Pharmaceutical Technology

APRIL 7, 2023

The approval came with a condition that a confirmatory clinical trial should be undertaken to evaluate the predicted clinical benefit to newborns. The results of the trial neither reduced preterm births nor demonstrated any improvement in the health of newborn babies.

Drugs 243

Drugs FDA Approval Clinical Trials Clinical Trials 243

ACRP blog

JULY 20, 2022

Along with MSM, the Yale School of Medicine and Vanderbilt University Medical Center have launched “ Equitable Breakthroughs in Medicine Development ,” an “historic” collaboration designed to increase diversity in clinical trials and address systemic barriers to participation in them by communities of color, Rice said.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Medicine 98

ACRP blog

MAY 8, 2024

Nobody ever said that clinical research would be easy. Monair McGregor, PhD, MPH, MCHES, Community Engagement Program Manager for SiteBridge Research Inc.; I’m blessed to be working in a company that values community engagement so much that it has its own department” for it, said McGregor, who is based in North Carolina. “We

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

Pharmaceutical Technology

APRIL 7, 2023

The approval came with a condition that a confirmatory clinical trial should be undertaken to evaluate the predicted clinical benefit to newborns. The results of the trial neither reduced preterm births nor demonstrated any improvement in the health of newborn babies.

Drugs 239

Drugs FDA Approval Clinical Trials Clinical Trials 239

Pharmaceutical Technology

APRIL 27, 2023

Vowst is an orally administered microbiota-based therapeutic, previously known as SER-109, and is indicated for the prevention of recurrence of CDI in people aged 18 years and above following an antibacterial treatment for recurrent CDI (rCDI).

FDA Approval 246

FDA Approval Regulation Trials Development 246

Rethinking Clinical Trials

AUGUST 23, 2022

There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. The Duke Clinical Research Institute (DCRI) organized and sponsored a Think Tank to address diversity in clinical trial research.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Medicine 130

Rethinking Clinical Trials

OCTOBER 31, 2023

Advancing Rural Back Pain Outcomes through Rehabilitation Telehealth (ARBOR-Telehealth) is a pragmatic trial that seeks to understand the effectiveness of telerehabilitation as a method of improving access to physical therapy for patients with chronic lower back pain living in rural communities and improving outcomes of these patients.

Trials 154

Trials Nurses Clinical Trials Clinical Trials 154

Rethinking Clinical Trials

JANUARY 17, 2024

UPMC did not allow patients to receive experimental COVID-19 therapies outside of the context of a clinical trial and used the REMAP-CAP platform, a global pragmatic adaptive trial platform, in all clinic sites. UPMC set clear criteria based on the published data at the time for who could and could not receive Remdesivir.

Clinical Trials 173

Clinical Trials Clinical Trials Antibody Trials 173

XTalks

FEBRUARY 21, 2024

Black participation in clinical trials, and the underrepresentation of minority groups in general in trials, remains low. It is therefore important to work towards increasing Black participation in clinical trials, which begins with understanding the barriers to participation and taking steps to address them.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Life Science 59

ACRP blog

APRIL 29, 2024

Every May 20th, our community celebrates Clinical Trials Day. It was on this day in 1747 when Dr. James Lind conducted what is largely considered to be the first clinical trial, testing different treatments for scurvy among sailors aboard a ship and reliably proving the therapeutic solution of vitamin C.

Clinical Trials 59

Clinical Trials Clinical Trials Trials Clinical Research 59

XTalks

SEPTEMBER 27, 2023

Colorectal cancer, the third most frequently diagnosed cancer for both women and men in the US, continues to be a significant area of focus for the medical community. As advancements in research forge ahead, it is imperative to ensure patients are informed about and can access potentially life-saving clinical trials.

Clinical Trials 111

Clinical Trials Clinical Trials Trials Research 111

Rethinking Clinical Trials

DECEMBER 18, 2023

Ethics and regulatory onboarding documentation for 2 of the NIH Pragmatic Trials Collaboratory's newest trials is now available. ARBOR-Telehealth will evaluate the use of a telehealth physical therapy strategy for patients who present to primary care clinics with low back pain in rural communities.

Clinical Trials 130

Clinical Trials Clinical Trials Trials 130

ACRP blog

JUNE 27, 2022

Sponsors hoping to increase minority participation in clinical trials might want to cast a wider net when looking for community-based site partners, says Liz Beatty, chief strategy officer at Inato. The keys to success for promoting diversity in clinical trials are “time, trust, and respect,” Beatty says.

Clinical Trials 85

Clinical Trials Clinical Trials Trials Vaccination 85

Rethinking Clinical Trials

FEBRUARY 28, 2024

            Speakers Adrian Hernandez, MD Executive Director, Duke Clinical Research Institute Vice Dean, Duke University School of Medicine Christopher J. The global decentralized clinical trial market is expected to grow at a compound annual growth rate of 30.1% from 2021 to 2026. I think we must.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Clinical Research 143

Pharmaceutical Technology

APRIL 26, 2023

Biogen president and CEO Christopher Viehbacher stated: “For more than a decade, Biogen has been steadfast in our commitment to pursuing treatments for ALS, and I want to thank the scientists as well as the entire ALS community who have all worked tirelessly to bring this first-of-its-kind treatment to people with SOD1-ALS.

Genetics 130

Genetics Trials Protein Gene 130

Pharmaceutical Technology

AUGUST 25, 2022

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

JUNE 7, 2023

“We look forward to making this important treatment available to the paediatric oncology community in the EU as soon as possible.” The CHMP’s opinion was based on the findings obtained from two randomised, open-label, pivotal Phase III trials (SIOPEL 6 and clinical oncology group [COG] protocol ACCL0431).

Marketing 130

Marketing Medicine Trials Production 130

Drug Discovery World

APRIL 4, 2024

EnteroBiotix, a Glasgow, UK based biotechnology company, has dosed the first patient in a clinical trial designed to evaluate EBX-102-02 for the treatment of irritable bowel syndrome (IBS). The trial will be delivered in partnership with the Functional Gut Clinic, a leading IBS diagnosis and treatment centre.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Drugs 98

Pharmaceutical Technology

MAY 18, 2023

Ardelyx’s resubmitted NDA is based on a comprehensive development programme that enrolled over 1,200 patients in three Phase III trials assessing the safety and efficacy of XPHOZAH. The PHREEDOM, BLOCK and AMPLIFY trials all met their primary and key secondary endpoints.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Regulation 130

Rethinking Clinical Trials

JULY 18, 2023

Lynn DeBar and Dr. Natalia Morone In an interview at the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting, Dr. Lynn DeBar and Dr. Natalia Morone had a conversation about sharing trial results with participant partners. Community advisory boards can provide a wealth of information.

Trials 130

Trials Research Packaging Packaging 130

Worldwide Clinical Trials

NOVEMBER 10, 2023

At this year’s annual Pain Therapeutics Summit , which took place in San Diego, CA, October 19 to 20th, I heard brilliant presentations on novel pain medication development, targeted discoveries, pain classifications, the NIH HEAL Initiative , trial designs, biomarkers, and others. As mentioned, these are but a few topics for contemplation.

Clinical Trials 184

Clinical Trials Clinical Trials Trials Compliance 184

pharmaphorum

FEBRUARY 8, 2022

Glasgow, UK (24th November, 2021) – Formedix , a leading provider of clinical trial software solutions, announces the launch of the Formedix ryze Community, to provide their customers with a location to collaborate, expand their knowledge and share information. 30 seconds Intro to the Community. “We

Clinical Trials 87

Clinical Trials Clinical Trials Trials Production 87

Pharmaceutical Technology

APRIL 12, 2023

“HyQvia is now available to a broader community impacted by PI, including children and their families with distinct needs, who may prefer flexible treatment options in the management of these disorders.” This was a primary endpoint of the trial. HyQvia was found to be effective as a treatment for acute serious bacterial infections.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Containment 130

Rethinking Clinical Trials

AUGUST 18, 2022

The initiative will support pragmatic, implementation, and hybrid effectiveness-implementation trials that study strategies for equitably and efficiently implementing effective interventions and evidence-based pain management guidelines in rural and remote communities.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Trial Funding 130

Pharmaceutical Technology

MAY 11, 2023

“This approval is the culmination of extensive work and collaboration with the NMOSD community, including patients, caregivers and healthcare providers who participated in the CHAMPION-NMOSD trial, and we’re proud to continue improving access to our innovative medicines worldwide.”

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Scienmag

JUNE 16, 2022

June 16, 2022 — Toronto — The Ontario Institute for Cancer Research (OICR) is announcing funding for three new Ontario-based clinical trials as part of its Window-of-Opportunity (WOO) Network.

Clinical Trials 78

Clinical Trials Clinical Trials Trials Research 78

ACRP blog

JANUARY 17, 2024

Today, large academic research centers receive the vast majority of trial opportunities, leaving countless other sites constrained by studies that don’t align with their strengths. I am optimistic that the tides are turning in the clinical trial ecosystem. New tech solutions, coupled with heightened U.S.

Trials 59

Trials Clinical Trials Clinical Trials Research 59

Rethinking Clinical Trials

OCTOBER 11, 2023

Through this initiative, 7 Clinical Centers are expected to test an evidence-based, multi-level intervention designed to reduce or eliminate cardiovascular and/or pulmonary health disparities. They also helped review each Clinical Center’s protocol before it went to the DSMB and NHLBI for transition to the UH3 phase.

Clinical Trials 154

Clinical Trials Clinical Trials Trials Research 154

pharmaphorum

DECEMBER 1, 2022

Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.

Clinical Trials 109

Clinical Trials Clinical Trials Trials Clinical Research 109

Pharmaceutical Technology

JANUARY 12, 2023

It has been approved to treat NSCLC patients with EGFR Exon20 insertion mutations, whose disease has advanced on or after they received platinum-based chemotherapy. Takeda stated that the complete approval of Exkivity for the indication might be dependent on the clinical benefit verification in a confirmatory trial.

Trials 130

Trials Medicine Production Development 130

pharmaphorum

NOVEMBER 17, 2022

By working directly with each distinct community, made up of people with a certain neurological variance, their families, supporters, and advocates, it is easier to gather different perspectives and address unmet needs. The first step is recognising that within many neurological conditions, the community is diverse.

Clinical Research 83

Clinical Research Research Clinical Trials Clinical Trials 83

Pharmaceutical Technology

APRIL 27, 2023

CHMP’s positive opinion is based on solid results from the Phase III SUNSHINE and SUNRISE identical, global, multicentre, randomised, double-blind, placebo-controlled, parallel-group trials for HS. Data from both trials were submitted to the US Food and Drug Administration, which expects to give its decision later this year.

Medicine 130

Medicine Trials Production Marketing 130

Rethinking Clinical Trials

JUNE 27, 2023

Anne Trontell and Ana Quiñones A focus of the 2023 NIH Pragmatic Trials Collaboratory Annual Steering Committee Meeting was health equity in embedded pragmatic clinical trials (ePCTs). Networks such as the NIA IMPACT Collaboratory and the NIH Pragmatic Trials Collaboratory have an important role to play in these efforts as well.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

XTalks

NOVEMBER 30, 2023

Every December 1, the global community comes together to observe World AIDS Day. The World Health Organization (WHO) has designated the theme of World AIDS Day 2023 as “Let Communities Lead.” The FDA’s endorsement of Sunlenca is backed by compelling clinical evidence, demonstrating its efficacy as a viable treatment option.

FDA Approval 111

FDA Approval Gene Therapy Clinical Trials Clinical Trials 111

XTalks

APRIL 24, 2024

National Minority Health Month, observed annually throughout April, serves to emphasize the recognition of the unique health challenges faced by minority communities. There is a need for more research program support and clinical trials.

Research 105

Research Allergies Clinical Trials Clinical Trials 105

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

Vaccination 293

Vaccination Vaccine Antibody Trials 293

Pharmaceutical Technology

MARCH 27, 2023

“The approval and near-term launch of Joenja, our second commercial product, brings us closer to our goal of becoming a leading global rare disease company dedicated to patient communities with unmet medical needs.” The findings showed the clinical efficacy of a 70mg Joenja dosage given twice-a-day.

FDA Approval 130

FDA Approval Clinical Trials Clinical Trials Medicine 130