Drug Discovery World

JUNE 21, 2024

Allogene Therapeutics and Foresight Diagnostics have announced the initiation of a Phase II trial evaluating the use of cemacabtagene ansegedleucel (cema-cel) as part of the first line treatment regimen for newly diagnosed large B-cell lymphoma (LBCL) patients who are likely to relapse.

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Science Daily: Pharmacology News

SEPTEMBER 2, 2024

Finerenone reduced the composite of total first and recurrent heart failure (HF) events (hospitalizations for HF or urgent HF visits) and cardiovascular death in patients with HF and mildly reduced or preserved ejection fraction, according to an international clinical trial.

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Drug Discovery World

DECEMBER 12, 2023

Exonate, an mRNA therapy company focused on treatments for diabetic complications, has announced that its lead ophthalmology asset, EXN407, has achieved its prespecified endpoints in a Phase Ib/IIa study. During the trial, EXN407 met all safety and pharmacokinetic parameters and displayed encouraging signals of biological activity.

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Drug Discovery World

JULY 25, 2023

In participants with MDD, the trial will also assess rapid onset of antidepressant effect on the day of dosing, using the Montgomery-Asberg Depression Rating Scale and evaluate the incremental benefit of a second dose of CYB003 when administered in week three.

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Drug Discovery World

DECEMBER 1, 2022

Based on Nakhoda and Olszanski, 2022 (Addressing Recent Failures in Immuno-Oncology Trials to Guide Novel Immunotherapeutic Treatment Strategies), lack of an optimal biomarker is one of the main challenges to clinical trial success. Director, Application Development, LevitasBio will present the event. Camila Egidio.

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Drug Discovery World

MARCH 15, 2024

All doses were well-tolerated and there were no serious adverse events. The post Early trial data supports neurodegenerative disease-modifying drug appeared first on Drug Discovery World (DDW). ALX-001 achieved high exposure and successfully characterised a wide safety window at all doses, which ranged from 50mg to 150mg.

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Drug Discovery World

NOVEMBER 1, 2023

However, it was associated with higher rates of grade ≥3 cytokine release syndrome and neurological events. Datopotamab deruxtecan, Daiichi Sankyo and AstraZeneca The companies shared results from multiple trials of their TROP2 directed DXd antibody drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd). Median PFS was 13.8

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Drug Discovery World

JUNE 23, 2023

PTC518 treatment was also demonstrated to be well tolerated, with no treatment-related serious adverse events, no reports of peripheral neuropathy or dose-limiting toxicities. The post Positive interim data from Huntington’s disease trial appeared first on Drug Discovery World (DDW).

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Drug Discovery World

JANUARY 26, 2024

He will go on to discuss the company’s move to Phase I clinical trials with a drug targeting Fragile-X Syndrome, a leading cause of autism and intellectual disabilities. See the full programme and register now to show your interest in attending this event.

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Drug Discovery World

APRIL 12, 2023

Evecxia Therapeutics has reported favourable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase I trial of EVX-101 in healthy volunteers treated with escitalopram. Details of the trial In EVX-101, the 5-HTP dose is fixed at 250mg, while variable levels of carbidopa control 5-HTP plasma exposure levels.

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Drug Discovery World

MARCH 13, 2024

Johnson & Johnson has announced the first data from FRONTIER 2, the long-term extension of the Phase IIb FRONTIER 1 clinical trial evaluating JNJ-2113, the first and only investigational targeted oral peptide designed to block the IL-23 receptor. at 16 weeks and 76.2% Across JNJ-2113 treatment groups, 58.6%

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Drug Discovery World

AUGUST 22, 2023

Bloom Science has announced positive topline data from a Phase I clinical trial of BL-001 , a potential first-in-class therapeutic the company is developing for Dravet syndrome and amyotrophic lateral sclerosis (ALS).

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Drug Discovery World

JUNE 21, 2023

Moreover, there were no reported significant adverse events and CITI-002 was well tolerated by patients in the study. Following the 21 st Century Cures Act, higher emphasis is placed on using Patient Reported Outcome (PRO) instruments in clinical trials.

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Advarra

OCTOBER 1, 2024

Managing clinical trial budgets efficiently is necessary for the success and sustainability of clinical research sites. Effective budget management not only ensures trials are financially viable but also maximizes return on investment (ROI). the impact and value of the data produced).

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Drug Discovery World

SEPTEMBER 8, 2023

The first quadruplex-edited, allogeneic CAR-T cell therapy candidate has entered clinical trials in the US. The primary objectives of the Phase I portion of the trial are the assessment of safety, tolerability, and identification of the recommended Phase II dose and lymphodepletion regimen.

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Drug Discovery World

JUNE 15, 2023

A Phase I clinical trial testing a CAR-T cell therapy treatment in children with acute myeloid leukaemia (AML) has been paused due to a patient’s death. The PLAT-08 clinical trial is a Phase I study of 2seventy bio’s cell therapy SC-DARIC33 in patients with AML.

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PPD

AUGUST 7, 2024

Clinical trials are the backbone of medical research, enabling the development of new treatments and therapies that can improve patient outcomes. However, conducting successful clinical trials requires efficient communication and coordination among various stakeholders. This is where contact center services play a vital role.

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Drug Discovery World

APRIL 10, 2023

RESP-X, Infex Therapeutics’ anti-virulence therapy to treat Pseudomonas aeruginosa (Pa) infections in non-cystic fibrosis bronchiectasis (NCFB) patients, has shown a promising interim safety and tolerability profile in its ongoing first-in-human Phase I clinical trial.

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Drug Discovery World

NOVEMBER 9, 2023

These new positive qEEG results further advance our confidence in dose selection and our understanding of how this novel class of molecules achieves rapid and durable effects through event-driven pharmacology,” said Mike McCully, CEO of Gate Neurosciences. “We

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PPD

JUNE 24, 2024

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19.

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Drug Discovery World

MARCH 15, 2023

The primary endpoint has been achieved in a Phase II trial of AP30663, a first-in-class SK ion channel inhibitor for conversion of atrial fibrillation (AF) to normal sinus rhythm. Acesion Pharma enrolled 63 patients with a current episode of AF in the trial and tested two intravenous doses of AP30663, 3 and 5mg/kg, compared to placebo.

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Drug Discovery World

JULY 19, 2023

The primary endpoint of iADRS measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events. This is the first Phase III trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.”

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ProRelix Research

FEBRUARY 12, 2023

Historical events such as the sulfanilamide elixir tragedy that resulted in the mass poisoning and the deaths of hundreds of patients in the 1930s and the thalidomide scandal which caused […] The post Clinical Trial Regulations in the United States appeared first on ProRelix Research.

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PPD

AUGUST 28, 2024

For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy. This is why oncology trials must be built around patient needs, and sponsors need to balance the complexity of oncology trials with a patient-centric mindset. Many of these patients’ conditions are disabling.

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Conversations in Drug Development Trends

AUGUST 29, 2024

By: Nathan Chadwick, Therapeutic Strategy Lead, Rare Disease Over the last few years in clinical trials, particularly within the rare disease community, a notable shift is underway, where patients and caregivers are taking the lead in reaching out to clinical trial sites rather than the other way around.

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Drug Discovery World

SEPTEMBER 16, 2024

The authors found that T cell malignancies represented a small minority of adverse events at just 1.5%. CAR-T adverse events To understand the frequency and subtypes of SPMs following CAR-T in lymphoma and myeloma, the authors of the new study conducted a literature search in the MEDLINE, Embase, and CENTRAL (Cochrane) databases.

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Drug Discovery World

AUGUST 23, 2024

A new study indicates that anti-obesity drug semaglutide helps prevent cardiac events among overweight people who have cardiovascular disease, even if they also have heart failure. whose hearts did not pump blood around the body properly) by a clinician at the start of the trial.

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Drug Discovery World

JULY 12, 2023

Primary and secondary safety and efficacy endpoints include the rate of adverse and serious adverse events and the improvement in diuretic response (measured as a six-hour urine sodium output) from baseline through the end of the treatment period. Following four weeks of treatment, there is a three-month safety follow-up period.

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PPD

OCTOBER 9, 2023

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. Patient centricity has become more than a key consideration.

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Quanticate

APRIL 12, 2024

The landscape of clinical research is undergoing major changes with virtual clinical trials driving these transformations. These innovative trials promise to revolutionise the way medical research is conducted, making it more accessible, efficient, and patient-centric than ever before.

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Drug Discovery World

SEPTEMBER 27, 2024

The approval of Quviviq, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data including from a dedicated Japanese Phase III trial. The rate of adverse events was comparable between placebo and daridorexant at both treatment doses. for placebo).

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Drug Discovery World

SEPTEMBER 12, 2022

Chaired by Karin Blumer, Director of Global Patient Engagement at Novartis, the first event in this track, called ‘Patient Engagement: Driving Patient Advocacy to Inform Patient Centric Development’, looked into the multi-layered importance of involving patients in the drug development process, particularly in this case for gene therapy.

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Antidote

JUNE 27, 2024

In case you missed it, we’re sharing some of our key takeaways from the four-day event, which focused on charting new horizons in clinical trials. Not only was it a lovely opportunity to connect with many industry professionals and learn from experts, but it was also the celebration of 60 years of DIA.

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Vial

JUNE 24, 2024

Contract research organizations (CROs) and pharmaceutical companies can leverage these cutting-edge technologies to streamline clinical trials and introduce automation in drug discovery. As clinical trials grow in complexity, the volume of data being gathered and utilized for these studies is expanding.

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Alta Sciences

MAY 10, 2024

Outsourcing in Clinical Trials Southern California iianiro Fri, 05/10/2024 - 19:02 Image pic.jpg Synopsis San Diego, CA Tags Clinical Trials URL [link] Event End Date Wed, 09/25/2024 - 12:00 Event Start Date Tue, 09/24/2024 - 12:00 Weight 1

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Quanticate

MARCH 11, 2024

Clinical trials although methodically planned, can hit unexpected roadblocks steering them off course. From resource shortages and unforeseen service needs to contractual issues, recruitment problems and adverse events, these challenges can bring even the most carefully planned trials to a grinding halt.

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Drug Discovery World

SEPTEMBER 3, 2024

Semaglutide, which is approved for diabetes (as Ozempic) and obesity (as Wegovy), has been hailed as a miracle drug, found to reduce the risk of cardiovascular events and cancer. Of the 833 deaths in trial participants, 58% were CV related, and 42% were non-CV related. on semaglutide vs 3.1% on placebo).

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