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To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinicaldevelopment.
Please click download to access this FREE resource. This report offers an unparalleled opportunity to explore the forefront of drug discovery and gain valuable insights from industry leaders and experts.
a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, today announced dose administration for the first patient in a Phase 2a clinical study of the company’s lead drug candidate, STP705, for the treatment of cutaneous basal cell carcinoma.
Cancer Research UK has partnered with Hummingbird Bioscience to advance this novel antibody drug into clinical trials for the treatment of HER3-driven cancer. Hummingbird Bioscience is an innovative clinical-stage biotech company focused on developing revolutionary therapies against hard-to-drug targets for improved treatment outcomes.
HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal antibody (mAb), for the treatment of adult patients with Myasthenia Gravis (MG). View original content to download multimedia: [link]. CAMBRIDGE, Mass.
14, 2021 (GLOBE NEWSWIRE) — Innovation Pharma (Formerly known as Cellceutix) (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to announce that the U.S. A molecular screening study of 11,552 compounds also supports Brilacidin as a promising novel coronavirus treatment. WAKEFIELD, Mass.,
7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment. Source link.
26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.
Roquinimex (Linomide), a drug developed by Pfizer for the treatment of multiple sclerosis, is structurally related to laquinimod. Figure 3: Roquinimex (linomide) Clinicaldevelopment of both laquinimod and roquinimex was halted due to serious cardiovascular events. In a 2021 publication, Rothhammer et al.
Her international experience in leading clinicaldevelopment 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 responses observed in six out of nine patients are very encouraging and clearly suggest that BI-1206 may restore the response to rituximab in patients who have few treatment alternatives. ET ) to discuss the results and next steps in clinicaldevelopment of BI-1206. CEO of BioInvent.
AR-711 exhibits high affinity for SARS-CoV-2 spike protein, approximately 10-fold or higher than mAb candidates currently in late stage clinical testing. AR-711 was previously shown to be effective in prophylactic as well as therapeutic treatment modes in a SARS-CoV-2 viral challenge study. About Aridis Pharmaceuticals, Inc.
Growing into a biopharmaceutical company, Innovent has built an integrated platform covering from drug discovery, CMC, clinicaldevelopment and commercialization. View original content to download multimedia: [link]. SAN FRANCISCO and SUZHOU, China , Nov. For more information, please visit: www.innoventbio.com. Source link.
Oncopeptides plans to initiate clinicaldevelopment 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. Headquarters is situated in Boston, Mass. Source link.
“Since becoming a public company, our clear focus has been on advancing the clinicaldevelopment of Berubicin. ”
As previously announced, the planned trial will evaluate the efficacy of Berubicin in patients with GBM who have failed primary treatment for their disease. .”
21, 2021 /PRNewswire/ — Dynacure , a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today the appointment of Jean M. View original content to download multimedia: [link].
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].
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. www.bioinvent.com.
Caris’ collaborative network focused on expanding the application of precision medicine in oncology supports Winship’s enterprising approach to research leading to transformative discoveries in cancer care and treatment. The NCTN serves as the NCI’s primary infrastructure to conduct phase II and III clinical trials.
SQI is accelerating the clinicaldevelopment of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.
View original content to download multimedia: [link].
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Mirati Therapeutics is a San Diego -based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. View original content to download multimedia: [link].
The event will feature a presentation by renowned lymphoma expert Mats Jerkeman, MD, Lund University, who will discuss the current treatment landscape, and unmet medical need for patients with relapsed or refractory Non-Hodgkin’s Lymphoma for whom current treatment options are very limited. SOURCE BioInvent.
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Experienced executive development team from Gilead Sciences.
a clinical-stage biotechnology company focused on developingtreatments for immunological and inflammatory diseases, today announced its launch backed by $80 million Series C financing led by Abingworth LLP.
SOUTH SAN FRANCISCO, Calif. ,
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.
14, 2021 /PRNewswire/ — MindMed (NEO: MMED), (OTCQB: MMEDF), (DE: MMQ), a leading psychedelic medicine biotech company today announced the addition of Robert Barrow , an accomplished pharmaceutical executive, as Chief Development Officer.
View original content to download multimedia: [link].
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Armata intends to use the net proceeds for the ongoing advancement of its bacteriophage development programs, including its FDA cleared first-in-human study, SWARM- P.a.
Initiate a Phase 1b /2 clinical trial evaluating AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia. .
ClinicalDevelopment – Pipeline Review.
The following files are available for download: View original content: [link]. .
3:40pm.
Setanaxib – Applications in Oncology.
Professor Gareth Thomas.
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“This result provides a foundation for a clinicaldevelopment program using higher doses of setanaxib across a variety of orphan indications. The following files are available for download: View original content: [link]. Significant improvement in fatigue was also achieved. ”, said CEO Renée Aguiar-Lucander.
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. SOURCE BioInvent.
“Both of our clinical candidates represent important opportunities for new medicines that we hope will have a meaningful impact on the lives of patients.”. CTP-543: An Investigational Treatment for Moderate to Severe Alopecia Areata.
CTP-692: An Investigational Adjunctive Treatment for Schizophrenia.
Amgen’s clinicaldevelopment team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRAS G12C ?inhibitor Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease.
No dose-limiting toxicities were observed and there were no fatal treatment-related adverse events (TRAEs). Eleven (18.6%) patients had grade 3 or higher TRAEs, one of whom had grade 3 TRAEs of ALT and AST increases that led to discontinuation of treatment. ” Amgen Webcast Investor Call Amgen?will Amgen, along with members of?Amgen’s
Background and reason
Moberg Pharma is a Specialty Pharma company focused on developing and commercialising proprietary, acquired and licensed products globally, from clinicaldevelopment of products based on proven substances to commercialisation. CET on November 6, 2020. SOURCE Moberg Pharma.
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UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. This progress in clinicaldevelopment qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. SUZHOU, China and ROCKVILLE, Md. ,
Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S.
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. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China. SOURCE Ascentage Pharma.
a clinical-stage biopharmaceutical company focused on discovering and developing a new generation of antibody therapeutics for oncology, announced today that the U.S. Vice President, Business Development
Apexigen
650-931-6236
mnevins@apexigen.com. View original content to download multimedia: [link].
“ This marks our second strategic agreement with Asieris, a well-run and well-capitalized company that is executing ahead of plan on the clinicaldevelopment of Cevira ®, which we licensed to them in July 2019. but with a healthcare system that is still developing. 75% of all bladder cancer cases occur in men.
This is the fourth ODD granted to APG-2575 by the US FDA, following the previous ODDs for the treatment of Waldenström macroglobulinemia (WM), chronic lymphocytic leukemia (CLL), and multiple myeloma (MM). Cancer Treatment and Survivorship Statistics, 2014. Any of these intentions may alter in light of future development.
BT-001 is being co-developed through a 50/50 collaboration between BioInvent and Transgene. “This clinical trial approval sets the stage to further broaden BioInvent’s promising clinical pipeline. BT-001 is our fourth program in clinicaldevelopment. LUND, Sweden and STRASBOURG, France , Dec.
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. .
In patients without liver metastases, an ORR of 34.8%
Contribution of these robust data sets from industry led trials is critical to TOMI-T1D’s work in developing innovative and quantitative tools that can facilitate clinicaldevelopment efforts and be endorsed by regulators for future use by the pharmaceutical industry to optimize the design of future clinical trials.
The EUA is based on results from four randomised, controlled studies that evaluated Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalised patients. Roche’s Chief Medical Officer and Head of Global Product Development. Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S.
Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase 2 part of the study. ” In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1.
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