Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

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Immune Response Clinical Trials Clinical Trials Antibody 273

Worldwide Clinical Trials

OCTOBER 14, 2024

Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide Clinical Trials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.

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Research Clinical Trials Clinical Trials Immune Response 130

XTalks

JANUARY 21, 2025

The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca.

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Pharmaceutical Technology

APRIL 14, 2023

Clinical-stage biopharmaceutical company TORL BioTherapeutics has raised $158m in a Series B financing round for advancing the development of new biologics for cancer treatment. TORL BioTherapeutics is a newly formed, US-based company focused on the development of novel antibody-based therapeutics for cancer patients. CLDN 18.2).

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Development Clinical Trials Clinical Trials Life Science 264

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

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Antibody Drugs Clinical Development Licensing 130

Pharmaceutical Technology

AUGUST 22, 2022

The World Health Organization (WHO) has made new recommendations for the usage of two monoclonal antibodies to treat the Ebola virus in its first published guideline. mAb114 (Ansuvimab; Ebanga) and REGN-EB3 (Inmazeb) are the two monoclonal antibody treatments recommended by the WHO.

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Antibody Clinical Trials Clinical Trials Trials 147

XTalks

APRIL 11, 2025

Jobevne, like Avastin, is a humanized monoclonal antibody that blocks vascular endothelial growth factor (VEGF). By preventing VEGF from binding its receptors on blood vessel linings, the drug cuts off tumors oxygen and nutrient supply. Bevacizumab biosimilars rank among the top-selling oncology drugs in India.

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Antibody Marketing Clinical Trials Clinical Trials 104

pharmaphorum

NOVEMBER 6, 2022

The potential of monoclonal antibodies (mAbs) as therapies is indisputable. In 2021, five out of the top 10 selling drugs were mAbs and this trend is forecasted to remain the same over the next five years. Artificial Intelligence (AI) and deep learning have already transformed several aspects of small molecule drug design.

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Antibody Drugs Protein Life Science 123

XTalks

MAY 2, 2022

This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). The main pathological markers of AD are beta-amyloid (A?)

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Clinical Trials Clinical Trials Antibody Trials 98

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Lecanemab is an amyloid antibody that targets oligomers and protofibrils of amyloid.

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Pharmaceutical Technology

AUGUST 24, 2022

The global immunotherapy market, which includes CAR T-cell therapy, adoptive cell therapies, checkpoint inhibitors, monoclonal antibodies, and other immunotherapies, is expected to grow by 10.1% Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies.

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Clinical Trials Clinical Trials Trials Development 130

XTalks

DECEMBER 4, 2024

In this episode, Ayesha spoke with John Yu, MD, CEO of Kairos Pharma , a company advancing therapies to overcome challenges in cancer drug resistance and immune suppression. Kairos is developing therapeutics that reverse cancer drug resistance in cancers such as prostate and lung cancer. Dr. Yu has also led numerous clinical trials.

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Drugs Life Science Clinical Trials Clinical Trials 59

XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense. It’s very positive and it’s going to help move forward the pathway for new drugs.”

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Medical Xpress

NOVEMBER 21, 2022

Over the past two decades, numerous complex cancer therapies called antibody drug conjugates (ADCs) have been tested in clinical trials and approved for use in patients. Their findings are published online in Cancer.

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Antibody Drugs Clinical Trials Clinical Trials 97

Pharmaceutical Technology

SEPTEMBER 16, 2022

The US Food and Drug Administration (FDA) has granted fast track designation to Jasper Therapeutics’ antibody, JSP191, for the treatment of severe combined immunodeficiency (SCID) patients who undergo allogeneic hematopoietic stem cell transplant. .

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Antibody Clinical Trials Clinical Trials Licensing 130

Pharmaceutical Technology

DECEMBER 7, 2022

Last week, the quest for an effective Alzheimer’s disease therapy received a notable fillip at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference 2022, with new data on Eisai’s disease-modifying therapy lecanemab. Lecanemab is an amyloid antibody that targets oligomers and protofibrils of amyloid.

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Development Drugs Clinical Trials Clinical Trials 246

Bio Pharma Dive

AUGUST 20, 2024

In addition to new stock offerings, this week saw Merck license an antibody drug conjugate and BARDA further work trying to innovate remote clinical trials.

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Clinical Trials Clinical Trials Licensing Licensing 143

Pharmaceutical Technology

NOVEMBER 14, 2022

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FR?)-positive, binding antibody, a cell-surface protein which is greatly expressed in ovarian cancer, as well as the maytansinoid payload DM4.

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Antibody FDA Approval Clinical Trials Clinical Trials 246

Pharmaceutical Technology

AUGUST 12, 2022

The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. In the trial, 1.9% According to the interim efficacy data from a pre-specified patient cohort, a 5.4

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Pharmaceutical Technology

JUNE 2, 2023

Briumvi is an anti-CD20 monoclonal antibody indicated for RMS adult patients with active disease which is defined by clinical or imaging features. It has been engineered to remove certain sugar molecules generally expressed on the antibody. The therapy targets a unique epitope on CD20-expressing B-cells.

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STAT News

DECEMBER 11, 2022

NEW ORLEANS — An antibody treatment developed by the Belgian drugmaker Argenx raised platelet counts and stopped bleeding episodes in patients with a rare autoimmune disorder that causes the body to attack and destroy its own blood-clotting platelets.

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Antibody Clinical Trials Clinical Trials Drugs 105

Bio Pharma Dive

MAY 9, 2022

Ameet Mallik takes over for founder Chris Martin at helm of the antibody drug developer after a seven-month run leading Rafael Holdings, which reported a clinical trial setback last October.

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Clinical Trials Clinical Trials Antibody Trials 154

Pharmaceutical Technology

NOVEMBER 18, 2022

The US Food and Drug Administration (FDA) has approved Provention Bio’s biologics licence application (BLA) for Tzield (teplizumab-mzwv) to treat type 1 diabetes (T1D) patients. The anti-CD3-directed antibody Tzield aims to delay the onset of Stage 3 T1D in adults and children aged eight years and above who are currently with stage 2 T1D.

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FDA Approval Clinical Trials Clinical Trials Antibody 246

XTalks

APRIL 22, 2022

Flow cytometric receptor occupancy assays are being increasingly used in preclinical and clinical studies. Both the areas of drug development and clinical trials are increasingly using in vitro assays to help determine the efficacy of an investigational therapeutic. What is Flow Cytometry?

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Clinical Trials Clinical Trials Trials Antibody 98

STAT News

JANUARY 10, 2023

SAN FRANCISCO — For months, drugmakers have been pleading with regulators to lower the bar for authorizing antibody drugs for Covid. The virus, they noted, had evolved fast enough to render every previous antibody obsolete.

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Antibody Clinical Trials Clinical Trials Regulation 98

STAT News

NOVEMBER 13, 2022

Roche reported negative results Monday from a pair of clinical trials investigating an antibody treatment for people with early-stage Alzheimer’s disease — another setback for the Swiss pharma giant’s decades-long effort to develop medicines against the memory-destroying disease.

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Clinical Trials Clinical Trials Trials Antibody 98

Worldwide Clinical Trials

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

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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

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

Medical Xpress

APRIL 10, 2023

Repeat radiation therapy combined with the monoclonal antibody drug bevacizumab extended progression-free survival in patients with recurrent glioblastoma, according to findings from a recent clinical trial published in the Journal of Clinical Oncology.

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Clinical Trials Clinical Trials Trials Antibody 75

Pharmaceutical Technology

DECEMBER 7, 2022

Health Canada has granted approval for a supplement to a New Drug Submission (sNDS) of Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted), Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. The trial is designed to analyse the safety and effectiveness of the vaccine.

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Vaccination Vaccine Protein Clinical Trials 264

Pharmaceutical Technology

JANUARY 19, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for Avidity Biosciences’ AOC 1020 to treat facioscapulohumeral muscular dystrophy (FSHD). It comprises a monoclonal antibody (mAb) attached to the transferrin receptor 1 (TfR1) conjugated with a DUX4 mRNA that targets siRNA.

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Gene Expression Gene Protein RNA 246

Pharmaceutical Technology

JUNE 29, 2022

The latest approval is based on findings from the global, single-arm Phase II ZUMA-5 clinical trial in 122 relapsed or refractory FL patients. These subjects received a minimum of two lines of systemic therapy previously, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent.

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Worldwide Clinical Trials

SEPTEMBER 29, 2022

Preclinical assays designed to assess drug toxicity and safety must detect total drug. For studies of humanized therapeutics (monoclonal antibodies [mAb], fusion protein, antibody-drug conjugates [ADC], bispecific antibodies, etc.), anti-human IgG).

Reagent 130

Reagent Clinical Trials Clinical Trials Antibody 130

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has approved AbbVie’s Rinvoq (upadacitinib) for patients with Crohn’s disease who do not respond to TNF blockers, a common immune suppressant treatment for the condition. In patients with severe symptoms, a dosage of 30mg can be considered.

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FDA Approval Dermatology Sales Clinical Trials 264

pharmaphorum

APRIL 9, 2021

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The study was a key element of the FDA filing, and the first ever evidence that a drug therapy could delay the onset of T1D.

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