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

Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Increases of ALT ?5x

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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

NOVEMBER 29, 2020

Small-molecule inhibitors of the MDM2-p53 protein-protein interaction (MDM2 inhibitors) in clinical trials for cancer treatment. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia , and China. View original content to download multimedia: [link]. ” References: Zhao, Y.; Aguilar, A.;

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PerkinElmer

JUNE 7, 2021

Despite observing marked interpatient variability in drug response, the screen identified sunitinib, a broad-specificity kinase inhibitor (KI), as the most effective FDA-licensed KI that was sufficient to counteract venetoclax resistance in the majority of patient cells.

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The Pharma Data

JANUARY 19, 2021

BioInvent’s management team will also give an update on the ongoing Phase I/IIa trial of BI-1206 in combination with rituximab and BioInvent’s partner CASI Pharmaceuticals (NASDAQ: CASI) will provide an update on the development plan and potential for BI-1206 in China. The Company’s validated, proprietary F.I.R.S.T

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The Pharma Data

NOVEMBER 23, 2020

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

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The Premier Consulting Blog

MAY 14, 2023

All clinical trial or marketing applications submitted to the FDA must include a form that summarizes the content of the submission and any relevant information on the sponsor and drug for the reviewers. Q: When I try to download the form, I receive a “please wait” message, and I never get redirected. How can I download the form?

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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. About CNS Pharmaceuticals, Inc.

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DrugBank

MARCH 22, 2024

Self-Hosting: These ontologies and datasets are often downloadable and can be used within your own servers, providing a high level of control over security and infrastructure. Their focus can be on anything from drug targets, indications, drug product details, clinical trial details, or drug categorization.

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The Pharma Data

JANUARY 22, 2021

iosBio , a UK-based biotechnology company, has announced an exclusive worldwide licensing agreement with ImmunityBio , a clinical-stage immunotherapy company, for rights to use iosBio’s OraPro vaccine platform technology to test the oral administration of ImmunityBio’s vaccine candidate. Download this exclusive report here.

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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

OCTOBER 27, 2020

We are pleased to see more vision-saving therapies moving toward clinical trials and potentially out to the people who urgently need them,” says Brian Mansfield , PhD, executive vice president research, interim chief scientific officer of the Foundation Fighting Blindness. . Source link.

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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

NOVEMBER 26, 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. SOURCE BioInvent. Source link.

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The Pharma Data

OCTOBER 26, 2020

AR-711 is an in-licensed mAb that is directed against the receptor binding domain of the SARS-Cov 2 virus. AR-201 is a fully human IgG1 mAb out-licensed preclinical program aimed at neutralizing diverse clinical isolates of respiratory syncytial virus (RSV). View original content to download multimedia: [link]. Source link.

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The Pharma Data

NOVEMBER 4, 2020

. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. The THRIVE-AA1 Phase 3 trial is a randomized, double-blind, placebo-controlled clinical trial of CTP-543 to evaluate hair regrowth using the Severity of Alopecia Tool (SALT) after 24 weeks of dosing in approximately 700 adult patients with moderate to severe alopecia areata.

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The Pharma Data

JANUARY 7, 2021

has been using an exclusively licensed antibody complex to develop new cancer therapies based on its Illuminox TM technology platform. is moving forward with product development by conducting clinical trials of monotherapy and combination therapy with other drugs. View original content to download multimedia: [link].

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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The Pharma Data

JANUARY 10, 2021

However, the global COVID-19 pandemic may still adversely impact Hansa Biopharma’s operational business and trial activities. Randomized Controlled Trial in the US Hansa is in ongoing discussions with the U.S. The following files are available for download: View original content: [link]. Pre-clinical programs.

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The Pharma Data

SEPTEMBER 29, 2020

To do so, we will work to expand clinical trials to account for diverse representation including lower-income settings and endeavor to address the specific product characteristics needed for use in lower-income settings even after new innovations are brought forward. . Download the Joint Communique (PDF 0.1

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The Pharma Data

JANUARY 18, 2021

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

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The Pharma Data

NOVEMBER 2, 2020

Although the FDA did not identify any filing issues with the NDA, the Agency reiterated a position raised during the Pediatric Advisory Committee (PAC) and Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) held on May 11, 2018 recommending two-year controlled trials in different age groups. In the U.S., About BioMarin.

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The Pharma Data

NOVEMBER 10, 2020

AlzeCure aims to pursue its own projects through preclinical research and development to an early clinical phase and is continuously working with business development to find suitable out-licensing solutions with other pharmaceutical companies. The following files are available for download: .

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The Pharma Data

OCTOBER 29, 2020

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. 10x ULN were observed in patients in Olumiant clinical trials.

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The Pharma Data

JANUARY 27, 2021

Entered an exclusive license and supply agreement with Accord Healthcare for ZUBSOLV® covering 29 European countries. 2021 will also require significant investments in OX124, as we enter the pivotal trial starting in the summer this year. The following files are available for download: View original content: [link].

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The Pharma Data

MAY 4, 2021

About OLUMIANT ® (baricitinib) OLUMIANT, a once-daily, oral JAK inhibitor was discovered by Incyte and licensed to Lilly. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and the Institute of Microbiology , Chinese Academy of Science (IMCAS). It is approved in the U.S.

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The Pharma Data

OCTOBER 14, 2020

FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX. View original content to download multimedia: [link]. Adverse Reactions. 215-891-6046. 484-539-9736.

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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 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

MAY 15, 2021

Download Your Copy Of The Chronic Fatigue Syndrome Solution Today to Discover: Jennifer, thank you once again for your prompt answer. Once you’ve downloaded your book, read the entire guide and start immediately! other licensed healthcare provider. Your consultations have been invaluable over this last month and a half.

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Codon

FEBRUARY 13, 2024

1 Yet even after more than two decades of research, media hype, and dozens of clinical trials and biotech start-ups that have come and gone, phage therapy has not scaled. No phage-based therapeutic has reached the latter stages of the clinical trial pipeline (where promising results lead to an expanded trial involving thousands of patients).

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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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The Pharma Data

DECEMBER 21, 2020

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 clinical development qualifies Ascentage Pharma for a milestone payment according to the terms of the licensing agreement. View original content to download multimedia: [link].

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Agency IQ

MAY 10, 2024

Similarly, while the agency’s guidance on the conduct of decentralized trials doesn’t “endorse any specific method” for remotely confirming patient/participant identify digitally, it does point sponsors to NIST’s Digital Identity Guidelines. health and tech), or delays while the FDA works to establish its own systems.

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The Pharma Data

DECEMBER 30, 2020

The proceeds from the Transaction would be primarily used to fund international multi-center trial for MVR-T3011-IT, IND filing and swift initiation of clinical trials for two additional pipeline candidates, as well as the discovery and validation of new product candidates developed on the OvPENS platform.

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