PPD

NOVEMBER 30, 2023

These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. To get a pulse on the changing industry, the PPD clinical research business of Thermo Fisher Scientific surveyed 150 biotech and biopharma leaders for the second year in a row to illuminate industry trends, challenges and sentiments.

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Drug Discovery World

AUGUST 18, 2023

Thermo Fisher Scientific has completed its acquisition of CorEvitas, a provider of real-world evidence for approved medical treatments and therapies, for $912.5 of adjusted earnings per share in 2024. CorEvitas will become part of Thermo Fisher’s Laboratory Products and Biopharma Services segment.

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Alta Sciences

APRIL 16, 2024

Inside The Altascientist: The Benefits of PCR for Your Gene Therapy Programs pmjackson Tue, 04/16/2024 - 19:04 The gene therapy landscape continues to accelerate in preclinical and clinical research, with programs constantly in development for targeted, personalized medicines. WHAT IS THE ALTASCIENTIST ?

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PPD

MARCH 28, 2024

The biotech industry has long been at the forefront of innovation, revolutionizing health care and delivering breakthrough therapies to patients around the world. Through the first few months of 2024, the economic landscape is showing signs of returning to a semblance of normalcy, mirroring the pre-COVID era.

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Trials Clinical Trials Drug Development Clinical Research 52

Conversations in Drug Development Trends

JUNE 21, 2024

The 2024 ASCO Annual Meeting from the American Society of Clinical Oncology is a fantastic platform for clinical researchers to discuss the latest advancements and challenges in oncology research. Currently, there are 12 approved ADC drugs, and several hundred more are in the development pipeline.

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Clinical Trials Clinical Research Immune Response Therapies 64

Drug Discovery World

MARCH 15, 2024

Biotechnology company Allyx Therapeutics has reported positive Phase Ib clinical data for its lead compound, ALX-001, a first-in-class, synapse-targeted, disease-modifying oral therapy in development for neurodegenerative diseases. The findings were presented at the AD/PD 2024 Conference in Lisbon.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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PPD

MARCH 26, 2024

The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceutical companies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.

Pharmaceutical Companies 98

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Drug Discovery World

DECEMBER 26, 2023

Otsuka Pharmaceutical and Ionis Pharmaceuticals Otsuka Pharmaceutical and RNA therapy company Ionis have entered into a licence agreement for Otsuka to acquire exclusive marketing rights to Ionis’ hereditary angioedema (HAE) drug candidate donidalorsen in Europe. His research focuses on immunotherapies for patients with breast cancer.

Small Molecule 130

Small Molecule Drugs Molecular Biology Bioinformatics 130

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.

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Vial

FEBRUARY 8, 2024

To advance new therapies, pharmaceutical, biotech, and medical device companies engage contract research organizations (CROs) for their know-how in navigating the complex landscape of drug development and regulatory pathways and to run clinical trials. How do CROs solve the challenges of managing clinical trials?

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Clinical Trials Trials Clinical Research Research 52

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.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 12, 2024

BY RACHEL COE, MSC | FEB 7, 2024 10:21 PM CST The Bespoke Gene Therapy Consortium A collaborative effort, the Bespoke Gene Therapy Consortium (BGTC) was launched in October 2021 to “accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease.”

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FDA Therapies Clinical Trials Virus 40

Vial

MARCH 1, 2024

Introduction Contract research organizations (CROs) are essential in pharmaceutical research and development (R&D). from 2024 to reach US$129.8 ’s services include supporting life sciences research, analytical solutions, and diagnostics or developing and manufacturing therapeutic interventions. billion by 2029.

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Clinical Trials Clinical Research Laboratories Trials 52

Alta Sciences

JANUARY 23, 2024

Altasciences Appoints New General Manager, Clinical Operations pmjackson Tue, 01/23/2024 - 19:52 Laval, Québec, Monday, January 29, 2024 — Altasciences announced the appointment of James Brazeal as General Manager, Clinical Operations, at its clinical facility in Kansas City.

Clinical Pharmacology 40

Clinical Pharmacology Clinical Trials Pharmaceuticals Clinical Research 40

Drug Discovery World

JANUARY 26, 2024

In the first case of its kind, gene therapy has restored hearing in a patient in the United States. AK-OTOF is a gene therapy being developed for the treatment of sensorineural hearing loss due to mutations in the otoferlin gene (OTOF). “These initial results show that it may restore hearing better than many thought possible.”

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PPD

JANUARY 5, 2023

In an industry survey led by PPD, Thermo Fisher Scientific’s clinical research business, rare diseases emerged as a top therapeutic area in drug developers’ pipelines, with 39% of global biotech and biopharma leaders pursuing therapies in the broad rare disease space.

Disease 52

Disease Trials Clinical Trials Clinical Research 52

Conversations in Drug Development Trends

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.

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Drug Discovery World

APRIL 11, 2024

The Program Committee Chairs commented: “It has been an educational, enlightening, and inspiring week of captivating cancer science and research. As we participate in our closing sessions of the AACR Annual Meeting 2024, let us say what an honour and pleasure it has been to serve as the Program Committee Chairs for this year’s meeting.

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Biochemical Assays DNA Science Pharmacokinetics 130

LifeSciVC

JULY 11, 2023

The meeting brings together tens of thousands of physicians, scientists, patients, advocates, innovators, and those involved in oncology drug development from around the world in order to explore the latest advances in cancer treatment, clinical trials, and translational and clinical research.

Therapies 66

Therapies Trials Clinical Development Science 66

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The road to research on psychedelic products is paved with obstacles.

FDA 40

FDA Trials Regulations Therapies 40

Conversations in Drug Development Trends

NOVEMBER 27, 2023

In recognition of the unmet need and medical urgency for innovative therapies in the sickle cell space, the FDA granted exa-cel Priority Review, with a formal decision expected by December 8, 2023. Why is Casgevy a Breakthrough Gene Therapy for Patients with Sickle Cell Disease? What Does the Future of Gene Editing Hold?

Treatment 75

Treatment FDA Clinical Trials Therapies 75

The Pharma Data

MARCH 23, 2023

Dupixent is the first and only biologic to demonstrate a clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations of COPD (rapid and acute worsening of respiratory symptoms), while also demonstrating significant improvements in lung function, quality of life and COPD respiratory symptoms.

Trials 40

Trials Disease Treatment Therapies 40

Agency IQ

MARCH 1, 2024

In November, Congress passed a short-term CR that extended some federal funding (at current levels) through March 1, 2024. Notably, this explanation of what “excepted staff” does is different in both version of the 2024 contingency plan than what appeared in the 2023 contingency plan. What is happening now?

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The Pharma Data

JUNE 24, 2021

The prognosis for men with advanced prostate cancer has significantly improved since the introduction of novel hormone therapies, but additional therapeutic options are needed for the approximately 25 percent of men with tumors harboring DNA damage response (DDR) gene mutations, who may have poorer outcomes,” said Chris Boshoff, M.D.,

DNA 52

DNA Clinical Trials Trials Biosimilars 52

Drug Discovery World

FEBRUARY 26, 2024

Reece Armstrong speaks to Kathryn Golden , SVP Technical Operations and Manufacturing, bit.bio, about novel technologies, and methods to manufacture human cells for therapies so more patients can access these treatments. Cell therapies have emerged as transformative and potentially curative treatments across a range of disease areas.

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Drug Discovery World

JULY 1, 2024

Together, this research aims to generate evidence for advising and guiding future parents before and during pregnancy. He thinks that the amount of money awarded in total is unique for research in this very specific field and that the research projects complement each other and the international research in this field.

Disease 162

Disease International Research Science 162

Conversations in Drug Development Trends

MAY 30, 2024

These advancements have fostered increased focus from politicians, policymakers, and the investment communities backing academic and industry-sponsored research projects. Researchers established efficacy of edaravone in a 24 week, randomized, placebo-controlled double-blind study in 137 Japanese patients.

Treatment 81

Treatment Small Molecule Clinical Trials Therapies 81

Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. from 2023 to 2030.

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

Codon

JULY 21, 2024

Xander Balwit offers concrete proposals for raising the welfare of animals used in biomedical research for our final article in Issue 03. Of course, AA and P-line rats are not the only research animals bred for the study of disease. We’ll be on a brief hiatus for the next few weeks as we prepare for the next Issue!

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Research Engineering Science Disease 113

PPD

NOVEMBER 8, 2022

PPD, Thermo Fisher Scientific’s clinical research business, surveyed more than 150 biotech and biopharma leaders this year to assess trends in the drug development industry, yielding data we’ll cite throughout this blog. In addition, adaptive trial designs will contribute to innovations in clinical research insights.

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

Drug Discovery World

JUNE 6, 2023

His work has led to crucial insights into the understanding of the mechanisms by which T cells distinguish tumour cells from normal cells and has fueled the advancement of adoptive T-cell therapy approaches in various cancers, including leukemia and pancreatic cancer. From that, we’ll understand better how to use targeted therapies.”

Small Molecule 130

Small Molecule DNA RNA Research 130

Alta Sciences

AUGUST 28, 2023

There are no TBI-specific therapies approved for the treatment of patients suffering brain injury, yet it is estimated that in the U.S. We wish the team at Ischemix continued success on the next Phase of clinical research.” We are proud to support Ischemix in advancing this vital new therapy.”

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Agency IQ

FEBRUARY 2, 2024

BY KIRSTEN MESSMER, PHD, RAC, KARI OAKES | JAN 31, 2024 9:01 PM CST Regulatory Background Cancer is the second leading cause of death in the E.U. Additionally, the plan aims to improve the quality of life for the over 12 million cancer survivors who benefited from earlier detection, effective therapies and supportive care.

Clinical Trials 40

Clinical Trials Trials Treatment Production 40

Agency IQ

OCTOBER 27, 2023

The date on which the FDA would no longer have Congressionally-appropriated funding with which to continue its operations POLITICO / AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 9, 2024

By Sebastian Godoy, MPH | Aug 6, 2024 5:32 PM CDT Background: Psychedelic drug development and regulatory context A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. However, the road to research for these products is paved with obstacles.

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Clinical Trials Regulations Trials FDA 40

Agency IQ

MAY 28, 2024

BY RACHEL COE, MSC | MAY 23, 2024 7:12 PM CDT Yesterday’s Energy & Commerce Health Subcommittee Hearing All three of FDA’s medical product center directors appeared before the Health Subcommittee of the U.S. These are even included with gene therapy, where we had a companion test that came in as an LDT… We reviewed the data.

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