Writer

Sensorion’s SENS-111 (Seliforant) has failed to meet primary endpoint in the phase 2b proof-of-concept trial to treat acute unilateral vestibulopathy (AUV).
29 Nov 2019
Clinical Trials
Human Trials
Medincell receives $19m grant for mdc-WWM programme

By PBR Staff Writer

French company MedinCell (Paris:MEDCL) and the Bill & Melinda Gates Foundation have signed an agreement for up to an additional $19 million to be granted over four years.
26 Nov 2019
Clinical Trials
Human Trials
EpicentRx announces positive results from phase 1 trial of RRx-001 as first-line treatment in newly diagnosed glioblastoma

By PBR Staff Writer

EpicentRx, Inc., a clinical cancer immunotherapy company targeting both sides of the immune system to deliver cancer treatments with minimal toxicity, announced positive results from the Phase 1 G-FORCE trial of RRx-001 as first-line treatment in newly diagnosed glioblastoma
25 Nov 2019
Clinical Trials
Human Trials
Roche’s Tecentriq, Avastin combo improves OS in unresectable HCC

By PBR Staff Writer

Roche said that Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) improved the overall survival in a phase 3 trial in patients with unresectable hepatocellular carcinoma (HCC), the most common form of liver cancer.
20 Nov 2019
Clinical Trials
Human Trials
Sangamo announces UK authorisation of a phase 1/2 clinical trial evaluating the CAR-Treg cell therapy TX200 for kidney transplantation

By PBR Staff Writer

Sangamo Therapeutics, a genomic medicine company, announced today that the United Kingdom’s (UK) Medicines Healthcare Products Regulatory Agency (MHRA) has granted authorization of the first-in-human clinical trial to evaluate a Chimeric Antigen Receptor Regulatory T Cell (CAR-Treg) therapy.

Drug Discovery

Research & Development

Enthorin and Rumi sign agreement for FXS therapy

Astellas and AI Proteins sign miniprotein therapeutics deal

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

Formation Bio launches $600m drug development fund

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

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

Calquence significantly prolonged time patients lived without disease progression or death in previously untreated CLL

Bristol-Myers Squibb’s Liso-Cel meets key endpoints in blood cancer trial

FerGene’s phase 3 NMIBC study of Nadofaragene Firadenovec meets primary endpoint

Knopp Biosciences, University of Leicester release details of phase 2 trial of dexpramipexole in severe eosinophilic asthma

Phathom Pharmaceuticals announces initiation of pivotal phase 3 clinical trial for vonoprazan in erosive esophagitis

Sensorion’s Seliforant to treat AUV fails to meet primary endpoint in phase 2b trial

Medincell receives $19m grant for mdc-WWM programme

EpicentRx announces positive results from phase 1 trial of RRx-001 as first-line treatment in newly diagnosed glioblastoma

Roche’s Tecentriq, Avastin combo improves OS in unresectable HCC

Sangamo announces UK authorisation of a phase 1/2 clinical trial evaluating the CAR-Treg cell therapy TX200 for kidney transplantation

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Research & Development

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Drug Filing

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