pharmaphorum

SEPTEMBER 4, 2020

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. If trials go well the companies could request regulatory approval in the first half of 2021. Sanofi is leading the clinical development and registration of the COVID-19 vaccine.

Clinical Trials 106

Clinical Trials Clinical Trials Vaccination Vaccine 106

pharmaphorum

DECEMBER 16, 2020

AbbVie is to begin clinical development of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinical trial of the antibody, with clinical development beginning in the US and expanding into Europe.

Antibody 98

Antibody Trials Licensing Licensing 98

XTalks

JANUARY 17, 2024

They discussed the top new trends in oncology trial design that sponsors are either incorporating into clinical trials or need to start planning to include. There were a range of therapies under discussion, from targeted therapies to advanced antibody-drug conjugates (ADCs) and cell and gene therapies,” he says.

Clinical Trials 124

Clinical Trials Clinical Trials Trials Gene Therapy 124

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

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

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.

Antibody 130

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.

Antibody 130

Antibody Engineer FDA Approval Development 130

XTalks

DECEMBER 10, 2024

Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5 The LUNA 3 study enrolled 202 adults with persistent or chronic ITP and severely low platelet counts, averaging just 15,000 per microliter well below the normal range of 150,000 to 450,000 per microliter.

Trials 104

Trials Protein Clinical Development Drugs 104

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

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

XTalks

JANUARY 22, 2025

seroresponse rate indicating the proportion of participants achieving antibody levels above a predefined protective threshold sustained one year after vaccination. One year post-vaccination, antibody levels remained strong, with geometric mean titers well above the required protective threshold. The findings reveal a remarkable 98.3%

Immune Response 59

Immune Response Vaccination Vaccine Trials 59

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

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

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.

Antibody 100

Antibody Protein Clinical Development Manufacturing 100

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.

Trials 101

Trials Clinical Trials Clinical Trials Antibody 101

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.

Antibody 52

Antibody Clinical Trials Clinical Trials Medicine 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

VirTrial

JUNE 17, 2024

Over the past decades, Myasthenia Gravis (MG) clinical trials have made remarkable progress in shining a light on this debilitating disease. Clinical trials in MG – What does history tell us? With a better understanding of the disease mechanisms, new target treatment options emerged in the 20th century.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Antibody 52

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.

FDA Approval 66

FDA Approval Bacteria DNA Bacterium 66

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.

Antibody 100

Antibody Engineer Development Drugs 100

Pharmaceutical Technology

FEBRUARY 19, 2023

AT-1412 is under clinical development by Kling Biotherapeutics and currently in Phase I for Solid Tumor. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. It acts by targeting cells expressing CD9 epitope.

Antibody 100

Antibody Clinical Trials Clinical Trials Development 100

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.

Insulin 100

Insulin Antibody Clinical Trials Clinical Trials 100

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.

Insulin 100

Insulin Antibody Clinical Trials Clinical Trials 100

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

The Pharma Data

NOVEMBER 25, 2020

26, 2020 /PRNewswire/ — Cantargia AB (OMXS: CANTA) and BioInvent International AB (OMXS: BINV), today announced that BioInvent has been contracted as manufacturer of Cantargia’s antibody CAN10 in preclinical development for the treatment of systemic sclerosis and myocarditis. LUND, Sweden , Nov. About Cantargia.

Antibody 52

Antibody Manufacturing Clinical Trials Clinical Trials 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

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.

FDA Approval 105

FDA Approval Antibody Drugs Clinical Trials 105

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. percent in the 68-week STEP-1 clinical trial.

Trials 104

Trials Drugs Clinical Trials Clinical Trials 104

Pharmaceutical Technology

JUNE 5, 2023

Izokibep is under clinical development by Acelyrin and currently in Phase II for Panuveitis. 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 affibody technology.

Antibody 100

Antibody Development Clinical Trials Clinical Trials 100

Pharmaceutical Technology

FEBRUARY 19, 2023

Annexuzlimab is under clinical development by MedAnnex and currently in Phase I for Kidney Cancer (Renal Cell Cancer). 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.

Antibody 100

Antibody Clinical Trials Clinical Trials Drugs 100

The Pharma Data

AUGUST 7, 2020

The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinical trials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinical trials to combat Covid-19.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

The Pharma Data

NOVEMBER 30, 2020

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. pivotal Phase 3 trial update. Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K.

Clinical Development 52

Clinical Development Vaccination Vaccine Development 52

Pharmaceutical Technology

FEBRUARY 28, 2023

MCLA-129 is under clinical development by Merus and currently in Phase II for Esophageal Squamous Cell Carcinoma (ESCC). 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.

Antibody 100

Antibody Development Drugs Clinical Trials 100