Pharmaceutical Technology

JUNE 9, 2023

Upstream Bio will use the funds to advance its UPB-101 into Phase II trials to treat asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). It is also preparing for a swift transition to Phase III development. It targets the human thymic stromal lymphopoietin receptor to inhibit signalling.

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Clinical Development Development Life Science Clinical Trials 147

XTalks

JUNE 4, 2024

In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinical trials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”

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Clinical Development Development Clinical Trials Clinical Trials 110

XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. The VLA1553-321 trial, conducted in Brazil, was the first to assess the vaccine in an endemic region. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

Pharmaceutical Technology

AUGUST 25, 2022

The treatment is indicated for patients with no history of Factor VIII inhibitors and any detectable antibodies to adeno-associated virus serotype 5 (AAV5). The approval is based on comprehensive data from the clinical development programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinical trial.

Gene Therapy 264

Gene Therapy Gene Clinical Trials Clinical Trials 264

Pharmaceutical Technology

MARCH 9, 2023

Global biopharmaceutical firm UCB and Cancer Research UK have entered a multi-project partnership to advance two of the former’s oncology antibody candidates through clinical trials. The clinical development partnership will focus on the development of UCB6114 and UCB4594 investigational antibody candidates.

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Antibody Research Clinical Trials Clinical Trials 130

Pharmaceutical Technology

APRIL 17, 2023

Pharmaceutical company Genmab is entering a partnership with argenx to develop antibody therapies for oncology and immunology. This collaboration is being made to combine the companies’ capabilities to develop novel therapeutic antibodies with applications in the two disease areas.

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Antibody Engineer FDA Approval Development 130

Pharmaceutical Technology

APRIL 13, 2023

FPI-2068 is a bispecific targeted alpha therapy (TAT) being jointly developed by Fusion and AstraZeneca under a multi-asset collaboration agreement. The therapy will be assessed in a Phase I trial. It will conduct the Phase I trial, while AstraZeneca will handle the subsequent clinical development of FPI-2068.

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Clinical Development Antibody Development Trials 147

XTalks

OCTOBER 23, 2024

Otsuka Pharmaceutical has announced positive interim results from its Phase III clinical trial for sibeprenlimab. Sibeprenlimab, which has a Breakthrough Therapy designation, is a monoclonal antibody that blocks APRIL ( A PR oliferation- I nducing L igand), a critical step in the immune cascade contributing to IgAN.

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Trials Clinical Trials Clinical Trials Antibody 101

Pharmaceutical Technology

OCTOBER 25, 2022

Additionally, Astellas will obtain an exclusive option for licencing two clinical-stage programmes of Taysha, namely TSHA-102 and TSHA-120, for Rett syndrome and GAN, respectively. Astellas will also receive specific rights linked to any possible change of Taysha’s control.

Gene Therapy 264

Gene Therapy Gene Development Genetics 264

pharmaphorum

SEPTEMBER 4, 2020

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. They said the trials would involve 440 adults at 11 sites across the US. If trials go well the companies could request regulatory approval in the first half of 2021.

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Clinical Trials Clinical Trials Vaccination Vaccine 106

XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight.

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Trials Drugs Clinical Trials Clinical Trials 104

Pharmaceutical Technology

MAY 9, 2023

FibroGen has signed an exclusive licence agreement with Fortis Therapeutics for the FOR46 antibody-drug conjugate (ADC) that targets a new epitope on CD46, a protein-coding gene. FOR46 is currently being investigated in a Phase I trial as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC).

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Drugs Clinical Development Antibody Protein 130

Pharmaceutical Technology

MAY 25, 2023

Apexigen discovers and develops a new generation of antibody therapeutics to treat cancer, along with new immuno-oncology products to harness the immune system to combat and eradicate cancer.

Antibody 130

Antibody Clinical Trials Clinical Trials Clinical Development 130

XTalks

JANUARY 17, 2024

Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

XTalks

DECEMBER 5, 2024

Amgen announced positive results from a Phase II clinical trial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight. “We

Trials 96

Trials Drugs Clinical Trials Clinical Trials 96

pharmaphorum

MARCH 15, 2022

Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinical trials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. Sanofi has partnered with drug delivery specialist Enable Injections to develop the subcutaneous formulation.

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Trials Sales Drug Delivery Antibody 97

Pharmaceutical Technology

APRIL 4, 2023

Merck stated that the regulatory approval represents the first of its kind received by an anti-PD-1 therapy in combination with an antibody-drug conjugate for use in targeted patients in the US. The trial was jointly conducted by Seagen and Astellas.

Antibody 130

Antibody Containment Clinical Development Trials 130

XTalks

DECEMBER 10, 2021

Biohaven Pharmaceuticals revealed positive top line results from a late-stage trial which show that its migraine medication Zavegepant provides “ultra-rapid” pain relief in just 15 minutes. Zavegepant is an antibody drug that prevents binding of the calcitonin gene-related peptide (CGRP) to the CGRP receptor.

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FDA Approval Trials Drugs Sales 98

XTalks

APRIL 15, 2025

Clinical Trial Results Blujepas approval was based on data from the Phase III EAGLE-2 and EAGLE-3 trials that enrolled over 3,000 patients. In both studies, Blujepa demonstrated non-inferiority to the current standard-of-care, nitrofurantoin, in achieving clinical and microbiological resolution.

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FDA Approval Bacteria DNA Bacterium 66

BioPharma Reporter

OCTOBER 27, 2020

The clinical research solutions firm is joining forces with pharma giant Eli Lilly to manage mobile research of the monoclonal antibody LY-CoV555.

Research 98

Research Antibody Clinical Research Trials 98

BioPharma Reporter

JULY 12, 2021

Antibody responses against the SARS-CoV-2 spike protein were found in 99% of volunteers after the second dose of ReiTheraâs COVID-19 vaccine candidate, according to Phase 2 preliminary data.

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Vaccination Vaccine Protein Antibody 105

pharmaphorum

NOVEMBER 16, 2021

Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with an oral alternative. In another 14-day trial involving men and women, MK-0616 reduced LDL cholesterol by around 65% from baseline when it was added to background therapy with statins.

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Trials Drugs Sales Clinical Trials 98

Pharmaceutical Technology

MAY 2, 2023

Pamrevlumab, a human monoclonal antibody targeting connective tissue growth factor, is currently undergoing clinical trials for the treatment of conditions including idiopathic pulmonary fibrosis, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer and Duchenne muscular dystrophy.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Development Antibody 130

Pharmaceutical Technology

AUGUST 11, 2022

The proceeds from the business combination will be utilised to advance the pipeline of Disc to clinical trials and offer funding into 2025. Disc focuses on discovering and developing new therapies for patients with serious haematologic ailments. In-licensed from AbbVie in 2019, DISC-0974 is a monoclonal antibody.

Medicine 147

Medicine Clinical Trials Clinical Trials Licensing 147

Pharmaceutical Technology

FEBRUARY 19, 2023

STRO-002 is under clinical development by Sutro Biopharma and currently in Phase I for Refractory Acute Myeloid Leukemia. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.

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Antibody Protein Clinical Development Manufacturing 100

XTalks

MAY 9, 2024

Genmab, a trailblazer in the field of antibody therapeutics, celebrates this milestone by reflecting on its impressive journey from a small-scale startup to a global leader in cancer treatment and beyond. Since then, innovative science has been at Genmab’s core, as we harness the power of human antibodies to improve the lives of patients.

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Antibody Clinical Trials Clinical Trials Medicine 52

Pharmaceutical Technology

FEBRUARY 24, 2023

Amlitelimab is under clinical development by Kymab and currently in Phase II for Asthma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. It is developed based on Kymouse technology.

Antibody 100

Antibody Clinical Trials Clinical Trials Drugs 100

XTalks

APRIL 2, 2025

Fordyce founded Vera in 2016 as an entrepreneur in residence at Kleiner Perkins Caufield and Byers, took the company public in 2021 and has advanced its lead molecule through a successful Phase II trial in IgA nephropathy. Along the way, Dr. Fordyce has built a world class team of drug developers and raised over $1 billion in capital.

Life Science 59

Life Science Clinical Development Development Trials 59

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Metastatic Adenocarcinoma of The Pancreas. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is administered through intravenous drip route.

Antibody 100

Antibody Engineer Development Drugs 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Gastric Cancer. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. The therapeutic candidate is a bispecific antibody targeting CD3 and claudin 18.2

Antibody 100

Antibody Engineer Development Drugs 100

Pharmaceutical Technology

FEBRUARY 25, 2023

ASP-2138 is under clinical development by Xencor and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It is administered through intravenous drip route.

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Antibody Engineer Development Drugs 100

The Pharma Data

NOVEMBER 30, 2020

Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. In alignment with Novavax’ commitment to transparency, Phase 3 clinical trial protocols are posted to the company’s website at Novavax.com/resources upon finalization.

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Clinical Development Vaccination Vaccine Development 52

pharmaphorum

MAY 20, 2021

Switzerland’s Numab has raised 100 million Swiss francs – around $110 million – in Series C financing to develop bispecific antibodies for cancer and inflammation, with Novo Noldings and HBM Partners co-leading the investor syndicate. The post Numab raises $110m to develop cancer bispecific antibodies appeared first on.

Antibody 52

Antibody Development Clinical Development Life Science 52

Worldwide Clinical Trials

JULY 8, 2024

With radiopharmaceuticals emerging as a diagnostic and therapeutic (theranostics) procedure, many are in the clinical development pipeline and are expected to play a crucial role in the future of healthcare. Whether you’re considering a new study or need support with an ongoing trial, we’re here to partner with you.

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Hormones Regulation Clinical Trials Clinical Trials 130

Pharmaceutical Technology

MARCH 23, 2023

Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics.

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Licensing Licensing Sales Trials 147

XTalks

JANUARY 6, 2025

However, some patients develop inhibitors antibodies that neutralize the efficacy of replacement therapies. Alhemo is a bispecific monoclonal antibody that mimics the function of factor VIII without requiring direct replacement of the missing factor. After a five-month suspension, Novo resumed the studies.

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FDA Approval Antibody Drugs Clinical Trials 105

Pharmaceutical Technology

JUNE 10, 2023

RZ-358 is under clinical development by Rezolute and currently in Phase II for Hyperinsulinemia. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It was also under development for the treatment of insulinomas.

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Insulin Antibody Clinical Trials Clinical Trials 100