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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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

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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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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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 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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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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PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area.

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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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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

JANUARY 17, 2021

The clinical trial to evaluate the safety and efficacy of the plasma-derived medicine will have doctors Oriol Mitjà and Bonaventura Clotet as the principal researchers and is expected to begin in early 2021. View original content to download multimedia: [link]. BARCELONA, Spain , Jan. BARCELONA, Spain , Jan.

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The ChEMBL-og

APRIL 16, 2024

See [link] and INN clinical candidate drugs (assigned as max_phase = 2 based on INN guidance that states “As a general guide, the development of a drug should progress up to the point of clinical trials (phase II) before an application is submitted to the INN Secretariat for name selection.”

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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

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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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

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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PerkinElmer

JUNE 7, 2021

Targeted cancer therapy has been a game changer in cancer treatment, significantly improving the survival and quality of life of many patients. Unlike chemotherapy, which acts on both cancer and normal cells, targeted therapy affects only the specific oncogenes, tumor suppressor genes, or pathways involved in tumor progression.

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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

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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Codon

FEBRUARY 13, 2024

Tom Ireland writes about the companies and technologies that are reimagining phage therapy. Soon after its publication, scientists, journalists, and investors were revisiting ‘phage therapy’ as a promising alternative to our failing antibiotics. Read it on our website here. Illustration by David S. Fast forward to 2023.

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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

SEPTEMBER 11, 2020

a clinical AI analytics platform, has partnered with iNDX.Ai , a data analytics and translation research platform, to launch a Covid-19 command center to accelerate research and development programs for therapies to prevent and treat Covid-19. Saama Technologies, Inc. , Source link.

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The Pharma Data

MAY 4, 2021

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients OLUMIANT ® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

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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

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. STOCKHOLM , Dec.

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The Pharma Data

DECEMBER 13, 2020

As part of the collaboration, Hummingbird will be leveraging Tempus’ AI-enabled platform and proprietary data, as well as joining its TIME Trial® Network, for rapid identification, site activation and efficient enrollment of cancer patients who have NRG1 fusions and meet eligibility criteria for HMBD-001 clinical trials.

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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

NOVEMBER 24, 2020

More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers. The drug candidate is currently engaged in a phase IIb clinical trial in prostate cancer, a study that aims to recruit more than 175 patients and that involves centres both in Europe and in the US.

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The Pharma Data

JANUARY 7, 2021

RMI), a global biotechnology company developing precision-targeted cancer therapies based on its proprietary, anti-cancer treatment platform, Illuminox , will present at the 39th Annual J.P. Outside of Japan, Illuminox therapies have not yet been approved as safe or effective by any regulatory authority. SAN MATEO, Calif. ,

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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

SEPTEMBER 27, 2021

Clinical Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory B-cell Non-Hodgkin’s Lymphoma (B-NHL) Published within the Lancet. The abstract is out there for download via the 16-ICML Virtual Platform. the complete manuscript is out there on The Lancet’s website.

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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 8, 2020

BioInvent International AB (OMXS: BINV) is a clinical stage company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapies, with two ongoing programs in Phase l/ll clinical trials for the treatment of hematological cancer and solid tumors, respectively. Visiting address: Sölvegatan 41.

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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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