Fierce BioTech

MAY 30, 2024

Quantify Cancer With Methylation-Based ctDNA Detection Download this resource to accelerate your oncology clinical trials, optimize patient enrollment, and monitor minimal residual disease and molecular response effectively.

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PPD

SEPTEMBER 25, 2023

As the clinical trial landscape evolves, drug developers are faced with novel challenges and changes in study recruitment, trial size and structure, and more. Decentralized Trials Digital and decentralized clinical trials  (DCTs) continue to expand and have become a standard solution for drug developers.

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The Pharma Data

OCTOBER 14, 2020

15, 2020 /PRNewswire/ — Thermo Fisher Scientific announced the launch of its Gibco CTS Rotea Counterflow Centrifugation System, a modular, closed cell therapy processing system that enables scalable, cost-effective cell therapy development and manufacturing. CARLSBAD, Calif. ,

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PPD

NOVEMBER 30, 2023

These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Overall, new technological approaches applied in these settings show remarkable potential to make trials more robust, promote more reliable data acquisition and keep trials on-time and on-budget. This year, the U.S.

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The Pharma Data

JANUARY 9, 2021

(NASDAQ: BMRN) today announced positive topline results from its ongoing global Phase 3 GENEr8-1 study of valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A. This is the largest global Phase 3 study to date for any gene therapy in any indication, with 134 participants.

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The Pharma Data

OCTOBER 16, 2020

As pharma companies search for solutions to avoid cancelling or delaying clinical trials, virtualizing trials are fast becoming commonplace during the Covid-19 pandemic. With many nationwide and regional lockdowns coming into force, virtual clinical trials are proving to be an effective way to monitor patients remotely.

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The Pharma Data

JANUARY 12, 2021

a biopharmaceutical company focused on the development of first-in-class therapeutics for the treatment of cancer, today announced the completion of the Phase 1b clinical trial conducted by the NCI with its lead clinical candidate zotiraciclib (ZTR/TG02), a potent oral cyclin-dependent kinase 9 (CDK9) inhibitor.

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The Pharma Data

NOVEMBER 15, 2020

16, 2020 /PRNewswire/ –: iSTAR Medical , a medtech company developing minimally invasive ophthalmic implants for treatment of patients with glaucoma, today announced positive one-year results from the European STAR-II clinical trial of its micro-invasive glaucoma surgery (MIGS) device, MINIject TM. WAVRE, Belgium , Nov.

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The Pharma Data

JANUARY 13, 2021

At Usona, Mr. Barrow was responsible for launching the Phase 2 clinical program for psilocybin in the treatment of Major Depressive Disorder and for obtaining Breakthrough Therapy Designation for the program at FDA. MindMed Co-CEO J.R. About MindMed.

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Plenge Gen

APRIL 7, 2020

You can download a pdf copy of the blog here.) Repurposing of approved therapies is the fastest way to impact patients today, as these medicines have regulatory approval to enable investigator-initiated trials and have a manufacturing process to ensure drug supply. The blog is long, so I will start with an executive summary.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) has cleared Armata’s IND to initiate a clinical trial of its lead therapeutic candidate, AP-PA02, in Pseudomonas aeruginosa infections. . View original content to download multimedia: [link]. “Results from this study, which we are calling SWARM- P.a.

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PPD

MARCH 26, 2024

These trends are driving a preference for the FSP model as more and more pharmaceutical companies look for ways to ensure successful trials in a highly competitive industry. PPD FSP solutions facilitate successful product development for partners, big and small, and help accelerate the next generation of life-changing therapies.

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The Pharma Data

JANUARY 31, 2021

Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax’s CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. EMERYVILLE, Calif. and CHENGDU, China , Feb.

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The Pharma Data

SEPTEMBER 17, 2020

17, 2020 /PRNewswire/ — Eli Lilly and Company (NYSE:LLY) and Amgen (NASDAQ:AMGN) today announced a global antibody manufacturing collaboration to significantly increase the supply capacity available for Lilly ‘s potential COVID-19 therapies. View original content to download multimedia: [link]. SOURCE Eli Lilly and Company.

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The Pharma Data

JANUARY 17, 2021

The results provide an opportunity for the company to pursue a pivotal Phase 2/3 clinical trial in patients with primary biliary cholangitis (PBC), based on interactions with the FDA. The trial consisted of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part with dosing up to 1600mg/day. About Genkyotex.

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PPD

SEPTEMBER 27, 2023

While some of the top pain points that companies named in 2022 have persisted, novel clinical trial approaches and emerging technologies have altered drug development companies’ predictions for the most influential industry trends. Applying artificial intelligence (AI) to drug development (e.g.,

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The Pharma Data

JANUARY 13, 2021

Fast Track designation is well-timed, as we anticipate starting our Phase 2 clinical trial in hospitalized COVID-19 patients this month, and should help bring Brilacidin to patients faster in these dire times.”. A preprint supporting Brilacidin’s COVID-19 treatment potential can be downloaded at the link below.

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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The Pharma Data

JANUARY 31, 2021

The practice offers standard and advanced therapeutics including chemotherapy, biologic therapy immunotherapies and radiopharmaceuticals along with a total complement of radiation oncology treatment options, including proton therapy, brachytherapy, and radiosurgery. View original content to download multimedia: [link].

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The Pharma Data

NOVEMBER 25, 2020

Under the agreement, which may generate revenue for BioInvent of up to SEK 30 million , BioInvent will provide process development, scale-up, supply of material for toxicological studies and clinical grade material in 1000L scale for use in phase I and II clinical trials. The Company’s validated, proprietary F.I.R.S.T

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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PPD

JUNE 17, 2024

With FSO, all clinical trial tasks (study startup, data management, clinical monitoring, pharmacovigilance, regulatory affairs, etc.) Increasingly, sponsors are looking for a hybrid approach that combines FSP and FSO models in a bespoke solution that maximizes clinical trial performance. are outsourced to the CRO.

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The Pharma Data

JANUARY 6, 2021

Quantitative imaging of CD8 T cells enables quicker identification of drug efficacy, therefore potentially reducing the length of clinical trials, reducing costs and helping new therapies to advance to market faster, which ultimately will improve treatment and care of cancer patients. About ImaginAb. ImaginAb Inc. Source link.

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The Pharma Data

OCTOBER 20, 2020

Local hospitals and universities will be able to both participate in on-going international trials and become the first research centers to initiate new clinical studies — potentially preceding trials with medical centers in Europe and the USA. View original content to download multimedia: [link]. SOURCE CureLab Oncology Inc.

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The Pharma Data

OCTOBER 19, 2020

With over 300 active clinical trials, Winship researchers are dedicated to taking new cancer treatments from bench to bedside. cancer centers selected as a Lead Academic Participating Site for the NCI’s National Clinical Trials Network (NCTN). Winship is one of 32 U.S. MBA, FACP, Chairman of the Caris Precision Oncology Alliance.

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The Pharma Data

JANUARY 10, 2021

Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE397, a small molecule methionine adenosyltransferase 2a (MAT2A) inhibitor, for the treatment of patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. View original content to download multimedia: [link].

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The Pharma Data

JANUARY 27, 2021

Based on these results, we will now move to identify the recommended Phase II dose for the Phase IIa part of the trial and look forward to further evaluating the exciting potential of BI-1206 to bring much needed innovation to lymphoma patients,” said Martin Welschof, Ph.D, (Nasdaq: CASI), a U.S. CEO of BioInvent.

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The Pharma Data

JANUARY 22, 2021

Voclosporin follows the recent approval of belimumab by the FDA as new therapies indicated for lupus nephritis – both within the past month. ” The approval of voclosporin is based on data taken from two positive pivotal trials — the AURORA Phase 3 study and the AURA-LV Phase 2 study. Available at: [link].

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The Pharma Data

DECEMBER 16, 2020

The Company will initiate its trial during the first quarter of 2021 to investigate the efficacy of Berubicin in adults with GBM who have failed first-line therapy. and 2 trials planned by our sublicensee WPD in Poland. . and 2 trials planned by our sublicensee WPD in Poland.

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The Pharma Data

DECEMBER 14, 2020

Many drugs fail in clinical trials because of their low blood brain barrier permeability. The effectiveness of standard therapy with TMZ is limited because the response of GBM to TMZ is dependent upon the expression of the DNA repair enzymatic protein, O 6 -alkylguanine DNA alkyltransferase (MGMT). Lantern’s A.I.

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KIF1A

AUGUST 28, 2024

KIF1A.ORG’s Chief Science Officer Dr. Dylan Verden will provide an overview of current areas of KAND therapeutic… Tuesday, September 24, 2024 5:00 pm – 6:00 pm Online via Zoom [link] ASO therapy: Positive Clinical Outcomes Observed We are thrilled to announce the publication of the **first-ever KAND ASO study** !

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The Pharma Data

NOVEMBER 15, 2020

Clover aims to double its commercial manufacturing capacity in preparation for global Phase 2/3 trials. The clinical trials and Clover’s COVID-19 vaccine program are supported by funding and collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI). SHANGHAI , Nov. About Cytiva.

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PPD

NOVEMBER 21, 2023

Clinical Development in the Biopharma and Biotech Arenas in 2023 Trial design approaches highlight differing priorities Thanks to the rapid development of novel cell and gene therapy approaches to treat cancer, oncology continues to dominate drug development pipelines.

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The Pharma Data

NOVEMBER 19, 2020

Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced that Andrew Robbins , Chief Executive Officer and President, will participate in a virtual fire side chat at the 3 rd Annual Evercore ISI HealthCONx Virtual Conference on Wednesday, December 2, 2020 at 10:55 a.m.

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The Pharma Data

JANUARY 31, 2021

Convergent has exclusive rights to technology related to next generation radiopharmaceutical therapy for prostate cancer that is covered by multiple issued U.S. The key component of Convergent’s PRRT prostate cancer therapy is its proprietary drug, CONV 01-?, and foreign patents. The function of CONV 01-?

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