Drug Discovery World

FEBRUARY 10, 2023

First-line AZ treatment for adults with biliary tract cancer approved The MHRA has approved Imfinzi in combination with gemcitabine and cisplatin as a first-line treatment for biliary tract cancer. The research will support the clinical development of CTx001, CTx’s lead gene therapy asset for the treatment of GA.

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Cytel

JANUARY 23, 2023

This has aligned with the broader curation of a number of new dose-escalation and efficacy designs for clinical development in oncology. A nuanced understanding of these considerations enables sponsors to ask more complex questions like:

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The Pharma Data

SEPTEMBER 29, 2021

to enhance outcomes, new treatments which will target kidney-specific disease mechanisms are highly desired,” said Hiddo L. Christian Rommel, Member of the chief Committee of Bayer AG’s Pharmaceutical Division and Head of Research and Development.

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Drug Discovery World

FEBRUARY 12, 2024

In 2024, we can expect another wave of innovative new drugs to be developed using the technology, given that the AI-fuelled small molecule discovery pipeline is growing by almost 40% annually.” Looking even further into the future, Industry 4.0

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The Pharma Data

AUGUST 31, 2021

In addition, as part of the label update, this indication has been revised to be for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. Source link: [link].

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Drug Discovery World

MARCH 5, 2024

In her day-to-day role, she is responsible for the development of UCB’s epilepsy discovery strategy, working with researchers to advance understanding of epilepsies while ensuring candidates for a future clinical treatment pipeline to improve the lives of those living with the condition.

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Conversations in Drug Development Trends

JANUARY 24, 2024

Many parents are hesitant to pursue testing since it will not affect the patient’s care management, as several of these diseases have no approved treatments, such as Fragile X, a syndromic form of autism. Throughout my research, I discovered that genetic counselors are more likely to discuss clinical trials with rare disease patients.

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Drug Discovery World

MARCH 28, 2023

iOnctura, a clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer, has been awarded the innovative medicine designation, the Innovation Passport, for roginolisib, for the treatment of metastatic uveal melanoma by the Medicines & Healthcare products Regulatory Agency (MHRA).

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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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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Drug Target Review

MAY 7, 2024

These algorithms can swiftly navigate extensive databases of clinical trial information to pinpoint potential matches between patients and trials, considering various factors such as treatment protocols and geographical considerations.

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Precision for Medicine

DECEMBER 1, 2023

December 1, 2023 — Precision for Medicine, the first global biomarker-driven clinical research organization, is the recipient of a new accreditation from The College of American Pathologists (CAP) for its tissue and histopathology laboratory in Winston-Salem, North Carolina. Winston-Salem, Nc.,

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Precision for Medicine

APRIL 7, 2023

These labs are an integral part of the transformational infrastructure of capabilities Precision has built to accelerate the development of complex therapies.” This convergence of trials, labs, and data sciences is driving faster clinical development and approval. Canada, Europe, and Australia.

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Conversations in Drug Development Trends

JULY 29, 2024

Despite these advancements, challenges for widespread effective care remain due to the heterogeneous patient population, opening the door for further development of treatments for T2D. Obesity is a major factor in the prevalence of T2D, and it is vital to develop T2D treatments with this in mind.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. billion each year.

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Precision for Medicine

JUNE 26, 2023

This acquisition allows us to vastly expand our capabilities and deliver efficient and strategic solutions that drive the path forward for manufacturing complex treatments while ensuring reliable and consistent drug supply chains.” This convergence is driving faster clinical development and approval. Bethesda, Md.,

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Precision for Medicine

MAY 24, 2023

CRO Leadership Awards recognize companies judged by customers as exceeding expectations BETHESDA, MD, May 25, 2023 – Precision for Medicine, the first biomarker-driven clinical research organization (CRO), announces its wide recognition in the 2023 CRO Leadership Awards. For more information, visit PrecisionForMedicine.com.

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The Pharma Data

JANUARY 6, 2021

7, 2021 /PRNewswire/ — UNION therapeutics A/S ( UNION ) today announces that the US Food and Drug Administration (FDA) has approved an Investigational New Drug program (IND) for oral orismilast; a next generation PDE4-inhibitor for the treatment of plaque psoriasis in adults. One step closer to a novel treatment.

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The Pharma Data

SEPTEMBER 28, 2021

Triple-negative carcinoma grows and spreads faster than other sorts of carcinoma and consequently features a worse prognosis,” said Dr. Vicki Goodman, vice chairman , clinical research, Merck Research Laboratories. Importantly, this treatment regimen are often utilized in combination with different chemotherapy agents.

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Vial

FEBRUARY 29, 2024

However, despite their increasingly ubiquitous role in the clinical research industry, the question remains as to the extent of their participation. That is, how many clinical trials are actually managed by these organizations? Understanding the Numbers: How Many Clinical Trials Utilize CROs? between 2023 and 2032.

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Drug Discovery World

DECEMBER 22, 2022

Examples of these changes include refining sample size, abandoning treatments or doses, or stopping the trial early if success or lack of efficacy is clear. Shelley McLendon has more than 25 years of clinical research experience, 19 of which are tenured at ICON. About the author .

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Vial

APRIL 24, 2024

Oncology Despite significant progress in cancer research, many patients face limited treatment options. The Vial Oncology CRO offers sponsors solutions to support their research, including optimized study design, innovative patient recruitment strategies, and advanced data analytics.

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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.

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LifeSciVC

JULY 11, 2023

Redig, SVP and Head of Clinical Development at HotSpot Therapeutics, as part of the From The Trenches feature of LifeSciVC The American Cancer Society for Oncology (ASCO) annual meeting is among the highlights of the clinical oncology calendar. By Amanda J. In his presidential address, outgoing ASCO president Dr.

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Creative Biolabs

MAY 25, 2022

For decades, cytotoxic-based chemotherapy has been the main treatment for all kinds of cancers. Fu, 2022) Clinical research progress of ADC After decades of efforts, more than 100 ADCs are currently under clinical development.

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The Pharma Data

JANUARY 14, 2021

We are strongly encouraged by these data and the potential for a frontline targeted treatment that can improve overall survival,” said Zev A. Associate Professor of Medicine at UCLA, Co-director of the Gastrointestinal Oncology Program and Director of Early Phase Clinical Research at the Jonsson Comprehensive Cancer Center.

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PPD

NOVEMBER 21, 2023

To keep a pulse on this rapidly changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 leaders in the biopharma and biotech industries for the second consecutive year. Differences in size, resources and agility have led the two groups to take different approaches to clinical development.

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Drug Target Review

JUNE 6, 2023

In this IO arena, we continue to search for additional treatments that can further benefit patients. Immune checkpoint inhibitors, a well-established class of IO treatments, are designed to improve the ability of T-cells to fight cancer by removing inhibitory or suppressive mechanisms that may dampen the anti-cancer functions of T cells.

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The Pharma Data

SEPTEMBER 11, 2020

In an effort to slow the spread of the disease and prevent a second wave, pharma companies around the world are continuously looking to advance new methods of treatment. This week’s round up dives into developments from companies based in Australia and the US. Saama Technologies, Inc. ,

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The Pharma Data

APRIL 8, 2021

Based on an interim analysis conducted by an independent Data Monitoring Committee, KEYTRUDA monotherapy demonstrated a statistically significant and clinically meaningfully improvement in DFS compared with placebo. Europe and Japan in combination with axitinib for the first-line treatment of patients with advanced RCC.

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The Pharma Data

JUNE 25, 2021

We hope to build on this important research and provide new treatment options to kidney cancer patients.”. “As The late-breaking results will be presented in the Plenary session of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #LBA5) on Sunday, June 6, 2021. of patients in the placebo arm.

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The Pharma Data

NOVEMBER 9, 2020

The trial looked at a combination of Keytruda from Merck and Lenvima from Eisai for the treatment of advanced renal cell carcinoma (RCC). The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. Merck , also known as MSD outside of the U.S.

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Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Typical clinical development timelines for anticancer drugs average an estimated 6.7

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Drug Target Review

FEBRUARY 29, 2024

Nevertheless, the potential to pioneer and move the needle for patients with few treatment options drives me to push through. Advancements in gene and cell-based medicine have the potential to meaningfully address diseases where there are no available treatments. The impact on patients and their families could be life-changing.

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Drug Discovery World

AUGUST 8, 2022

Earlier this year, pharmaceutical company Novo Nordisk announced positive results from Phase I & II clinical trials investigating its antibody treatment for haemophilia A. . We look forward to moving into phase 3 clinical development, which is due to commence in Q4 2022.

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Conversations in Drug Development Trends

MAY 30, 2024

Since marketing authorization for the first breakthrough treatment in 1994, the steady increase in clinical trials reflects the community’s commitment to finding effective ALS treatments despite the numerous hurdles associated with clinical trial design, from proof-of-concept to pivotal trials.

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Advarra

NOVEMBER 29, 2022

The FDA, already chronically understaffed, reassigned many reviewers to focus on COVID treatments. Many companies are unable to develop these niche therapies because of the associated costs and limited financial return. Communication issues between sponsors and the FDA is an ongoing issue in CGT development.

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