Human Trials

13 Dec 2019
- Clinical Trials
- Human Trials
Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin comparable to intravenous formulations in people with HER2-positive breast cancer

By PBR Staff Writer

Roche announced new data from the phase III FeDeriCa study which showed the investigational fixed-dose combination (FDC) of Perjeta (pertuzumab) and Herceptin (trastuzumab), administered by subcutaneous (SC) injection in combination with intravenous (IV) chemotherapy, demonstrated non-inferior levels of Perjeta in the blood (pharmacokinetics) and comparable efficacy and safety to standard IV infusions of Perjeta plus Herceptin and chemotherapy in eligible people with HER2-positive early breast cancer (eBC).
12 Dec 2019
$Fully-human BCMA CAR-T clinical results to treat relapsed/refractory multiple myeloma co-developed by IASO BIO and Innovent presented at 2019 ASH Annual Meeting$
Clinical Trials
Human Trials
Fully-human BCMA CAR-T clinical results to treat relapsed/refractory multiple myeloma co-developed by IASO BIO and Innovent presented at 2019 ASH Annual Meeting

By PBR Staff Writer

IASO Biotherapeutics, a clinical-stage biotechnology company advancing the development of innovative therapies for cancer, had the latest clinical data presented on their potential best-in-class therapy at the “Efficacy and Safety of Fully Human BCMA Targeting CAR T Cell Therapy in Relapsed Refractory Multiple Myeloma” session during the prestigious 61st Annual American Society of Hematology (ASH) Meeting & Exposition, December 7-10 in Orlando.
12 Dec 2019
Clinical Trials
Human Trials
Trastuzumab deruxtecan achieves tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial

By PBR Staff Writer

AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today presented positive detailed data from the global pivotal Phase II single-arm DESTINY-Breast01 trial of trastuzumab deruxtecan (DS-8201), a HER2-targeting antibody drug conjugate (ADC) and potential new medicine, in patients with HER2-positive metastatic breast cancer who received two or more prior HER2-targeted regimens.
12 Dec 2019
Clinical Trials
Human Trials
Leo Pharma’s tralokinumab meets key endpoints in phase 3 atopic dermatitis trials

By PBR Staff Writer

Danish medical dermatology firm Leo Pharma announced that its tralokinumab has achieved all primary and secondary endpoints in three phase 3 studies for the treatment of adults with moderate-to-severe atopic dermatitis (AD).
11 Dec 2019
Clinical Trials
Human Trials
Vedanta Biosciences initiates first-in-patient study of VE800 in combination with Bristol-Myers Squibb’s Opdivo

By PBR Staff Writer

Vedanta Biosciences announced the initiation of a first-in-patient clinical study of VE800 in combination with Bristol-Myers Squibb's programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab) in patients with select types of advanced or metastatic cancer.
10 Dec 2019
Clinical Trials
Human Trials
Novartis Kymriah demonstrates consistent efficacy and safety outcomes in US patients when used in real-world setting

By PBR Staff Writer

Novartis announced results from two analyses of real-world experience with Kymriah (tisagenlecleucel), the only CAR-T cell therapy approved in two distinct indications.
09 Dec 2019
$Kite’s Yescarta yields positive results in ZUMA-1 trial in refractory large B-cell lymphoma$
Clinical Trials
Human Trials
Kite’s Yescarta yields positive results in ZUMA-1 trial in refractory large B-cell lymphoma

By PBR Staff Writer

Kite, a Gilead Company announced new data from the ZUMA-1 trial of Yescarta (axicabtagene ciloleucel) in adult patients with refractory large B-cell lymphoma.
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).

Drug Discovery

Research & Development

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AGC Biologics to expand cell line development with ATUM partnership

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

Gerresheimer at CPHI Frankfurt 2025

Gerresheimer

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Human Trials

Roche’s fixed-dose subcutaneous combination of Perjeta and Herceptin comparable to intravenous formulations in people with HER2-positive breast cancer

Fully-human BCMA CAR-T clinical results to treat relapsed/refractory multiple myeloma co-developed by IASO BIO and Innovent presented at 2019 ASH Annual Meeting

Trastuzumab deruxtecan achieves tumour response rate of 60.9% in pivotal Phase II HER2-positive metastatic breast cancer trial

Leo Pharma’s tralokinumab meets key endpoints in phase 3 atopic dermatitis trials

Vedanta Biosciences initiates first-in-patient study of VE800 in combination with Bristol-Myers Squibb’s Opdivo

Novartis Kymriah demonstrates consistent efficacy and safety outcomes in US patients when used in real-world setting

Kite’s Yescarta yields positive results in ZUMA-1 trial in refractory large B-cell lymphoma

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

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Research & Development

Patient Enrollment

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