Drug Target Review

DECEMBER 13, 2024

2 Unmet needs in lung cancer treatment Recent decades have seen significant advancements in lung cancer treatment, especially with the introduction of targeted therapies and immunotherapies, which have notably improved survival rates. 15 Figure 1: A schematic illustrating a bispecific antibody-drug conjugate (ADC).

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Codon

NOVEMBER 3, 2024

In the 1924 novel, The Magic Mountain , Thomas Mann describes a sanatorium patient named Anton Ferge as he undergoes a painful tuberculosis (TB) treatment. A 1994 review of 14 prospective trials and 12 case-control studies revealed that the BCG vaccine reduced the risk of TB by 50 percent. million people every year.

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PPD

OCTOBER 31, 2024

From adapting to complex new trial designs to embracing cutting-edge technologies, staying ahead requires a deep understanding of the current landscape. Drug development The rising cost of clinical trials is the top challenge this year, due to increasingly complex protocol designs and difficult patient recruitment.

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Broad Institute

NOVEMBER 7, 2023

While RA therapies targeted to specific inflammatory pathways have emerged, only some patients’ symptoms improve with treatment, emphasizing the need for multiple treatment approaches tailored to different disease subtypes. They also found that patients’ CTAPs were dynamic and could change over time in response to treatment.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Authors: Matt Cooper, PhD, Executive Director, Therapeutic Strategy Lead, Oncology; Megan Morrison, Vice President, Asia Pacific Strategy Lead Adaptive trial designs have become essential in oncology, offering a flexible and efficient approach for conducting clinical trials.

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Advarra

MARCH 6, 2025

For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.

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PPD

DECEMBER 16, 2024

Cost and complexity go hand-in-hand The rising costs and growing complexity in clinical trials are deeply linked, with patient recruitment, extended timelines and meeting regulatory demands emerging as some of the key drivers. Nearly half (49%) of clinical trial sponsors surveyed identified rising costs as their foremost concern in 2024.

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Drug Patent Watch

DECEMBER 9, 2024

This includes: Preclinical studies Clinical trials Regulatory approval Manufacturing and marketing Throughout this process, pharmaceutical companies seek to protect their investments through patents. The development of Taxol involved multiple patents, including those for the isolation method, synthetic production, and various formulations.

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Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. Additionally, clinical trials are no longer confined to one country or region.

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Common Sense for Drug Policy Blog

APRIL 21, 2024

Agonist Treatment for Cannabis Use Disorder "Cannabinoid agonist treatment is unlikely to be an approach relevant to all cannabis users seeking treatment, as evidenced by the large numbers of individuals who did not complete the study screening process, and the modest 12-week treatment retention rates. JAMA Intern Med.

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The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. ADUHELM is indicated for the treatment of Alzheimer’s disease.

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The Pharma Data

DECEMBER 1, 2020

Rapid and substantialimprovement in depressive symptoms achieved by 44% of patients at 2 weeks, 67% at 6 weeks (MADRS response), and sustained with long-term treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. points at Week 6 (primary timepoint), with AXS-05 treatment. NEW YORK, Dec.

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On Medicine

MAY 17, 2023

When health research is published, we tend to focus our minds on the findings and consider the implications for future treatments. Yet, what about those who took part in the trial? In recent years there has been an increasing call to let trial participants know the results of trials in which they have taken part.

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The Pharma Data

JANUARY 17, 2021

Aruvant has chosen Lonza to help develop and manufacture ARU-1801 for its upcoming pivotal trial. “Our internal cell therapy process expertise combined with Lonza’s cell processing know-how provide the perfect combination to manufacture ARU-1801 for our pivotal study. . NEW YORK , Jan.

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The Pharma Data

AUGUST 30, 2021

Late-breaking abstract highlights a network meta-analysis on monthly migraine day reductions with AJOVY, Nurtec ® ODT (Rimegepant) and Atogepant in the preventive treatment of episodic migraine. Time Gained With Long-term Fremanezumab Treatment in Patients With Chronic and Episodic Migraine. TEL AVIV, Israel & PARSIPPANY, N.J.–(BUSINESS

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The Pharma Data

DECEMBER 30, 2020

Long-term safety profile consistent with previously completed controlled trials. Treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. Axsome remains on track to submit an NDA for AXS-07 in the acute treatment of migraine in the first quarter of 2021.

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Vial

JUNE 12, 2024

PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? From a regulatory standpoint, agencies like the U.S. These aspects influence a patient’s perceived health-related quality of life (QoL).

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The Pharma Data

SEPTEMBER 9, 2021

(NYSE and TASE: TEVA), today announced results from a network meta-analysis examining the efficacy of AJOVY (fremanezumab-vfrm), atogepant and Nurtec ® ODT (rimegepant) in the preventive treatment of episodic migraine (EM). 8-12, 2021. Atogepant 60 mg BID. a 1-12 weeks; 9-12 weeks for Rimegepant. b Exact value with 3 decimal places: ?0.004.

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Drug Target Review

DECEMBER 11, 2024

By employing advanced analytical techniques like high-resolution mass spectrometry (HRMS) and carefully calibrating systems with optimal internal standards (IS), we effectively mitigate matrix effects and provide reliable preclinical toxicology data. These solutions must contain analytes and internal standards at known concentrations.

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The Pharma Data

SEPTEMBER 6, 2021

The primary efficacy outcome was met showing a statistically significant reduction in the 24-hour cough count (average hourly cough frequency based on 24-hour sound recordings) of up to 27% for eliapixant 75 mg twice daily over placebo after 12 weeks of treatment.

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H1 Blog

JULY 19, 2023

Food and Drug Administration (FDA) issued draft guidance, Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics , regarding clinical trial design specific to oncology with considerations to support accelerated approval applications.

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Advarra

JUNE 20, 2023

Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community. More targeted therapies may change which patients and cancers may benefit, since a given treatment may only impact very specific biomarkers and genetic profiles.

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The Pharma Data

AUGUST 30, 2021

Approval marks an important transformation in the treatment of more than 13 million people suffering from chronic kidney disease in Japan. The approval by Japan’s Ministry of Health, Labour and Welfare (MHLW) is based on positive results from the DAPA-CKD Phase III trial. 2-4 The condition affects 840 million people worldwide.

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Vial

JUNE 18, 2024

The success of clinical trials hinges on increasing access to participation by all eligible patients, including populations that have been underrepresented due to the barriers highlighted below. Representation, Underrepresentation & Diversity in Clinical Trials Studies indicate a need to increase patient accessibility to clinical trials.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. galactosidase-A product candidate under development for the treatment of Fabry disease. Twenty of twenty-two patients completed the 12-month treatment duration. CARMIEL, Israel and BOSTON , Dec.

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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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Clinical Trials Trials Compliance Laboratories 52

Conversations in Drug Development Trends

DECEMBER 12, 2022

Genetic testing provides patients with a diagnosis for their illness, helps patients and family members to understand risks of developing new diseases, and can be used to support clinical trial advancement. Can prior genetic testing results be utilized in a trial, or should a new genetic sample be taken before participating?

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Olympian Clinical Research

SEPTEMBER 3, 2020

Eating a well balanced diet, full of fruits and vegetables, floods your body with antioxidants that then decrease the internal inflammation contributing to and/or caused by depression. . We just started a clinical trial to explore a new treatment option for patients who suffer from moderate to severe depression.

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Drug Target Review

FEBRUARY 16, 2024

This could lead to more precise treatment for patients with cancers like oesophageal, breast, ovarian and endometrial, which solves an unmet need to discover genetic abnormalities that predict ICB responses in these tumour types. Now, the team are developing and standardising their test and algorithm further for clinical use.

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The Pharma Data

JANUARY 11, 2021

-based subsidiary of Terumo and a global neurovascular company, announced today the FDA Approval of the PMA Supplement for the WEB 17 System, a new addition to the WEB Aneurysm Embolization System for the treatment of intracranial wide neck bifurcation aneurysms. The WEB System received its first PMA approval in late 2018.

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The Pharma Data

JANUARY 6, 2021

The ongoing coronavirus pandemic and the lack of treatment options for severe cases has been devastating for patients, their families and medical communities around the world,” commented Erik van den Berg , Chief Executive Officer at AM-Pharma. I am excited to continue our collaboration with AM-Pharma for this trial.”.

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The Pharma Data

NOVEMBER 18, 2021

– CHALLENGE-MIG is the first and only clinical trial comparing two anti-calcitonin gene-related peptide (CGRP) medicines, Emgality and Nurtec ODT, which work differently – The study’s primary endpoint is the percentage of patients with ?50% 75% and 100% reductions from baseline in monthly migraine headache days.

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Treatment Clinical Trials Trials Disease 52

The Pharma Data

JANUARY 14, 2021

PRA Health Sciences selected for the study which will position Awakn at the Forefront of Psychedelic Research for Addiction Treatment. While there are current treatment methods available, which are effective for some segments of the population, relapse rates are high. ” About Awakn Life Sciences. About PRA Heath Sciences.

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The Pharma Data

JANUARY 20, 2021

Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.

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The Pharma Data

NOVEMBER 27, 2020

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma. the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. NEW YORK, Nov.

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The Pharma Data

AUGUST 31, 2021

The randomised, active-controlled global trial will enrol around 4,000 participants from a range of countries and will aim to evaluate GBP510’s safety and immunogenicity compared to an active comparator – the AstraZeneca/Oxford University COVID-19 vaccine. GSK commitment to tackling COVID-19.

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