Pharmaceutical Technology

FEBRUARY 6, 2023

It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy. These anti-pCTS-L monoclonal antibodies may help in providing effective treatments for human sepsis as well as other infectious diseases, such as Covid-19.

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Protein Research Antibody Immune Response 263

STAT News

AUGUST 3, 2022

An experimental antibody treatment prevented malaria in the majority of participants in a small but important new study , providing a measure of hope in the effort to lower the burden of the disease worldwide. Read the rest…

Antibody 105

Antibody Clinical Trials Clinical Trials Trials 105

Pharmaceutical Technology

OCTOBER 18, 2022

Gilead Sciences has entered an exclusive option and partnership agreement with MacroGenics for developing bispecific antibodies. MGD024 is an investigational bispecific antibody that attaches to CD123 and CD3. The post Gilead partners with MacroGenics for bispecific antibody development appeared first on Pharmaceutical Technology.

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Antibody Development Sales Clinical Trials 130

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

Pharmaceutical Technology

JANUARY 13, 2023

Being co-developed and co-marketed by Daiichi Sankyo along with AstraZeneca , Enhertu is a specifically engineered HER2-directed antibody-drug conjugate (ADC). Enhertu’s safety profile was consistent with the previous clinical trials.

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HR Trials Engineer Clinical Trials 321

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.

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Clinical Trials Clinical Trials Trials Gene Therapy 124

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. Furthermore, Enhertu’s safety profile was in line with prior clinical trials without any new safety concerns detected. Enhertu-treated subjects had a median overall survival (OS) of 23.4

FDA Approval 264

FDA Approval HR Clinical Trials Clinical Trials 264

Pharmaceutical Technology

NOVEMBER 20, 2022

This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK. At the time Amanda Pritchard, chief executive of NHS England, doubled down on the issue of medicine access. “If

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Drugs Medicine Antibody Clinical Trials 279

Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March.

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Vaccine Vaccination Immune Response Antibody 277

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

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

AUGUST 15, 2022

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. 1) versus the 50µg mRNA-1273 booster dose. 1 variant as well as the original 2020 strain.”.

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Vaccine Vaccination Immune Response Clinical Trials 214

Pharmaceutical Technology

DECEMBER 18, 2022

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting variation to the marketing authorization (MA) for Moderna ’s Spikevax bivalent Original/Omicron BA.1 Additionally, the application included findings from a Phase II/III clinical trial of mRNA-1273.214.

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Gene Therapy Vaccine Vaccination Clinical Trials 304

Medical Xpress

APRIL 19, 2023

A treatment combining two antibodies against the coronavirus SARS-CoV-2 strongly protected high-risk people with early COVID-19 symptoms from hospitalization and death in an international Phase 2/3 clinical trial conducted in the first half of 2021 and co-led by researchers at Weill Cornell Medicine and NewYork-Presbyterian.

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Antibody Trials Clinical Trials Clinical Trials 95

Pharmaceutical Technology

OCTOBER 31, 2022

Actemra is claimed to be the first humanised interleukin-6 receptor-antagonist monoclonal antibody which received approval from Health Canada for intravenous and subcutaneous administration in rheumatoid arthritis. Actemra remains a part of national and international guidelines for therapy.

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Clinical Trials Clinical Trials Antibody Regulation 264

Pharmaceutical Technology

JUNE 29, 2022

The treatment has maintained orphan medicinal product designation for this indication. 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.

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Gene Therapy Clinical Trials Clinical Trials Genetics 278

Pharmaceutical Technology

FEBRUARY 3, 2023

Being jointly developed by AstraZeneca and Amgen, Tezspire is a first-in-class human monoclonal antibody and inhibits TSLP, an important epithelial cytokine that plays a vital role in multiple inflammatory cascades. Asthma control improvement and safety profile were consistent with previous clinical trials.

FDA Approval 147

FDA Approval Antibody Clinical Trials Clinical Trials 147

Scienmag

APRIL 21, 2021

Credit: NIAID A Phase 2/3 trial to evaluate a new fully-human polyclonal antibody therapeutic targeted to SARS-CoV-2, called SAB-185, has begun enrolling non-hospitalized people with mild or moderate cases of COVID-19.

Antibody 81

Antibody Clinical Trials Clinical Trials Trials 81

Scienmag

APRIL 13, 2021

Credit: NIAID A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19, has begun.

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Antibody Trials Clinical Trials Clinical Trials 93

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. Check out this webinar on navigating the landscape of oncology clinical trials. Interested in hearing more insights from Matt?

Antibody 162

Antibody Clinical Trials Clinical Trials In-Vitro 162

XTalks

DECEMBER 12, 2023

Plasma medicine is a critical and specialized field within healthcare, centering on the use of human plasma for the development and administration of life-saving treatments. Human plasma, the clear, liquid portion of blood, is composed of water, electrolytes, nutrients and crucial proteins such as antibodies, clotting factors and albumin.

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Medicine Recombinant Antibody Protein Antibody 111

Pharmaceutical Technology

MAY 19, 2023

In a January presentation, the company shared that approvals in additional indications would allow Rinvoq and Skyrizi, a monoclonal antibody, to gain peak share in the different markets, including inflammatory bowel disease. In patients with severe symptoms, a dosage of 30mg can be considered.

FDA Approval 264

FDA Approval Dermatology Sales Clinical Trials 264

pharmaphorum

MARCH 24, 2022

There’s a rich history of finding useful medicines from fungi, from the antibiotic penicillin to immune suppressant cyclosporine and cholesterol drug lovastatin. The examples remain few and far between, however, as in recent decades the pharma industry has turned its attention to synthetic molecules and biologics like antibodies.

Medicine 105

Medicine Genome Genomics Engineer 105

pharmaphorum

SEPTEMBER 16, 2020

Regeneron’s COVID-19 antibody cocktail has been added to the UK’s RECOVERY trial, one of the largest of its kind in the world that is testing several potential coronavirus therapies at the same time. REGN-COV2 is a combination of two monoclonal antibodies, designed to block infections of SARS-CoV-2, the virus that causes COVID-19.

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Antibody Trials Manufacturing Protein 98

Scienmag

JUNE 27, 2022

A major clinical trial, led by experts at the University of Nottingham working in partnership with several Universities and NHS hospitals, has found that by interrupting the treatment of vulnerable people on long-term immune supressing medicines for two weeks after a COVID-19 booster vaccination, their antibody response to the jab is doubled.

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Antibody Medicine Vaccine Vaccination 60

Medical Xpress

DECEMBER 22, 2022

A weekly dose of dupilumab, a monoclonal antibody, led to a reduction of symptoms and tissue improvement in young adults and adolescents with eosinophilic esophagitis (EoE), according to a new study published in the New England Journal of Medicine.

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Antibody Allergies Clinical Trials Clinical Trials 75

XTalks

FEBRUARY 12, 2025

XTALKS WEBINAR: Overcoming Challenges in Clinical Trial Completion Live and On-Demand: Wednesday, March 19, 2025, at 10:30am EDT (3:30pm CET/EU-Central) Register for this free webinar to transform challenges into opportunities and optimize the crucial final stages of clinical trials.

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Clinical Trials Clinical Trials Trials FDA Approval 66

Pharmaceutical Technology

JANUARY 16, 2023

AstraZeneca has announced that its Tezspire (tezepelumab) received approv al from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in the EU for self-administration in severe asthma patients aged 12 years and above.

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Clinical Trials Clinical Trials Trials Medicine 147

XTalks

NOVEMBER 7, 2022

Gleich, MD, FACS, Senior Vice President, Medical Department, and Dr. Christopher Huth, PhD, Senior Clinical Trial Manager, Clinical Trial Management. Liquid Biopsy Use in Oncology Clinical Trials. FoundationOne ® Liquid CDx (Foundation Medicine; end-to-end commercial provider).

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Clinical Trials Clinical Trials Trials FDA Approval 98

XTalks

AUGUST 22, 2022

Blueprint Medicines announced top-line results from their clinical trial of Ayvakit (avapritinib) in patients with non-advanced systemic mastocytosis (SM) that showed clinically meaningful and highly significant improvements. What Were the Results from the PIONEER Clinical Trial?

Medicine 98

Medicine Clinical Trials Clinical Trials Trials 98

Worldwide Clinical Trials

MAY 30, 2024

Authors: Rich Worldwide Clinical Trials Exec. This trend is on the rise despite recent disappointments with clinical trial outcomes, which have the potential to destabilize the industry in the short term regarding drug development strategy and optimal study designs. Director, Therapeutic Area Medical Lead.

Gene 204

Gene Clinical Trials Clinical Trials Gene Therapy 204

pharmaphorum

OCTOBER 12, 2022

Genomic medicine is a rapidly growing space in which researchers use the information in a person’s genes to identify and administer medical treatment.”. The evolving field of genomic medicine. There are two components to genomic medicine, known as the payload and the vector. Forging an AI-enabled path toward precision medicine.

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Genomics Genome Medicine Development 105

Pharmaceutical Technology

APRIL 28, 2023

Therini Bio will use part of the funds to advance its potential first-in-class investigational antibody, THN391, into clinical trials. This funding will enable us to accelerate the development of our lead antibody programme targeting inflammatory fibrin in neurodegenerative and retinal diseases. “We

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Development Immune Response Clinical Trials Clinical Trials 130

Pharmaceutical Technology

NOVEMBER 7, 2022

The latest approval in the EU is based on findings from Beyfortus's clinical development programme, including the Phase III MELODY, Phase II/III MEDLEY and Phase IIb clinical trials. Additionally, Beyfortus was found to have a safety and tolerability profile in line with Synagis (palivizumab) in the MEDLEY trial.

Clinical Trials 162

Clinical Trials Clinical Trials Trials Medicine 162

Pharmaceutical Technology

APRIL 4, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for AstraZeneca ’s Ultomiris (ravulizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients.

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Marketing Clinical Trials Clinical Trials Trials 130

XTalks

APRIL 1, 2025

Related: Niktimvo (Axatilimab) Approved as First-in-Class Therapy for Chronic GVHD More on Itolizumabs Clinical Data Itolizumab is a humanized anti-CD6 monoclonal antibody that targets the CD6-ALCAM pathway involved in T cell activation and trafficking. The risk limits the number and type of patients who receive HSCT.

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Immune Response Trials Licensing Licensing 94

XTalks

DECEMBER 10, 2024

Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5 percent platelet response in a study published in The New England Journal of Medicine. This aligns with previous studies, reinforcing its potential as a well-tolerated treatment option.

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Trials Protein Clinical Development Drugs 104