Drug Discovery World

JULY 1, 2024

Following a trip to Copenhagen, Denmark, DDW’s Megan Thomas reflects on the Novo Nordisk Foundation’s efforts to tackle cardiometabolic diseases. The World Health Organization (WHO) reports that cardiovascular diseases (CVDs) are the leading cause of death globally, stating that an estimated 17.9

Disease 162

Disease International Research Science 162

Olympian Clinical Research

SEPTEMBER 3, 2020

The tough thing about depression is that the disease is wildly indiscriminate, affecting patients of every age, gender, and ethnicity. For patients that struggle with depression, the disease can have devastating impacts both mentally, physically, and emotionally. Sleep is especially important in regulating mood.

Clinical Trials 98

Clinical Trials Treatment Clinical Research Trials 98

Drug Discovery World

APRIL 14, 2023

He is being recognised for his revolutionary contributions to developing the first gene-edited cell-based therapy for cancer that involves the genetic re-engineering of a patient’s own T cells to combat their disease, and for demonstrating that adoptive T-cell therapy can induce remission and in some cases cure patients with advanced cancer.

Clinical Trials 130

Clinical Trials Research Science Clinical Research 130

Drug Discovery World

SEPTEMBER 28, 2022

Whilst we know that AI has been effective in practices such as validating targets that may be suitable to treat a disease, it faces a plethora of significant challenges. Which areas of drug discovery research stand to benefit most? . But has its application been as revolutionary as industry bods predicted? . The simple answer is no.

Pharma Companies 130

Pharma Companies Hospitals Clinical Trials Drugs 130

The Pharma Data

NOVEMBER 10, 2020

P otential to be a safer and effective alternative to the intravenous immunotherapies currently used for Crohn’s Disease. Crohn’s Disease Therapeutics Market Size $4.7 Phase1b/2 clinical study to be conducted in the United States and several European countries. Billion by 2025. and Europe.

Clinical Trials 40

Clinical Trials Science Disease Trials 40

Conversations in Drug Development Trends

APRIL 3, 2024

Leveraging Real-World Data : Utilizing electronic health records and disease registries can help identify potential candidates more efficiently. Complying with Unique Radiopharmaceutical Regulations The regulatory landscape for radiopharmaceuticals is intricate, reflecting the drugs’ complexity.

Trials 81

Trials Clinical Trials Compliance Treatment 81

Drug Discovery World

MAY 17, 2024

Deepika Khedekar , Associate Centralized Clinical Trial Lead at IQVIA Inc, looks at the challenges of utilising artificial intelligence (AI) in oncology clinical research. Consequently, this strategy substantially reduces the failure rate of cancer clinical trials. International Clinical Trials Registry Platform (ICTRP).

Trials 147

Trials Clinical Trials Treatment Research 147

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

DECEMBER 27, 2020

Orelabrutinib is a BTK inhibitor developed by InnoCare for the treatment of cancer and autoimmune diseases. Professor and Director of the Department of Internal Medicine and Lymphoma, Peking University Cancer Hospital. “We China represents a large pharmaceutical market. 1 Source: [link].

Hospitals 52

Hospitals Science Treatment Clinical Trials 52

The Pharma Data

DECEMBER 15, 2020

Dr. Lu Xianping, Chairman of CHIPCREEN BIOSCIENCES, said: “Diabetes is one of the chronic diseases with highest incidence in the world. However, significant clinical needs should be recognized due to the unsatisfied outcome using conventional treatments. China has the largest number of diabetic patients in the world.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Clinical Trials Production 40

The Pharma Data

JANUARY 7, 2021

Prener has led companies and teams across several therapeutic areas, including a focus on rare diseases. a gene therapy company focused on eye diseases. Before that, Dr. Prener was Global Therapeutic Area Head of Hematology and Vice President, Clinical Research Hematology at Baxalta.

Small Molecule 52

Small Molecule Clinical Development Production Science 52

The Pharma Data

DECEMBER 14, 2020

Our highly experienced clinical team will be placing 2-Bromo-LSD into multi-center United States clinical research locations without restriction.”. Dost Mustaq , BDA International Investor Relations Contact Email: ir@blifepharma.com Phone: 646-679-4321.

Bioethics 40

Bioethics Clinical Research Regulations Compliance 40

Agency IQ

NOVEMBER 3, 2023

One non-profit organization, the International Society Association for Probiotics and Prebiotics (ISAPP) , which is dedicated to promoting research in this area, has published consensus statements that have helped to define some of these terms and their associated substances. The regulation of dietary supplements in the U.S.

Therapies 40

Therapies Science FDA Production 40

The Pharma Data

DECEMBER 15, 2020

The Data Contribution Agreement between Diamyd Medical and C-Path will allow for this unique set of fully anonymized clinical trial data to be integrated into an ever-growing list of committed trial data sets within the TOMI-T1D project. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.

Drug Development 40

Drug Development Clinical Trials Vaccine Trials 40

The Pharma Data

DECEMBER 17, 2020

Most recently, Cadavid served as senior vice president and Head of Clinical Development at Fulcrum Therapeutics where he led the development of multiple small molecules for the treatment of genetically defined rare diseases. Immune Regulation – U.K.-based based Immune Regulation Ltd. He spent 27 years at Merck & Co.

Small Molecule 52

Small Molecule Engineering Pharmaceuticals Clinical Development 52

The Pharma Data

DECEMBER 13, 2020

AMPK is a master regulator of several important metabolic pathways, including lipid metabolism, glucose control and inflammation, and is a novel target for NASH and additional chronic and rare metabolic diseases. Harrison, MD, Director, Summit Clinical Research. Summary of New PXL770 Phase 2a Study Results. About NASH.

Trials 52

Trials Disease Treatment Pharmacokinetics 52

Vial

JUNE 12, 2024

Utilizing PROs enables the active participation of patients in their care outcomes – both in a clinical setting and in clinical research. PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. For HF, Savarese et al.

Clinical Trials 52

Clinical Trials Trials FDA Clinical Research 52

PPD

AUGUST 5, 2024

Pulmonary arterial hypertension (PAH) is a progressive and fatal lung disease that is caused or influenced by multiple factors. The clinical sites working on these trials are highly experienced and have a deep understanding of the complexities of successfully running PAH clinical trials. None offers a cure for PAH.

Clinical Trials 98

Clinical Trials Trials Clinical Research Disease 98

Vial

MAY 15, 2024

Vial | Pros and Cons The unprecedented consequences of the COVID-19 pandemic gave rise to the advent of decentralized clinical trials (DCTs), which are studies that use telemedicine and remote or local healthcare professionals to enable participants to join from different locations. billion and now functions as a subsidiary.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Drug Discovery World

AUGUST 24, 2023

However, the substance has shown promise in the field of medicine for a range of diseases and conditions, making its legality a debating point within the drug discovery industry internationally. Of course, while the regulation remains a continuous battle, this does not hinder the research being undertaken.

Clinical Trials 130

Clinical Trials Treatment Regulations Trials 130

Drug Target Review

SEPTEMBER 26, 2023

Human derived induced pluripotent stem cells (hiPSCs) have revolutionised research and are increasingly used for toxicology screening and disease modelling. 27,28 Since the advent of hiPSC technology almost two decades ago enormous progress has been made in many areas of research. Ther Innov Regul Sci. 2018;53(4):519–25.

Drugs 111

Drugs FDA Disease Animal Testing 111

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. Policy-wise, this is still a work in progress.

FDA 40

FDA Research Clinical Trials Regulations 40

Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

FDA 40

FDA Production Regulations Vaccine 40

The Pharma Data

NOVEMBER 10, 2020

According to data published on the WHO website, more than 46 million people have been tested positive for COVID-19, with over 1 million patients in more than 200 counties died from the disease as of November 2 nd , 2020. SHANGHAI , Nov. Effectiveness of molecular hydrogen in treating COVID-19 symptoms.

Hospitals 52

Hospitals Clinical Trials Treatment Therapies 52

Alta Sciences

JULY 31, 2024

For many drug developers, this guidance has been long-awaited, as it emphasizes inclusivity of underrepresented and minority populations not only in late-stage clinical trials but throughout the entire clinical process, including early stages. Discover how drug developers, researchers, and regulators are ensuring this happens.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

The Pharma Data

JANUARY 13, 2021

Clinical data from studies of ensifentrine in the treatment of other respiratory diseases have shown ensifentrine improved lung function, reduced inflammation in the lungs* and reduced symptoms of cough and sputum production. Ensifentrine has been well tolerated in clinical trials involving more than 1,300 people. .

Hospitals 52

Hospitals Clinical Trials Therapies Treatment 52

The Pharma Data

MARCH 15, 2021

Clinical research is a key component of developing. A critical component of our medicinal product development is clinical research. This involves conducting clinical trials in humans to evaluate the safety and efficacy of new pharmaceutical products. new medicines.

Clinical Trials 40

Clinical Trials Trials Compliance Clinical Development 40

Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Combination products are defined by the FDA as : “A product comprised of two or more regulated components (i.e.,

Science 40

Science FDA Production Trials 40

The Pharma Data

DECEMBER 29, 2020

Radboudumc, with nearly 9,000 employees and 3,000 students, is devoted to patient care, education and training, as well as performing excellent basic and clinical research. en/research. TU/e is a research-driven university of international standing, where excellent research and education go hand in hand.

Therapies 52

Therapies Virus Engineering International 52

The Pharma Data

OCTOBER 14, 2020

15, 2020 (GLOBE NEWSWIRE) — Sequana Medical NV ( Euronext Brussels: SEQUA ) , an innovator in the management of fluid overload in liver disease, malignant ascites and heart failure, today announces the appointments of Dr. Michael Felker and Dr. James Udelson as new Heart Failure Scientific Advisors. GHENT, Belgium, Oct.

Clinical Trials 40

Clinical Trials Clinical Research Therapies Marketing 40

The Pharma Data

DECEMBER 23, 2020

With the integration of both parties’ technologies, BioMedion will provide a new operating system for regulated applications operating effectively on one platform in controlled environments. MODAG – Germany’s MODAG initiated a first-in-patient Phase Ib study for anle138b in patients with mild to moderate Parkinson´s Disease (PD).

Licensing 52

Licensing Licensing Vaccine Compliance 52

The Pharma Data

MAY 13, 2021

Non-alcoholic fatty liver disease and fructose: bad for us, better for mice. Grading scale of visceral adipose tissue thickness and their relation to the nonalcoholic fatty liver disease. Exposure to non-nutritive sweeteners during pregnancy and lactation: Impact in programming of metabolic diseases in the progeny later in life.

Disease 52

Disease Production Testimonials Science 52

Agency IQ

AUGUST 9, 2024

has adopted some measures to spur Member States to harmonize their approach towards regulating the possession and research use of narcotics, the specifics nonetheless vary from jurisdiction to jurisdiction. Although the E.U. Notably, in addition to five academic presentations , the workshop featured presentations from the U.S.

Clinical Trials 40

Clinical Trials Regulations Trials FDA 40

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science 40

Science Regulations International FDA 40

The Pharma Data

NOVEMBER 22, 2020

Per the agreement between the foundation and Merck, the foundation, in its role as a funder, intends to provide grant funding to the International Clinical Research Center (ICRC) at the University of Washington Department of Global Health, which is collaborating with Merck on the IMPOWER 22 study. Kenilworth, N.J.,

Trials 52

Trials Clinical Trials International Production 52