The Pharma Data

DECEMBER 14, 2020

This grant will support Alume’s clinical development of its novel nerve illumination technology in surgery. Alume previously received a Phase I SBIR grant in 2019 from the NINDS to develop nerve illumination agents for surgical use. View original content to download multimedia: [link]. About Alume Biosciences, Inc.

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PPD

JUNE 13, 2023

Clinical trials for COVID-19 vaccines changed how all vaccine trials are conducted. The success of the COVID-19 vaccines has brought renewed interest to vaccine development across indications and therapeutic areas. See how the right vaccine development partner can make all the difference.

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The Pharma Data

JANUARY 31, 2021

Adjuvanted S-Trimer COVID-19 vaccine candidates demonstrated favorable safety and tolerability profiles and strong neutralizing immune responses in a phase 1 trial. Clover plans to initiate a global phase 2/3 trial in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021.

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The Pharma Data

JANUARY 13, 2021

.” MindMed Chief Development Officer Rob Barrow said, “Psychedelic therapies offer a once in a lifetime opportunity to revolutionize the delivery of mental healthcare. View original content to download multimedia: [link]. Media Contact: mindmed@150bond.com.

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The Pharma Data

SEPTEMBER 11, 2020

a clinical AI analytics platform, has partnered with iNDX.Ai , a data analytics and translation research platform, to launch a Covid-19 command center to accelerate research and development programs for therapies to prevent and treat Covid-19. Saama Technologies, Inc. , Source link.

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PPD

NOVEMBER 21, 2023

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 clinical development.

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The Pharma Data

JANUARY 6, 2021

With the IND approval, UNION is granted permission to advance oral orismilast into Phase 2b trials in humans with moderate to severe plaque psoriasis to evaluate the safety and efficacy of orismilast. We confidently believe in the benefits of oral orismilast, and the IND approval marks a significant milestone in our clinical development.”

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The Pharma Data

DECEMBER 27, 2020

28, 2020 /PRNewswire/ — Alligator Bioscience (Nasdaq Stockholm: ATORX) today announced that it has submitted a CTA (Clinical Trial Authorization) application to the relevant regulatory authorities to start a Phase II efficacy study of its wholly-owned CD40 targeting antibody mitazalimab. LUND, Sweden , Dec.

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The Pharma Data

OCTOBER 14, 2020

We are evaluating APX005M in a broad clinical program that includes more than 10 clinical trials in various indications and therapeutic combinations,” said Xiaodong Yang , MD, PhD, Chief Executive Officer of Apexigen. Additional information on clinical trials for APX005M can be found at www.clinicaltrials.gov.

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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. SOURCE BioInvent.

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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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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. www.bioinvent.com.

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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. that are fast progressing clinical trials. View original content to download multimedia: [link]. TYVYT® is the only PD-1 inhibitor included in the NRDL.

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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. “Since becoming a public company, our clear focus has been on advancing the clinical development of Berubicin.

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The Pharma Data

JANUARY 27, 2021

Considering the effects of the global pandemic, provision of additional resources can also be the difference between sites being able to continue to deliver clinical research projects or having to suspend activities,” said Kerry Dyson , Chief Operating Officer at CROMSOURCE. View original content to download multimedia: [link].

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The Pharma Data

DECEMBER 3, 2020

IND approval by the US Food and Drug Administration (FDA) is a prerequisite to start clinical trials in the USA. “While the upcoming clinical Phase Ib/II study in pancreatic cancer, OPTIMIZE-1, will be starting in Europe , the IND opens up for later expansion in the US. LUND, Sweden , Dec. SOURCE Alligator Bioscience.

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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

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. CET ( 11:30 a.m.

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The Pharma Data

JANUARY 10, 2021

(Nasdaq:IDYA), an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics, today announced it has submitted an Investigational New Drug (IND) application with the U.S. View original content to download multimedia: [link]. Securities and Exchange Commission. Source link.

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The Pharma Data

OCTOBER 19, 2020

With over 300 active clinical trials, Winship researchers are dedicated to taking new cancer treatments from bench to bedside. cancer centers selected as a Lead Academic Participating Site for the NCI’s National Clinical Trials Network (NCTN). Winship is one of 32 U.S.

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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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The Pharma Data

DECEMBER 15, 2020

The Phase III trial evaluated the use of the diabetes vaccine Diamyd ® , an antigen-specific immunotherapy based on the auto-antigen GAD (glutamic acid decarboxylase), to induce immunological tolerance and stop the autoimmune destruction of insulin producing cells. Diamyd Medical develops therapies for type 1 diabetes.

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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. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, and China. Source link.

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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 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

OCTOBER 25, 2020

SQI is accelerating the clinical development 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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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 14, 2021

. Pathophysiology of IgA nephropathy & Nefecon Clinical Biomarker Data. A Review of the Phase 3 NefIgArd Trial Data. Clinical Development – Pipeline Review. Clinical Development – Pipeline Review.

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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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Agency IQ

AUGUST 23, 2024

EMA issues more updates to prepare for clinical trials transition Offices throughout the EU—including those of the EMA—have slowed operations for the summer holiday, but that didn’t keep the EMA from publishing a stack of updated documents.

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The Pharma Data

JUNE 26, 2021

Roche-sponsored global trials included the placebo-controlled EMPACTA, COVACTA and REMDACTA studies. FDA Letter of Authorisation and Fact Sheets for patients and health care professionals are available for download with the latest information on this EUA. About the Actemra/RoActemra COVID-19 Clinical Trial Programme.

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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.

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The Pharma Data

JANUARY 4, 2021

Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia , and China. Any of these intentions may alter in light of future development.

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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. SUZHOU, China and ROCKVILLE, Md. ,

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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.

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The Pharma Data

OCTOBER 29, 2020

20 defined as having 20% or less of scalp hair loss and considered as clinically meaningful improvement, was significantly greater in baricitinib 2-mg (33.3%, p=0.016), and 4-mg (51.9%, p=0.001) groups compared to placebo (3.6%). vice president of immunology development at Lilly. View original content to download multimedia: [link].

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PPD

JUNE 17, 2024

Each model delivers a distinct set of capabilities to the study sponsor: In an FSP arrangement, the contract research organization (CRO) performs a specific function or multiple functions (clinical operations, pharmacovigilance, etc.) across protocols, medicinal products, a portfolio of studies or the entire company.

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