The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19. Regenerative medicine and advanced therapies thriving despite Covid-19 disruption.

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The Pharma Data

DECEMBER 22, 2020

Approximately 74 patients are planned for this trial in Head and Neck Squamous Cell Carcinoma (HNSCC) and Cutaneous Squamous Cell Carcinoma (CuSCC). The trial will enroll three cohorts of patients within distinct populations – all with locally advanced, recurrent and/or metastatic HNSCC or locally advanced or metastatic CuSCC.

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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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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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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 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

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

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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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 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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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

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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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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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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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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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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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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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

DECEMBER 20, 2020

“This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. Philippe Archinard , PhD, Chairman and CEO of Transgene, said: “We are pleased that we have received a first approval to initiate the Phase l/lla trial of BT-001. LUND, Sweden and STRASBOURG, France , Dec.

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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

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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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

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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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 10, 2020

While the world is facing a severe shortage of specific antiviral drugs, a new treatment developed by Asclepius Meditec highlights the potential of hydrogen-oxygen therapy in tackling COVID-19. View original content to download multimedia: [link]. The paper has been contributed and under review. 1798/1795, info@ascleway.com.

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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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