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.

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Drug Discovery World

MARCH 15, 2024

“We are excited to begin the next phase of development with the initiation of two 28-day patient studies, the first studies of ALX-001 in people living with Alzheimer’s and Parkinson’s disease,” commented Tim Siegert, Chief Operating Officer and Co-Founder of Allyx Therapeutics. “We

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Outsourcing Pharma

SEPTEMBER 11, 2023

HumanFirst, a cloud-based software company accelerating patient-centered drug development through AI, has announced the launch of its precision measures platform.

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Worldwide Clinical Trials

JANUARY 24, 2024

Much of what we discuss I covered in my presentation, “Leveraging Genetics to Support Rare Disease Clinical Trials,” at last year’s World Orphan Drug Congress (WODC) EU. In my capstone, I focused on how, if, and when genetic counselors discuss clinical trials with their patients in the context of a counseling session.

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Pharmaceutical Technology

MAY 31, 2023

ATRN-119 is under clinical development by Aprea Therapeutics and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. The drug candidate is administered through oral route.

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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. And will this interaction be safe?

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Drug Discovery World

FEBRUARY 10, 2023

Clinical drug trials have made the headlines this week, as it was revealed that breast cancer still tops the bill for number of clinical studies and the shortcomings in current methods to ensure representation of patient populations in trials were exposed.

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Pharmaceutical Technology

OCTOBER 11, 2022

in milestone payments that include $5m upon receipt of the investigational new drug (IND) from the US Food and Drug Administration (FDA), which is expected late next year. It is claimed to be the only grade of sulforaphane which is suitable for clinical research and will eventually be approved as a medicine.

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XTalks

AUGUST 22, 2023

Yet, 41 percent of people in the US have no knowledge of the clinical research process, and 91 percent say they’ve never been given the opportunity to participate in a trial, according to SCORR Marketing. The availability of new medicines is reliant upon individuals’ willingness to contribute to clinical trials.

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Drug Discovery World

MARCH 28, 2023

Read more about the research on DDW. Catherine Pickering, Chief Executive Officer of iOnctura, said: “The Innovation Passport is an exciting step in the clinical development programme for roginolisib, a drug with a game-changing clinical safety and activity profile.

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XTalks

JANUARY 17, 2024

Oncology is recognized as having the largest drug pipeline of any therapeutic area. Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. It’s very positive and it’s going to help move forward the pathway for new drugs.”

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VirTrial

FEBRUARY 28, 2024

If you missed Signant’s February 2024 webinar about optimizing patient-reported outcomes measurement strategy throughout oncology drug development, we’ve summarized the key takeaways and provided a link for you to watch the recording. Watch the recording You can watch the recorded webinar here.

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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Genital Warts (Condylomata Acuminata). According to GlobalData, Phase I drugs for Genital Warts (Condylomata Acuminata) have a 91% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

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Pharmaceutical Technology

FEBRUARY 24, 2023

(Lopinavir + ritonavir) is under clinical development by Douglas Pharmaceuticals and currently in Phase I for Cervical Intraepithelial Neoplasia (CIN). According to GlobalData, Phase I drugs for Cervical Intraepithelial Neoplasia (CIN) have a 92% phase transition success rate (PTSR) indication benchmark for progressing into Phase II.

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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?

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XTalks

JANUARY 23, 2024

Rare diseases, often overlooked in the broader medical research field, affect a small percentage of the population yet carry a significant burden for those diagnosed and their families. Among these, rare pediatric diseases present unique challenges and opportunities for rare disease drug development.

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ACRP blog

MAY 9, 2024

Their willingness to involve themselves in a new process, and to trust clinical researchers and product developers with their time and wellbeing, is a significant contribution. There are barriers that often derive from trial complexity, deeply rooted historical mistrust, or a lack of awareness about clinical research.

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Drug Discovery World

OCTOBER 16, 2023

The United Kingdom has established itself as a hub for drug discovery expertise worldwide. Here, DDW’s Megan Thomas highlights the research taking place and where this is happening. One of the research themes at the university is Discovery of Medicines, which hosts the Cancer Research UK Newcastle Drug Discovery Unit.

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The Pharma Data

SEPTEMBER 29, 2021

The new FIND-CKD study extends our clinical research for finerenone to a non-diabetic population where the unmet need is high for brand spanking new treatments to delay disease progression.”. In July, finerenone was approved under the name Kerendia® by the us (U.S.)

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XTalks

MAY 19, 2023

It is clear that the clinical research landscape continues to expand at a substantial rate. percent of all trials), underscoring the importance of both interventional and observational research in understanding health and disease​. Rising Cost of Drug Development Developing a new drug is an expensive venture.

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Drug Discovery World

FEBRUARY 12, 2024

DDW’s Megan Thomas spoke to experts from the drug discovery industry about their predictions on what 2024 holds for our sector. Cameron Ross, SVP, Generative AI, Elsevier “AI has the potential to dramatically shorten one of the most costly areas of early drug development – small molecule discovery.

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XTalks

APRIL 11, 2024

The Cumulus Neuroassessment Platform is designed to collect EEG data via a US Food and Drug Administration (FDA) 510(k) cleared and UK Conformity Assessment (UKCA)-marked dry sensor EEG headset. EEG Biomarkers in Clinical Development Historically, technical constraints have hindered the widespread adoption of EEG in research settings.

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Drug Discovery World

DECEMBER 7, 2022

If clinical research into collagen maintains this momentum, we can expect to see innovations in wound healing and bone care making their way to patients in the coming years.”. However, the industry has been slow to invest in collagen-related clinical research. In 2021, the global collagen market was valued at $9.75

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Drug Discovery World

AUGUST 22, 2022

“With the speed to start Phase I studies, quality of clinical sites and a favorable Australian R&D tax credit, Australia is an optimal market for early phase clinical research,” said Alliance CCO Vito Saccente. The post Alliance Pharma expands into Australia appeared first on Drug Discovery World (DDW).

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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.

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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.

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pharmaphorum

DECEMBER 23, 2022

There’s been huge progress in treatments for blood cancer in recent years – but drawbacks of expensive CAR-T cell and injected antibody therapies have led drug developers to look at novel oral therapies as patient-friendly alternatives. Results suggest durable epigenetic re-wiring and provide rationale for intermittent clinical dosing.

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Worldwide Clinical Trials

MAY 1, 2024

For clinical research professionals, this journey often involves reconciling differing feedback from regulatory agencies, each with unique standards, priorities, and expectations. Food and Drug Administration (FDA) Parallel Scientific Advice procedure, which aims to increase dialogue between the two agencies and sponsor companies.

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pharmaphorum

DECEMBER 1, 2022

A recent survey of clinical trial professionals found that more than two-thirds of respondents (61%) believe giving patients choice will have a positive impact on clinical research, and well over half (58%) said that their organisations plan to give patients the option to choose how they participate in clinical trials moving forward.

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pharmaphorum

JUNE 27, 2022

The analysis – from a dataset that spans more than half a million patients – reveals once again the lack of inclusivity in clinical research, which undermines the ability of clinical trials to generate results that reflect the real-world situation in US cancer treatment.

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XTalks

MAY 9, 2024

As we explore Genmab’s strategic vision, technological advancements and the next frontier in antibody research, we gain insights into the future of medicine — a future where Genmab’s cutting-edge therapies are poised to transform patient care and meet the complex challenges of the next generation of healthcare.

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Drug Discovery World

APRIL 25, 2023

“We have reached an important milestone with the dosing of the second participant in our clinical trial evaluating a potentially groundbreaking CAR-T cell therapy to cure HIV,” said Mehrdad Abedi, Professor of Internal Medicine, Hematology and Oncology and co-investigator of the study. “So

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Drug Discovery World

FEBRUARY 10, 2023

Three of the top five most-studied disease areas fell within oncology, with prostate cancer the third most-studied disease, solid tumours fourth, and stroke fifth. “Oncology remains an area of high investment in clinical development, however, 2022 has seen a widespread scale back of overall activity. Download the full report.

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XTalks

JANUARY 17, 2024

Lupus, a complex autoimmune disease, has brought a substantial challenge to researchers and healthcare professionals. Understanding this condition and its various manifestations, as well as developing effective treatments, has been the focus of ongoing investigation in lupus clinical research for many years.

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Roots Analysis

FEBRUARY 10, 2023

Till date, several clinical trials have demonstrated the efficacy and therapeutic superiority ( over conventional treatment options ) of TIL-based therapies. Both industry and non-industry players have demonstrated keen interest in the development of novel TIL-based cell therapies.

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The Pharma Data

JANUARY 24, 2021

Sairiyo is a biotechnology company focused on repurposing and developing improved formulations of naturally derived compounds for serious, rare, and life-threatening diseases with the aim to obtain European Medicines Evaluation Agency and U.S. Food and Drug Administration (“FDA”) approval.

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Drug Discovery World

FEBRUARY 10, 2023

The research will support the clinical development of CTx001, CTx’s lead gene therapy asset for the treatment of GA, by enabling the identification of patients with complement-driven AMD for future interventional studies.

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