Fierce BioTech

MAY 24, 2023

Making the best use of the modern tools at their disposal, allied to skills and expertise developed across multiple lead optimization programs in the past, will make success more likely. Download now! jsabatino Wed, 05/24/2023 - 12:56 In a lead optimization program, there is no substitute for experience.

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The Pharma Data

SEPTEMBER 16, 2020

executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C inhibitor sotorasib (AMG 510). Reese , M.D., On Monday, Sept. PDT , David M.

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Alta Sciences

JUNE 9, 2023

Key resources for ethnobridging in Phase I clinical trials: In this issue of The Altascientist , we demonstrate how ethnobridging can prevent the need for region-specific development programs, helping you safely achieve commercial milestones more efficiently. Download your copy today. In this complimentary webinar , Mel B.

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PPD

JUNE 17, 2024

Our PPD FSP solutions help biotech and biopharmaceutical companies meet their timelines by providing top-tier functional expertise that complements existing capabilities and helps companies tackle their unique clinical development challenges.

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Clinical Trials Clinical Development Trials International 52

PPD

OCTOBER 2, 2024

For our clients, the ability to outsource these capabilities is a marked improvement compared to hiring, training and maintaining a large workforce to fulfill every aspect of clinical operations — a feat made even more complicated by workloads that can fluctuate widely depending on the number of products under development.

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PPD

JUNE 13, 2023

To rise above the competition, sponsors must understand the common pitfalls of vaccine development and have strategies in place to avoid them. It is imperative that the right vaccine development partner demonstrates expertise from early clinical development to study design, execution, regulatory submission and commercialization.

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Vaccine Clinical Trials Clinical Research Trials 52

The Pharma Data

DECEMBER 27, 2020

Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc. In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. SOURCE Alligator Bioscience.

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Clinical Trials Clinical Development Trials Drugs 52

The Pharma Data

DECEMBER 28, 2020

Her international experience in leading clinical development and in building development organizations will significantly strengthen our clinical capacity. This is crucial in the phase we are in now, with two products on the way to Phase II and another product in clinical Phase I. SOURCE Alligator Bioscience.

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The Pharma Data

JANUARY 7, 2021

This platform has enabled Apexigen and its collaboration partners to discover and develop high-quality therapeutic antibodies against a variety of molecular targets, including targets that are difficult to drug with conventional antibody technologies. View original content to download multimedia: [link]. SOURCE Apexigen, Inc.

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Clinical Development International Production Drugs 40

The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. View original content to download multimedia: [link]. (Alume) announced today that it has been awarded a $2.5M Contact: Catherine Eng , catherine.eng@alumebiosciences.com. SOURCE Alume Biosciences. Source link.

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The Pharma Data

JANUARY 6, 2021

He continues: “With the green light granted by the FDA to continue our clinical research, we are one step closer to offering psoriasis patients a novel, improved oral treatment option and thereby enhancing their quality of life. The following files are available for download: View original content: [link]. Sources 1: Li et al.

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FDA Approval FDA Clinical Development Clinical Research 52

Conversations in Drug Development Trends

MARCH 7, 2024

Understanding the nuances of each pathway is crucial for small to midsize companies aiming to navigate the complexities of global clinical development successfully. For additional insights, download our full white paper, “ First-in-Human Studies: IND or CTA? ”.

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Clinical Trials Trials FDA Drug Development 52

The Pharma Data

AUGUST 7, 2020

Most importantly, we are continuing to see patients benefit from the profound therapeutic effects of both approved products and those currently in clinical development. Download the e-book here. We are committed to bringing these life-changing therapies to patients in need,” Lambert added.

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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. View original content to download multimedia: [link].

Therapies 52

Therapies Clinical Trials Laboratories Science 52

The Pharma Data

SEPTEMBER 11, 2020

“The Covid-19 command center is customized to meet immediate needs related to research on the novel coronavirus, but can also be used more broadly for other infectious disease clinical development efforts now and in the future.”.

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Clinical Trials Pharma Companies Trials Hospitals 52

The Pharma Data

OCTOBER 14, 2020

APX005M is currently in Phase 2 clinical development for the treatment of cancers such as pancreatic cancer, esophageal and gastroesophageal junction cancers, melanoma, non-small cell lung cancer, rectal cancer and sarcoma in various combinations with immunotherapy, chemotherapy, radiation therapy or a cancer vaccine. Source link.

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The Pharma Data

DECEMBER 29, 2020

The expansion of the eligible stocks of Hong Kong Stock Connect, will further optimize the interconnected, intercommunicated, and mutual development of the capital markets between Mainland China and Hong Kong. Any of these intentions may alter in light of future development. View original content to download multimedia: [link].

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Clinical Development FDA Regulations Clinical Trials 52

The Pharma Data

NOVEMBER 10, 2020

Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinical development and commercialization. View original content to download multimedia: [link]. Michael Yu reviewed the history and achievements in the past nine years since the establishment of Innovent.

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Biosimilars Clinical Trials International Clinical Development 52

The Pharma Data

JANUARY 27, 2021

We are excited to expand our strategic site support services and look forward to providing even more sites and clients with the expert resources needed to deliver world class, innovative clinical research in keeping with the new normal in our industry.” View original content to download multimedia: [link]. Logo – [link].

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Clinical Research Clinical Trials International Clinical Development 40

The Pharma Data

DECEMBER 3, 2020

Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc.). In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. SOURCE Alligator Bioscience.

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Clinical Trials Clinical Development FDA Trials 40

The Pharma Data

OCTOBER 27, 2020

Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule and selective KRAS G12D inhibitor in preclinical development. View original content to download multimedia: [link]. Source link.

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Small Molecule Immune Response Clinical Development Clinical Trials 52

The Pharma Data

DECEMBER 14, 2020

“Filing an IND with the FDA is an important step in the clinical development of Rabeximod. It is a quality stamp on our drug candidate and Covid-19 trial and would enable us to expand the clinical development to the United States. The following files are available for download: View original content: [link].

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Metabolite Tales Blog

NOVEMBER 17, 2022

Roquinimex (Linomide), a drug developed by Pfizer for the treatment of multiple sclerosis, is structurally related to laquinimod. Figure 3: Roquinimex (linomide) Clinical development of both laquinimod and roquinimex was halted due to serious cardiovascular events. This was unexpected. The fun slides are at the end.

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International Licensing Licensing Treatment 52

The Pharma Data

JANUARY 10, 2021

Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Securities and Exchange Commission.

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The Pharma Data

NOVEMBER 25, 2020

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering. The following files are available for download: View original content: [link].

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Clinical Trials Licensing Licensing International 52

The Pharma Data

DECEMBER 8, 2020

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the company’s own clinical development pipeline or for additional licensing and partnering. The following files are available for download: View original content: [link].

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The Pharma Data

JANUARY 27, 2021

This Breakthrough Therapy designation will enable the accelerated development of Batoclimab for MG thereby bringing this life-changing innovative drugs to patients in China sooner.” View original content to download multimedia: [link]. ” he added. About Harbour BioMed. Harbour BioMed (HKEX: 02142.HK) Source link.

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Therapies Treatment International Licensing 40

The Pharma Data

OCTOBER 18, 2020

Oncopeptides plans to initiate clinical development of OPD5 with an open-label phase 1, dose escalation study on safety and tolerability of OPD5 as a myeloablative regimen followed by Autologous Stem Cell Transplantation in patients with relapsed refractory multiple myeloma. More information is available on www.oncopeptides.com.

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FDA Drugs Pharmaceutical Companies Treatment 40

PPD

NOVEMBER 30, 2023

We empower sponsors by providing access to diverse populations, promoting technological innovation in clinical development and co-creating partnership models optimized for success. Together, we will leverage these trends to accelerate your drug development initiatives into the new year and beyond.

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The Pharma Data

JANUARY 27, 2021

ET ) to discuss the results and next steps in clinical development of BI-1206. technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering.

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Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

OCTOBER 26, 2020

AR-301 is a fully human IgG1 mAb currently in Phase 3 clinical development targeting gram-positive Staphylococcus aureus ( S. AR-101 is a fully human immunoglobulin M, or IgM, mAb in Phase 2 clinical development targeting Pseudomonas aeruginosa ( P. View original content to download multimedia: [link].

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The Pharma Data

NOVEMBER 4, 2020

Furthermore, there are two partnered assets: ALG.APV-527 in co-development with Aptevo Therapeutics Inc. and AC101 in clinical development by Shanghai Henlius Biotech Inc.). In addition, the company has developed a novel concept for more patient-specific immunotherapy: Neo-X-Prime. SOURCE Alligator Bioscience.

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Packaging Clinical Development Disease Drugs 40

The Pharma Data

JANUARY 20, 2021

” “Dynacure is a leader in rare disease drug development, as evidenced by its lead product candidate DYN101, which is in clinical development for the treatment of Myotubular and Centronuclear Myopathies for which there are no FDA or EMA approved therapeutics,” said Ms. ” Ms. SOURCE Dynacure.

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Treatment Pharmaceuticals Drug Development Science 40

The Pharma Data

NOVEMBER 23, 2020

View original content to download multimedia: [link]. . SOURCE Synthetic Biologics, Inc. . Source link.

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Compliance Licensing Licensing Clinical Trials 52

The Pharma Data

JANUARY 17, 2021

Members of the senior management team have a combined experience in the biopharmaceutical industry, spanning clinical development, regulatory, financial and business management in both the USA and China. View original content to download multimedia: [link]. SOURCE Sirnaomics, Inc. Source link.

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Treatment Trials FDA Approval RNA 52

The Pharma Data

JANUARY 19, 2021

technology platform simultaneously identifies both targets and the antibodies that bind to them, generating many promising new drug candidates to fuel the Company’s own clinical development pipeline or for additional licensing and partnering. The following files are available for download: View original content: [link].

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Clinical Trials Licensing Licensing International 40

The Pharma Data

JANUARY 18, 2021

“The strong support of our syndicate reflects strong conviction in Vera’s clinical development experience and the potential of our lead asset to target the source of immune complexes in patients with IgAN and change the standard of care,” said founder and CEO Marshall Fordyce , MD. SOURCE Vera Therapeutics.

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