STAT News

OCTOBER 13, 2022

Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinical trial, a significant setback for the company’s only medicine in clinical development. Continue to STAT+ to read the full story…

Clinical Trials 105

Clinical Trials Clinical Trials Trials Drugs 105

Drug Discovery World

MARCH 15, 2024

Using Exploristics’ study simulation software platform, KerusCloud, the companies established a more efficient, data-driven approach to study design and protocol development within Exonate’s clinical development programmes in retinal vascular diseases.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

Pharmaceutical Technology

APRIL 26, 2023

Biotechnology company Adcentrx Therapeutics has raised $38m in Series A+ financing to advance its pipeline of new antibody-drug conjugate (ADC) therapeutics into clinical development. ADRX-070 is the company’s lead candidate and is anticipated to enter a first-in-human Phase I clinical trial in the second half of 2023.

Clinical Development 147

Clinical Development Development Clinical Trials Clinical Trials 147

Worldwide Clinical Trials

DECEMBER 7, 2023

Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.

Clinical Development 333

Clinical Development Clinical Trials Clinical Trials Trials 333

Drug Discovery World

MAY 17, 2023

In the In Conversation With series, a part of the free DDW podcast, DDW speaks with members of the drug discovery industry about their work and how it helps turn science into business. In this latest episode, DDW’s Megan Thomas is in conversation with Dr Michael Pace, Global & Strategic Feasibility Expert at Rho.

Clinical Trials 52

Clinical Trials Clinical Trials Medicine Trials 52

Outsourcing Pharma

OCTOBER 20, 2023

Feedback has been submitted to the US Food and Drug Administration (FDA) with guidelines intended for sponsors of clinical trials related to psychedelic compounds.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Drugs 105

Clinical Trial Podcast

SEPTEMBER 26, 2022

When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development. Cohen to the Clinical Trial Podcast.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Clinical Research 98

Drug Discovery World

JULY 17, 2023

Analysis of 13,490 clinical trials finds almost a third have been cancelled during Phase II amidst an overall decline in clinical development productivity. Data analytics company Phesi has released the results of its mid-year global analysis of all clinical trials conducted in 2023 to date.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

Drug Discovery World

JANUARY 17, 2023

In the In Conversation With series, a part of the free DDW podcast, DDW speaks with members of the drug discovery industry about their work and how it helps turn science into business. . In this latest episode, DDW’s Megan Thomas is in conversation with two experts when it comes to clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

Drug Discovery World

JANUARY 17, 2023

The newest addition to the free DDW podcast is the In Conversation With series, where DDW speaks with members of the drug discovery industry about their work and how it helps turn science into business. . In this latest episode, DDW’s Megan Thomas is in conversation with two experts when it comes to clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

Drug Discovery World

SEPTEMBER 4, 2023

A new whitepaper has introduced the concept of ‘cross-over’ options in cancer clinical trials, as a way to make trials more patient-centric in design. It also encourages sponsors, investigators and regulators to advance patient-centric trial designs.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Development 52

Advarra

AUGUST 14, 2023

The clinical research industry is only becoming more complex and competitive as organizations are inundated with multiple trials and tight deadlines. The clinical trial process is both expensive and time-consuming, and ends more often in failure than success. of respondents reported they know what clinical trials are.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Worldwide Clinical Trials

MARCH 7, 2024

When conducting first-in-human (FIH) clinical trials, small to midsize pharmaceutical and biotechnology companies are faced with several crucial choices that can shape the trajectory of their drug development pathway. The post Navigating the Global Clinical Landscape: CTA or IND for Your First-in-Human Study?

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Outsourcing Pharma

MARCH 5, 2024

Clerkenwell Health, a company that delivers clinical trials for the treatment of complex mental health volunteers for trials into the use of psychoactive medications for treating PTSD, is in search of 40 ex-military volunteers.

Trials 111

Trials Clinical Trials Clinical Trials Drugs 111

Drug Discovery World

SEPTEMBER 6, 2023

million female patients, meaning 45% of data were collected from women. The new service harnesses data from Phesi, and uses Krystelis’ writing services to empower sponsors to improve diversity from the trial planning stage onwards. In a further 2023 analysis on a subset of data from 22.4 million patients, Phesi discovered only 10.2

Clinical Development 64

Clinical Development Development Clinical Trials Clinical Trials 64

Worldwide Clinical Trials

APRIL 15, 2024

As the clinical research landscape continually evolves, the choice of a Contract Research Organization (CRO) partner can significantly impact the success of drug development programs. The post Reimagining CRO Partnerships: The Emerging Preference for Midsize Organizations appeared first on Worldwide Clinical Trials.

Clinical Trials 130

Clinical Trials Clinical Trials Clinical Development Clinical Research 130

Outsourcing Pharma

MARCH 18, 2024

On Friday (March 15) leading pharma Auxilius Pharma announced promising results from the first-in-human clinical trial of its originative product-in-development, AUX-001.

Development 93

Development Trials Clinical Trials Clinical Trials 93

XTalks

JANUARY 17, 2024

To gain insights into how clinical trials for lupus can be enhanced with RWD sources, we spoke with Frederico Calado, VP of Global Real-World Solutions at Alira Health , and Dr. Kaleb Michaud, Professor, Division of Rheumatology, University of Nebraska Medical Center.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

XTalks

OCTOBER 12, 2022

Magnetic resonance imaging (MRI) has had a part in clinical trials for more than three decades now. However, the role of MRI in new drug clinical trials can involve diagnosis of lesions and determination of their severity, early identification of therapeutic responders to drug treatment and treatment monitoring and follow-up.

Clinical Trials 93

Clinical Trials Clinical Trials Trials Drugs 93

Drug Discovery World

JANUARY 30, 2023

Dominic Elliston , Managing Director of Evoke Galliard and Evoke Incisive Health, shares his take on how effective clinical trial communications is the key to expediting the delivery of new and extraordinary treatments. What’s that got to do with clinical trials? Tell us about yourself, Dominic.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Development 52

Worldwide Clinical Trials

FEBRUARY 21, 2024

During clinical development, new chemical entities (NCEs) require an absorption, metabolism, and excretion (AME) study. At Worldwide, our early phase team has conducted these studies for over 20 years, gaining invaluable experience and insights into best practices for an AME study.

Clinical Trials 180

Clinical Trials Clinical Trials Pharmacy Trials 180

XTalks

MAY 20, 2021

Today is Clinical Trials Day 2021 — a day for recognizing the importance of clinical research in protecting and improving global health. Amid the alarmist headlines posted by other media outlets, Xtalks has remained balanced in its reporting of COVID-19 clinical trial results and safety data.

Clinical Trials 105

Clinical Trials Clinical Trials Trials Vaccination 105

XTalks

MAY 11, 2023

Clinical trials are essential for the development of new treatments for rare diseases, but they can be complex and challenging to execute. That mission is really important to me because I think it’s the only way we’re going to accelerate drug development in rare disease.

Clinical Trials 97

Clinical Trials Clinical Trials Trials Development 97

XTalks

NOVEMBER 14, 2023

Novo Nordisk shared new clinical trial data that shows its obesity drug Wegovy (semaglutide) can also reduce the risk of various heart complications, including heart attack, in certain individuals. In trial data shared by Novo in August, Wegovy (2.4 The SELECT trial began in 2018 and is Novo’s largest trial to date.

Trials 104

Trials Drugs Clinical Trials Clinical Trials 104

Outsourcing Pharma

OCTOBER 17, 2022

The company, through its subsidiary, PPD, announced that it had created a network that would provide learning materials to those investigators and research sites looking to use decentralized clinical trials (DCTs) for drug development.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Development 52

XTalks

MAY 6, 2022

In this interview, Xtalks spoke with experts from eClinical Solutions , Katrina Rice, Chief Delivery Officer, Data Services; and Diane Lacroix, Vice President, Clinical Data Management, about clinical data management for modern day digital clinical trials. In addition, 43.4 percent were using or piloting omics data.

Clinical Trials 98

Clinical Trials Clinical Trials Trials Life Science 98

Drug Discovery World

DECEMBER 7, 2022

Data analytics company Phesi analysed 2,358 clinical trials involving collagen. In the first 10 months of 2022, there were more than 225 new trials, compared with 125 in 2012. Phesi’s analysis shows that just 27% of trials received industry funding. In 2021, the global collagen market was valued at $9.75 billion by 2028.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Clinical Research 52

Drug Discovery World

OCTOBER 18, 2022

A working group has been created to measure and compare the carbon footprint of centralised (traditional site-based) and decentralised clinical trials. The Clinical Trials Environmental Impact Community of Interest (CoI) was started by Pistoia Alliance member, Syneos Health. Growing pressure on life sciences.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Life Science 52

pharmaphorum

FEBRUARY 11, 2021

Pharma companies face many challenges when involving patients in the design of clinical trials – but doing so can have huge benefits further down the line, improving the sustainability and quality of research. Involving patients in discussions.

Clinical Trials 101

Clinical Trials Clinical Trials Trials Clinical Research 101

Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SinoMab BioScience intends to commence a Phase I clinical trial in China to evaluate SM17’s safety profile.

Immune Response 273

Immune Response Clinical Trials Clinical Trials Antibody 273

Worldwide Clinical Trials

OCTOBER 17, 2022

BioPharma Dive sat down with our Gary Fishbein for a conversation on how to de-risk trials without sacrificing cost or speed. These measures, applied across the continuum of a compound’s development, can improve the likelihood of successful late phase trials. Optimizing enrollment.

Trials 100

Trials Clinical Trials Clinical Trials Drugs 100

Drug Discovery World

SEPTEMBER 12, 2022

Business and profitability remain unquestionably important in the drug discovery community. We are hopefully nearing the tail-end of a pandemic that made the whole world become participants in that deep learning experience of what clinical development is. Never before was the whole world a potential patient.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

BioPharma Reporter

DECEMBER 13, 2021

Memo Therapeutics AG will receive CHF 10.5m (US $11.4m) from the Swiss government to clinically develop a SARS-CoV-2 antibody against COVID-19, allowing it to start Phase 1 studies in Q1, 2022.

Antibody 143

Antibody Clinical Trials Clinical Trials Clinical Development 143

Drug Discovery World

NOVEMBER 30, 2023

Biotechnology company Certa Therapeutics has revealed positive Phase II clinical trial data for FT011 in patients with scleroderma. The US Food and Drug Administration (FDA) recently granted Orphan Drug Designation for FT011 for the treatment of systemic sclerosis (scleroderma).

Drug Trials 59

Drug Trials Trials Drugs Clinical Trials 59

Pharmaceutical Technology

MAY 2, 2023

Plus Therapeutics has expanded its partnership with Piramal Pharma Solutions (PPS) to produce additional cGMP liposome intermediate drug products. This will help to meet the rising demand for Plus Therapeutics’ lead investigational targeted radiotherapeutic, rhenium (186Re) obisbemeda, for clinical trials that are underway and planned.

Production 130

Production Drugs Clinical Trials Clinical Trials 130

Pharmaceutical Technology

FEBRUARY 14, 2023

Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.”

Antibody 130

Antibody Drugs Clinical Development Licensing 130

Pfizer

FEBRUARY 16, 2023

These study participants, representing approximately half of the total recruited participants in the trial, are being discontinued following violations of Good Clinical Practice (GCP) at certain clinical trial sites run by a third-party clinical trial site operator.

Clinical Trials 76

Clinical Trials Clinical Trials Vaccination Vaccine 76