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In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drugdevelopers for phase I trials, second only to navigating regulatory compliance (- 38 percent). Biomarkers can play a crucial role throughout clinicaldevelopment, especially in early phases.
The drugdevelopment industry is constantly adapting and evolving to bring novel therapeutics to market to improve the lives of patients across the globe. While the drugdevelopment industry experienced setbacks during the COVID-19 pandemic, the field is again gaining momentum reminiscent of its pre-pandemic pace.
Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinicaldevelopment and commercialization. By joining Innovent, Dr. Liu will be responsible for global R & D, pipeline strategy, business development and international operations.
This has opened new opportunities in pharmaceutical drugdevelopment, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.
The NCT03763149 study is a phase 1a clinical study evaluating the tolerability, safety, and PK/PD properties of IBI188 (letaplimab) as monotherapy for advanced malignancies that failed in standard treatments.
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SAN FRANCISCO , U.S. and SUZHOU, China , Nov.
27, 2020 10:45 UTC. –( BUSINESS WIRE )– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020.
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for the third quarter of 2020. .
for the third quarter of 2020. KENILWORTH, N.J.–(
It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinicaldevelopment process.
5, 2020 /PRNewswire/ — Third quarter 2020 revenues increased 32% to $2.29 Third quarter 2020 EYLEA ® U.S. Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07 Third quarter 2020 Dupixent ® global net sales (2) , which are recorded by Sanofi, increased 69% to $1.07
How do AI-enhanced approaches accelerate the drugdevelopment process for rare diseases? AI holds the potential to revolutionise different aspects of healthcare, particularly in the realm of clinical trials. In 2020, 78 percent of orphan drugs and biologics approved were targeted therapies.
The increasing costs associated with in-house drugdevelopment have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Still in its early stages, Vial was established in 2020 and has quickly emerged as a leading CRO.
29, 2020 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that the company has appointed Dr Christina Reimer as Chief Medical Officer. Her international experience in leading clinicaldevelopment and in building development organizations will significantly strengthen our clinical capacity. .
11, 2020 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain. executive vice president of research and development. “The executive vice president of research and development. “We THE WOODLANDS, Texas, Dec.
The project also seeks to engage the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to identify opportunities for regulatory endorsement of such drugdevelopment tools. The Diamyd Medical data includes relevant information about disease progression, drug effects and clinical trial design.
28, 2020 (GLOBE NEWSWIRE) — Gritstone Oncology , Inc. The newly executed PIPE financing is subject to customary closing conditions and is expected to close on December 30, 2020, and was done in compliance with applicable Nasdaq rules and priced at the “Minimum Price” (as defined in the Nasdaq rules). and Versant Ventures.
19, 2020 08:02 UTC. DUBLIN–( BUSINESS WIRE )– Inflection Biosciences Ltd , a company developing innovative therapeutics for the treatment of cancer, today announced the appointment of industry veteran Gregory I. Greg possesses a wealth of experience in developing new cancer therapeutics across multiple U.S.
26, 2020 11:00 UTC. We are advancing the clinicaldevelopment of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. CAMBRIDGE, Mass.–( About Moderna.
2, 2020 — An experimental antibody drug that targets one of the body’s key metabolism regulators may help obese people lose weight — at least briefly. That’s one finding from an early study that tested the injection drug, which mimics the effects of a natural hormone called fibroblast growth factor 21 (FGF21).
In lean times such as 2023, we saw a shift towards several “hot” areas driven by massive commercial potential, clinically (± commercially) validated mechanisms, and exits that encouraged further investing, even at the early stage. Figure 2 shows pipelines across modalities for some of the competitive targets today.
CNS-related issues account for nearly a quarter of failures during clinicaldevelopment, a phase where consequences are high in terms of resources and patient impact. CNS-related issues account for nearly a quarter of failures during clinicaldevelopment, a phase where consequences are high in terms of resources and patient impact.
The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drugdevelopers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.
15, 2020 /PRNewswire/ — Armata Pharmaceuticals , Inc. to reflect the manner in which phage attack dangerous pathogens, will be our Company’s first clinical trial to evaluate a phage-based therapy as a potential treatment for Pseudomonas aeruginosa airway infections.
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MARINA DEL REY, Calif. ,
4, 2020 08:00 UTC. Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinicaldevelopment for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
14, 2020 10:00 UTC. which develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases, today announced the appointment of Bo Zhang, Ph.D., as Head of Business Development. BEIJING & CAMBRIDGE, Mass.–( He received his B.S.
28, 2020 /PRNewswire/ — Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, today announces the formation of a new Scientific Advisory Board (SAB). OSLO, Norway , Oct. Fennel cover the key scientific focus areas of Targovax.
04, 2020 (GLOBE NEWSWIRE) — LogicBio Therapeutics , Inc. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical candidate, LB-001 for the treatment methylmalonic acidemia (MMA). LEXINGTON, Mass., Commenting on the announcement, Daniel Gruskin, M.D., About LogicBio Therapeutics.
At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. “We In fiscal 2020, the Group employed around 100,000 people and had sales of 41.4
Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA’s preclinical and clinicaldevelopment programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Securities and Exchange Commission.
As announced in January 2020, the trial met the primary endpoint of statistically significant improvement in progression-free survival (PFS), as assessed by independent review committee (IRC), in the pre-planned interim analysis. Accessed December 2020. Accessed December 2020. About Non-Small Cell Lung Cancer. v Zhang, T.,
Contract research organizations (CROs) are an integral partner of the drugdevelopment process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies.
28, 2020 /PRNewswire/ — Novotech Health Holdings (“Novotech Holdings”), the largest biotech specialist contract research organization (CRO) in Asia , today announced the appointment of Zidong Zhang as Chief Financial Officer (CFO) effective 4 January 2021. SHANGHAI and SYDNEY , Dec.
27, 2020 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today announced that the U.S. NEW YORK, Oct. Founder and Chief Executive Officer of Prevail.
Our lead candidate, ibrexafungerp (formerly known as SCY-078), is a broad-spectrum, IV/oral antifungal agent representing a novel therapeutic class, in late stage development for multiple indications, ranging from vaginal yeast infections to life-threatening fungal infections in hospitalized patients. JERSEY CITY, N.J.,
29, 2020 06:00 UTC. Over the past nine years, Moderna has invested in creating and developing a novel platform for designing and manufacturing a new class of mRNA-based vaccines. CAMBRIDGE, Mass.–( –( BUSINESS WIRE )– Moderna, Inc. A summary of the company’s work to date on COVID-19 can be found here.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinicaldevelopment or gain health authority approval. About Eisai Co., Source link:
Leading Global CROs To advance new therapies, pharma, biotech, and medical device sponsors engage CROs to help navigate the complex landscape of drugdevelopment and regulatory pathways and to manage clinical trials efficiently, ethically, and in compliance with good clinical practice ( GCP ) standards.
ET ) to discuss the results and next steps in clinicaldevelopment of BI-1206. Two preclinical programs in solid tumors are expected to enter clinical trials by the end of 2020. .”
BioInvent will hold a key opinion leader (KOL) call today, Thursday, January 28 at 5:30 p.m. CET ( 11:30 a.m.
Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. 2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinicaldevelopment.
In-licensed from Merck KGaA, Darmstadt, Germany , atacicept has been studied previously in autoimmune diseases and shown to reduce autoantibodies in a dose-dependent fashion with once-weekly subcutaneous dosing and has a well-established and acceptable clinical safety profile.
26, 2020 (GLOBE NEWSWIRE) — BioXcel Therapeutics, Inc. (“BTI” is a clinical stage biopharmaceutical company focused on drugdevelopment that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology. NEW HAVEN, Conn., BioXcel Therapeutics, Inc. BioXcel Therapeutics, Inc.
Such forward-looking statements involve substantial risks and uncertainties that could cause Gritstone’s research and clinicaldevelopment programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Gilead Forward-Looking Statements.
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“Multi-drug resistant bacterial infections are a serious and growing public health threat, and with two strong therapeutic candidates and a robust team to drive clinicaldevelopment, we believe we are well positioned to be a leader in the innovative field of phage therapy,” said Todd R. per share.
27, 2020 06:30 UTC. Following the unauthorized download of all abstracts on the SITC website, Transgene is communicating the content of the late-breaking poster abstract that will be presented at the SITC 35th Anniversary Annual Meeting (SITC 2020), to be held virtually November 9-14, 2020.
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15, 2020 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq: VBLT), today announced that the European Patent Office (EPO) has granted Patent # 3328401 , which covers VBL’s proprietary investigational anti-MOSPD2 monoclonal antibodies to treat oncology conditions. TEL AVIV, Israel, Oct.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinicaldevelopment or gain health authority approval. About Eisai Co.,
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