Human Trials

04 Nov 2020
- Clinical Trials
- Human Trials
Ionis and Akcea announce that Pfizer initiated clinical study of vupanorsen

By PBR Staff Writer

Ionis Pharmaceuticals and its wholly owned subsidiary Akcea Therapeutics, Inc., today announced that Pfizer has initiated a Phase 2b study of vupanorsen (AKCEA-ANGPTL3-LRx) in statin-treated patients with elevated non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides (TGs). The study, Targeting ANGPTL3 with an antisense oligonucleotide in adults with dyslipidemia (TRANSLATE-TIMI 70), will evaluate various doses of vupanorsen to inform potential future development.
04 Nov 2020
Clinical Trials
Human Trials
Bristol Myers Squibb’s deucravacitinib meets co-primary endpoints in psoriasis study

By PBR Staff Writer

Bristol Myers Squibb (BMS) announced that its deucravacitinib (BMS-986165) has achieved both co-primary endpoints in the phase 3 psoriasis study.
03 Nov 2020
Clinical Trials
Human Trials
Neuraly gets FDA clearance of INDA to initiate phase 2b trial of NLY01 in Alzheimer’s Disease

By PBR Staff Writer

Neuraly announced it has received clearance of an investigational new drug application (IND) to initiate a Phase 2B trial of NLY01 in patients with Alzheimer’s disease.
30 Oct 2020
Clinical Trials
Human Trials
Humanigen announces first patient dosed in NIH ACTIV-5/Big Effect trial evaluating lenzilumab for Covid-19

By PBR Staff Writer

Humanigen, a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ today announced that the first patient has been dosed at the Emory University School of Medicine in Atlanta, Georgia as part of the in the ACTIV-5 “Big Effect Trial” (ACTIV-5/BET) evaluating lenzilumab with remdesivir, compared to placebo and remdesivir, in patients hospitalized with COVID-19.
28 Oct 2020
Clinical Trials
Human Trials
Aurinia begins voclosporin trial in kidney transplant recipients with Covid-19

By PBR Staff Writer

Aurinia Pharmaceuticals has announced the commencement of an open-label exploratory trial to assess antiviral activity of voclosporin in kidney transplant recipients (KTRs) with Covid-19.
27 Oct 2020
Clinical Trials
Human Trials
ANA Therapeutics starts oral niclosamide trial for Covid-19 treatment

By PBR Staff Writer

Silicon Valley-based biotech start-up ANA Therapeutics has commenced a phase 2/3 clinical trial of oral niclosamide (ANA001) to treat the Covid-19 disease.
27 Oct 2020
Clinical Trials
Human Trials
HiFiBiO completes first cohort of phase 1 study of SARS-CoV-2 neutralising antibody

By PBR Staff Writer

HiFiBiO Therapeutics, a multinational biotherapeutics company with unique expertise in immune modulation and single-cell science, announced the successful completion of the first cohort of the Phase I study (NCT04590430) of HFB30132A, a SARS-CoV-2 neutralizing antibody for the treatment and prevention of COVID-19.
26 Oct 2020
Clinical Trials
Human Trials
FDA authorises restart of the COVID-19 AZD1222 vaccine US phase 3 trial

By PBR Staff Writer

Clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the US, UK, Brazil, South Africa and Japan confirming that it was safe to do so.
22 Oct 2020
Clinical Trials
Human Trials
Gilead announces new data on Biktarvy for the treatment of HIV in Black Americans

By PBR Staff Writer

Gilead Sciences announced 48-week data from the BRAAVE 2020 study, a Phase 3 clinical trial evaluating the safety and efficacy of switching to Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults living with HIV who self-identified as Black or African American.
20 Oct 2020
Clinical Trials
Human Trials
VelosBio announces first patient dosed in phase 2 trial of VLS-101 in solid tumours

By PBR Staff Writer

VelosBio announced that the first patient has been dosed in a Phase 2 trial of VLS-101 in patients with solid tumors. VLS-101, the company’s lead product candidate, is an antibody-drug conjugate (ADC) that targets ROR1.

Drug Discovery

Research & Development

FDA approves Eli Lilly’s Jaypirca in relapsed or refractory CLL/SLL

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

Ionis and Akcea announce that Pfizer initiated clinical study of vupanorsen

Bristol Myers Squibb’s deucravacitinib meets co-primary endpoints in psoriasis study

Neuraly gets FDA clearance of INDA to initiate phase 2b trial of NLY01 in Alzheimer’s Disease

Humanigen announces first patient dosed in NIH ACTIV-5/Big Effect trial evaluating lenzilumab for Covid-19

Aurinia begins voclosporin trial in kidney transplant recipients with Covid-19

ANA Therapeutics starts oral niclosamide trial for Covid-19 treatment

HiFiBiO completes first cohort of phase 1 study of SARS-CoV-2 neutralising antibody

FDA authorises restart of the COVID-19 AZD1222 vaccine US phase 3 trial

Gilead announces new data on Biktarvy for the treatment of HIV in Black Americans

VelosBio announces first patient dosed in phase 2 trial of VLS-101 in solid tumours

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