Drug Discovery World

JANUARY 19, 2023

A pilot Phase IIa clinical trial evaluating Abionyx Pharma’s CER-001 as a treatment for septic patients at high risk of developing acute kidney injury (AKI) has met its primary endpoint. million related deaths globally. “The trial shows promising positive results across a variety of primary and secondary endpoints.

Drugs 52

Drugs Trials Containment Clinical Trials 52

Pfizer

AUGUST 3, 2022

Decision follows results of interim futility analysis which indicate Phase 3 REALM-DCM trial unlikely to meet primary endpoint. Based on these results, the Phase 3 trial and further development of PF-07265803 will be discontinued. The information contained in this release is as of August 3, 2022. Disclosure Notice.

Development 101

Development Vaccination Vaccine Production 101

The Pharma Data

JANUARY 13, 2021

HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC®) targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells. About the Phase 1/2 Trial for HPN217. HPN217 is covered by a global development and option agreement with AbbVie Inc. NYSE: ABBV).

Drugs 52

Drugs Containment Clinical Trials Clinical Trials 52

The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. “We

Clinical Trials 52

Clinical Trials Clinical Trials Trials Containment 52

The Pharma Data

JANUARY 10, 2021

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / January 11, 2021 / MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that Jean-Paul Kress, M.D.,

Containment 52

Containment Clinical Development Antibody Development 52

pharmaphorum

DECEMBER 2, 2021

In September, it reported a fourth patient death in a clinical trial of its AT132 (resamirigene bilparvovec) gene therapy for the rare disease X-linked myotubular myopathy (XLMTM), possibly linked to liver side effects. Those safety issues have hit Astellas’ aspirations in gene therapy directly.

Gene Therapy 79

Gene Therapy Gene Manufacturing Containment 79

The Pharma Data

NOVEMBER 9, 2020

Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax’ nanoparticle technology and includes its proprietary MatrixM adjuvant. Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. and globally.”.

Vaccination 52

Vaccination Vaccine Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 10, 2020

“We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible.”. Safe Harbor Statement.

Containment 52

Containment Clinical Development Development Protein 52

The Pharma Data

JANUARY 14, 2021

(NASDAQ: FPRX) today announced clinical results from the global, randomized, double-blind placebo-controlled Phase 2 FIGHT trial evaluating first-in-class targeted therapy bemarituzumab in advanced gastric or gastroesophageal junction (GEJ) cancer. Phase 2 FIGHT Trial: Summary of Efficacy*. Wainberg, M.D.,

Trials 52

Trials HR Containment Development 52

The Pharma Data

JANUARY 4, 2021

The panel is entitled “Separating the Wheat from the Chaff: Most Promising Novel Oncology Targets in Development”. Polyphor is currently conducting the Phase III FORTRESS trial with balixafortide, a potent and selective CXCR4 antagonist, in patients with HER2 negative, locally recurrent or metastatic breast cancer.

Bacteria 52

Bacteria Containment Development Protein 52

The Pharma Data

OCTOBER 25, 2020

We are advancing the clinical development 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. On Thursday, October 22, Moderna completed enrollment of the Phase 3 COVE study. About Moderna. Forward-Looking Statements.

Vaccination 52

Vaccination Vaccine Manufacturing Clinical Development 52

pharmaphorum

OCTOBER 14, 2021

The protein, Programmed Death-Ligand 1 (PD-L1), is found on the surface of many cells throughout the body. Some cancer cells contain large amounts of PD-L1, which helps them to evade the body’s immune system.

HR 45

HR Containment Protein Clinical Development 45

The Pharma Data

DECEMBER 13, 2020

The DSMB indicated that the Phase III clinical study should continue without modifications. “We are pleased with the DSMB recommendation that the Phase III clinical trial continues without any protocol modification,” said Frank Weber, MD, CMDO of Polyphor. ALLSCHWIL, Switzerland, Dec. ALLSCHWIL, Switzerland, Dec.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Bacteria 52

The Pharma Data

DECEMBER 29, 2020

As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. The primary clinical objective of this initial analysis was to determine if there was sufficient efficacy in these patients to warrant continuing the trial (i.e.,

Antibody 52

Antibody Trials Production Clinical Trials 52

The Pharma Data

OCTOBER 28, 2020

We appreciate the confidence of the MHLW in Moderna and mRNA-1273, which we hope will help address the pandemic, especially given the encouraging data we have recently published together with the NIH related to the clinical trial in the elderly and older adult population,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We

Vaccination 40

Vaccination Vaccine Manufacturing Containment 40

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. About Cantargia. Cantargia AB (publ), reg.

Antibody 52

Antibody Manufacturing Clinical Trials Clinical Trials 52

Pfizer

JULY 26, 2022

Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef. Tue, 07/26/2022 - 17:41.

Vaccination 111

Vaccination Vaccine Protein Immune Response 111

The Pharma Data

DECEMBER 10, 2020

The vaccine targeted both the inner nucleocapsid (N) and the outer spike (S) proteins of the virus to maximize the immune response. Pending discussions with the FDA, the oral vaccine will enter Phase I trials as a prime and boost, and will be explored to provide a boost to subcutaneous vaccinations.

Vaccination 52

Vaccination Vaccine Immune Response Protein 52

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4

Antibody 40

Antibody Trials Production Clinical Trials 40

The Pharma Data

AUGUST 25, 2020

senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. In the AG221-C-001 Phase 2 clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. WARNINGS AND PRECAUTIONS. In certain countries outside the U.S.,

Trials 52

Trials FDA Approval Development Clinical Trials 52

XTalks

JANUARY 5, 2021

The pandemic itself will also continue to spur innovations and changes such as greater shifts towards decentralized clinical trials and patient-centric approaches. In addition to vaccines, there are handfuls of drugs currently being evaluated in clinical trials for the treatment of COVID-19.

Life Science 98

Life Science Clinical Trials Clinical Trials Trials 98

The Pharma Data

JULY 18, 2021

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM 197 carrier protein. pneumoniae serotypes contained in the vaccine.

Immune Response 52

Immune Response Vaccination Vaccine FDA Approval 52

The Pharma Data

JANUARY 25, 2021

The AD-SAB will work closely with NervGen as the Company plans its upcoming preclinical studies and clinical trials and in the analyses of the results from these studies. The Company is developing drugs for the treatment of multiple sclerosis, spinal cord injury and Alzheimer’s disease. Inhibition of the PTP?

Clinical Development 40

Clinical Development Containment Development Research 40

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Sanofi, Empowering Life.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

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. For more info, please visit abingworth.com.

Development 52

Development Life Science Protein Clinical Development 52

The Pharma Data

SEPTEMBER 8, 2020

More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. About AstraZeneca. AstraZeneca.

Vaccination 52

Vaccination Vaccine Containment Clinical Trials 52

The Pharma Data

DECEMBER 2, 2020

Hemophilia is a genetic hematological rare disease that results in a deficiency of a protein that is required for normal blood clotting—clotting factor VIII in hemophilia A and clotting factor IX in hemophilia B. PFIZER DISCLOSURE NOTICE: The information contained in this release is as of November 23, 2020. About the BASIS study.

Containment 52

Containment Development Clinical Trials Clinical Trials 52

The Pharma Data

DECEMBER 20, 2020

In the first study, a phase 1/2 ‘basket’ trial of GPS in combination with the checkpoint inhibitor pembrolizumab (Keytruda), which is conducted under a Clinical Trial Collaboration and Supply Agreement with Merck & Co., The trial is currently evaluating patients with ovarian cancer (second or third line).

Life Science 52

Life Science Immune Response Trials Clinical Trials 52

The Pharma Data

OCTOBER 19, 2020

“Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. About Pneumococcal Disease.

Vaccination 52

Vaccination Vaccine Immune Response Containment 52

The Pharma Data

JANUARY 15, 2021

In the DESTINY-Gastric01 trial, patients (n=126) in the Enhertu treatment arm had a 41% reduction in the risk of death versus patients (n=62) treated with chemotherapy (based on a hazard ratio [HR] of 0.59; 95% confidence interval [CI] 0.39-0.88; Regular approval by the U.S. months [95% CI 9.6-14.3] months [95% CI 6.9-10.7] with chemotherapy.

Medicine 52

Medicine Trials Antibody HR 52

The Pharma Data

NOVEMBER 20, 2020

The increase in survival observed with Zokinvy was derived from two open-label clinical trials (N=62) conducted at Boston Children’s Hospital. We are extremely grateful to all the children, young adults and their families who have made this possible through participation in the Zokinvy clinical trials.”

FDA Approval 52

FDA Approval Genetics Clinical Trials Clinical Trials 52

The Pharma Data

NOVEMBER 30, 2020

The lead candidate, HTL0022562, has advanced through preclinical development demonstrating promising and differentiated properties for further investigation in human trials. We look forward to working on this new collaboration with Biohaven, a world leader in the clinical development of CGRP-targeted therapies.”

Licensing 40

Licensing Licensing Production Development 40

The Pharma Data

OCTOBER 30, 2020

30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

SEPTEMBER 1, 2020

.–( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). of participants in the trial, respectively.

Trials 52

Trials Clinical Trials Clinical Trials Vaccination 52

XTalks

DECEMBER 5, 2023

Augtyro, a tyrosine kinase inhibitor (TKI), is available as oral capsules, each containing 40 mg of repotrectinib. As its active ingredient, repotrectinib inhibits the proto-oncogene tyrosine-protein kinase ROS1 and the tropomyosin receptor tyrosine kinases (TRKs) TRKA, TRKB and TRKC. percent (95 percent CI: 46.2 percent, 79.2

Protein 115

Protein FDA Approval Medicine Trials 115

The Pharma Data

JUNE 26, 2021

The safety profile of PDS in the clinical trial setting is well understood and will continue to be closely monitored. Roche has a robust phase III clinical development programme underway for PDS, including the Portal, Pagoda and Pavilion studies. 9 Both the Pagoda and Pavilion trials are actively recruiting participants.

Drug Delivery 52

Drug Delivery Clinical Trials Clinical Trials Medicine 52

The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

Antibody 40

Antibody Production Trials Medicine 40