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

NOVEMBER 23, 2020

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

Compliance 52

Compliance Licensing Licensing Clinical Trials 52

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 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.

Trials 52

Trials Production Clinical Trials Government 52

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.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

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

Clinical Trials 40

Clinical Trials Licensing Licensing International 40

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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Vaccine Immune Response Government RNA 52

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.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Licensing Licensing 52

The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. Protalix has licensed to Pfizer Inc.

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Disease Treatment Clinical Trials FDA 52

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 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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Clinical Trials Licensing Licensing International 52

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 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?

FDA 52

FDA Clinical Trials Licensing Licensing 52

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.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Treatment 52

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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Virus International Trials Clinical Trials 40

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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FDA Clinical Trials Drugs Therapies 40

The Pharma Data

JANUARY 31, 2021

is a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of MD Anderson Cancer Center. View original content to download multimedia: [link]. out of 10. . Join our more than 200K subscribers here to follow the Company: [link].

FDA 52

FDA Treatment Clinical Trials Licensing 52

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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Packaging FDA Trials Regulations 52

The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021. SOURCE Amgen.

Clinical Trials 52

Clinical Trials Production Trials Government 52

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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Therapies Treatment Trials Disease 40

The Pharma Data

SEPTEMBER 20, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen ‘s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in 2021. 2016;33:32.

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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].

Disease 40

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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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Drugs FDA Treatment Pharmaceuticals 40

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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Pharmaceutical Companies Disease Treatment Pharmaceuticals 40

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 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.

Clinical Trials 52

Clinical Trials Therapies Trials Production 52

The Pharma Data

JANUARY 17, 2021

. “Rolontis,” a treatment for neutropenia that had its technology licensed out to Spectrum Pharmaceuticals, Inc. and “Oraxol,” which was licensed out to Athenex, Inc. Belvarafenib (HM95573, solid tumor) , which was licensed to Genentech, Inc., It will enter a Phase 2 clinical trial this year.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

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.;

Licensing 40

Licensing Licensing Small Molecule Clinical Trials 40

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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Clinical Development Disease Treatment Licensing 40

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.

Treatment 52

Treatment Clinical Trials Therapies Trials 52

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.

Disease 40

Disease Treatment FDA Licensing 40

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.

Doctors 52

Doctors Production Therapies Treatment 52

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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Clinical Trials Therapies Trials Licensing 40

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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Therapies Production Treatment FDA 40

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.

FDA Approval 40

FDA Approval FDA Treatment Clinical Trials 40

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Trademarks are owned by or licensed to Janssen and the ViiV Healthcare group of companies. View original content to download multimedia: [link]. This list of uses in specific populations is not complete.

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FDA Approval Treatment RNA FDA 52

The Pharma Data

JULY 12, 2021

EUA Statement on All Materials: The Janssen COVID-19 Vaccine has not been approved or licensed by the U.S. The Janssen COVID-19 Vaccine is still being studied in clinical trials. For further information on the safety of authorized COVID-19 vaccines, please visit: [link]. Statement updated 9:00pm ET]. Janssen COVID-19 CONSUMER EUA ISI.

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