XTalks

JANUARY 29, 2021

This is relevant for clinical trials as more regulators require evidence of efficacy in comparison to the standard of care, which is likely to be one of the blockbuster products. This means that sponsors are having to fork out for these blockbuster products in order to run their trials more often.

Clinical Trials 104

Clinical Trials Clinical Trials Production Trials 104

Pharmaceutical Technology

JULY 29, 2022

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease.

Trials 264

Trials Clinical Trials Clinical Trials Licensing 264

XTalks

JUNE 20, 2022

Alnylam’s Onpattro was its first licensed and approved RNAi therapy for ATTR polyneuropathy. Hereditary ATTR has an autosomal dominant pattern of inheritance and is caused by point mutations in the transthyretin ( TTR ) gene that codes for the transthyretin transport protein found in the plasma and cerebrospinal fluid.

FDA Approval 98

FDA Approval Protein Genetics RNA 98

Drug Discovery World

AUGUST 9, 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Aleta Biotherapeutics a clinical trial authorisation (CTA) to evaluate biologic ALETA-001 in a Phase I/II clinical trial in patients with B-cell malignancies who are relapsed/refractory to CD19 CAR T cell therapy.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Licensing 52

pharmaphorum

JANUARY 18, 2022

Cancer Research UK’s Centre for Drug Development, working with the Ludwig Institute for Cancer Research and Vaccitech, has begun a phase I/IIa clinical trial of a new lung cancer vaccine. Vaccitech and the Ludwig Institute are providing the drug while the Centre manages the trial and provides funding.

Clinical Trials 62

Clinical Trials Clinical Trials Trials Vaccination 62

pharmaphorum

JUNE 16, 2022

The litany of failed trials of amyloid-targeting drugs for Alzheimer’s disease has added another verse, as Roche concedes that its crenezumab candidate was unable to slow cognitive decline in patients with an inherited form of the disease.

Trials 103

Trials Clinical Trials Clinical Trials Licensing 103

Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers advanced small protein therapies such as abicipar, a designed ankyrin repeat protein-based anti-angiogenic drug developed for diabetic macular edema and wet age- macular degeneration.

Protein 100

Protein Clinical Trials Clinical Trials Development 100

Pharmaceutical Technology

MARCH 1, 2023

Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The company offers advanced small protein therapies such as abicipar, a designed ankyrin repeat protein-based anti-angiogenic drug developed for diabetic macular edema and wet age- macular degeneration.

Protein 100

Protein Clinical Trials Clinical Trials Development 100

The Pharma Data

JANUARY 6, 2021

CAMBRIDGE, England & WETHERBY, England–( BUSINESS WIRE )– Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer ® and pre|CISION platforms, is pleased to announce that it has entered into a license agreement with POINT Biopharma Inc.

Licensing 52

Licensing Licensing Development Clinical Trials 52

Pharmaceutical Technology

MARCH 23, 2023

Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics. Adcetris is currently active in multiple clinical trials, including the ECHELON-3 Phase lll study for patients with relapsed or refractory diffuse large B-cell lymphoma.

Licensing 147

Licensing Licensing Sales Trials 147

The Pharma Data

MARCH 31, 2023

AstraZeneca has completed an exclusive global license agreement with KYM Biosciences Inc. CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive CMG901 is currently being evaluated in a Phase I trial for the treatment of Claudin 18.2-positive and consists of an anti-Claudin 18.2

Licensing 40

Licensing Licensing Antibody Drugs 40

pharmaphorum

MARCH 23, 2021

Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts. . The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis.

Trials 82

Trials Licensing Licensing Protein 82

Roots Analysis

FEBRUARY 27, 2024

Currently, product licensing agreements, technology licensing agreements, research and development agreements and clinical trial agreements are the common types of partnerships inked by developers that are currently focused on the development of ADCs pipeline.

Antibody 52

Antibody Licensing Licensing Contract Manufacturing 52

Drug Discovery World

AUGUST 12, 2022

Pfizer has launched a Phase III clinical trial of a vaccine to protect people against Lyme disease, in collaboration with pharmaceutical company Valneva. . The trial will enrol up to 6,000 participants aged five years and older and will be conducted across 50 sites where Lyme disease is highly endemic. Juan Carlos Jaramillo M.D.,

Vaccination 52

Vaccination Vaccine Trials Bacteria 52

Pharmaceutical Technology

SEPTEMBER 22, 2022

AVR-RD-04 works by genetically modify a patient's hematopoietic stem cells (HSCs) to express the gene that encodes the cystinosin protein. Cystinosis patients have a high deficiency of this protein. A rare and fatal ailment, cystinosis is characterised by cystine buildup in cellular organelles called lysosomes.

Gene Therapy 147

Gene Therapy Gene Protein Clinical Trials 147

Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. C5 is a protein that is involved in the activation of the complement system.

Antibody 130

Antibody FDA Approval Licensing Licensing 130

The Pharma Data

JULY 22, 2021

(NYSE: PFE) today announced a global collaboration to develop and commercialize ARV-471, an investigational oral PROTAC® (PROteolysis TArgeting Chimera) estrogen receptor protein degrader. The estrogen receptor is a well-known disease driver in most breast cancers. Chief Executive Officer at Arvinas. Terms of the Collaboration.

Protein 52

Protein Development HR Hormones 52

Drug Discovery World

MARCH 24, 2023

Efti As a first-in-class soluble LAG-3 protein targeting MHC Class II ligands on antigen-presenting cells (APC), efti is positioned to improve clinical outcomes from standard-of-care chemotherapy. Its activation of APCs (e.g., The first patient is expected to be enrolled early in the second quarter of the 2023 calendar year.

Trials 52

Trials Immune Response HR Clinical Development 52

The Pharma Data

NOVEMBER 3, 2020

The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to fund development of a potential COVID-19 vaccine from China’s Clover Biopharmaceuticals with a global phase 2/3 study and through licensing and distribution. million for an initial trial of SCB-2019 in Australia that enrolled 150 participants.

Vaccination 52

Vaccination Vaccine Trials Licensing 52

Pharmaceutical Technology

AUGUST 14, 2022

KMFDS granted the approval based on findings from a paediatric expansion of Phase III PREVENT-19 clinical trial underway to analyse the safety, immunogenicity and efficacy of the vaccine. . Tenderness/pain at the site of injection, headache, fatigue, myalgia and malaise was seen to be the most common adverse reactions in the trial. .

Vaccination 147

Vaccination Vaccine Clinical Trials Clinical Trials 147

The Pharma Data

OCTOBER 27, 2021

NYSE and TASE: TEVA) and MODAG GmbH today announced a strategic collaboration on the exclusive worldwide licensing and development of MODAG’s lead compound anle138b and a related compound, sery433. synuclein protein, mainly in oligodendroglial cells (glial cytoplasmic inclusions) and also in certain nerve cells.

Licensing 52

Licensing Licensing Drugs Development 52

pharmaphorum

NOVEMBER 6, 2020

Novartis’ Ilaris (canakinumab) has failed to produce results in a phase 3 trial, which tested whether it could improve COVID-19 patients’ survival chances without need for mechanical ventilation. The key secondary endpoint was to reduce the COVID-19-related death rate during the four week period after trial treatment.

Trials 40

Trials Genetic Engineering Licensing Licensing 40

The Pharma Data

DECEMBER 2, 2020

This License Agreement represents an important corporate milestone. The License provides EYAM with the exclusive right to develop several proprietary COVID-19 vaccine candidates in a self-amplifying mRNA vaccine platform. EYAM anticipates rapid commencement of animal trials for these COVID-19 vaccine candidates.

Licensing 52

Licensing Licensing Vaccination Vaccine 52

Pharmaceutical Technology

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The human monoclonal antibody denosumab has been designed to bind to osteoclasts activator, RANKL protein.

Packaging 130

Packaging Packaging Medicine Licensing 130

The Pharma Data

JANUARY 11, 2021

a San Diego-based biotechnology company with an array of technology platforms for antibody discovery and optimization, and novel NK and T cell engager generation, today announced licensing of a panel of its anti-SARS-CoV-2 antibody clones to IGM Biosciences for COVID-19 therapy development.

Antibody 52

Antibody Licensing Licensing Development 52

Delveinsight

JANUARY 12, 2021

Medivir, IGM Biosciences enters into an exclusive licensing agreement for Birinapant. Medivir AB has entered into an exclusive licensing agreement with IGM Biosciences to receive global, exclusive development rights for Birinapant. million after Birinapant successfully becomes a part of the Phase I trials.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

Pharmaceutical Technology

AUGUST 23, 2022

It comprises messenger ribonucleic acid (mRNA) that encodes for the initial spike protein of SARS-CoV-2 along with mRNA that encodes for Omicron BA.4/BA.5 5 variant spike protein. According to pre-clinical findings, a booster dose of this vaccine elicited a robust neutralising antibody response against the variants Omicron BA.1,

Vaccination 130

Vaccination Vaccine Gene Therapy Protein 130

pharmaphorum

FEBRUARY 11, 2021

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial. . The vaccine stimulated antibodies against the protein in all 32 patients with early-stage AD in the study at levels that AC Immune thinks should have a therapeutic effect.

Antibody 127

Antibody Protein Vaccination Vaccine 127

Pharmaceutical Technology

JANUARY 23, 2023

Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021. However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years.

Marketing 278

Marketing Production Drugs Trials 278

XTalks

APRIL 3, 2024

The RBCs in circulation are marked by proteins in the complement system for removal by the spleen and liver. Voydeya’s FDA approval was based on positive results from the pivotal ALPHA Phase III trial. In the trial, the most common adverse events were headache, nausea, arthralgia (joint stiffness) and diarrhea.

FDA Approval 102

FDA Approval Sales Trials Development 102

pharmaphorum

DECEMBER 2, 2021

Novartis has licensed a potential drug for Parkinson’s from Belgium’s UCB that it thinks could be the first oral, disease-modifying drug for the disease – if it can avoid the fate of earlier drugs in the class. The Swiss group is paying $150 million upfront for co-development rights to UCB0599 in a deal that could be worth $1.5

Antibody 95

Antibody Licensing Licensing Gene Therapy 95

pharmaphorum

JUNE 17, 2021

Tau is a protein that is found in cells of the central nervous system and is involved in the assembly and stabilisation of neuronal microtubules – channels used to transport substances to different parts of the nerve cell. In Alzheimer’s, the protein runs amok, forming tangles that have been linked to cell damage and neuronal death.

Antibody 98

Antibody Protein Licensing Licensing 98

XTalks

JULY 17, 2023

protein on the surface of gastric epithelial cells, which display abnormal expression levels of this protein compared to normal cells. Phase III Clinical Trials Underpinning the Applications The applications are grounded on two Phase III clinical trials, SPOTLIGHT and GLOW. How Does Zolbetuximab Work?

Clinical Trials 95

Clinical Trials Clinical Trials Trials Antibody 95

Drug Discovery World

MARCH 6, 2024

Earlier last year the biotech successfully led a second round of investment, taking the total up to £13.2m ($16.7m), which will take it up to the start of in-human clinical trials later this year. With the toxic protein suppressed, other proteins step in to help form normal myelin.

Drugs 52

Drugs Protein Gene Clinical Trials 52

pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion.

Antibody 82

Antibody Drugs Protein Licensing 82

The Pharma Data

MARCH 11, 2021

Clinical trial to assess safety, immune response and reactogenicity, after preclinical data showed high neutralizing antibody levels. The Companies expect interim results from this trial in the third quarter of 2021. MRT5500 is being developed under a collaboration and license agreement between Sanofi Pasteur and Translate Bio.

Clinical Trials 52

Clinical Trials Clinical Trials Vaccination Vaccine 52

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76