DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. This high attrition rate directly results from the scientific and regulatory hurdles that drug candidates must overcome. The market for cardiovascular drugs, valued at 155.6

Pharmaceuticals 77

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Advarra

AUGUST 10, 2023

The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases. Operation Warp Speed for Rare Diseases looks to accelerate both drug development and approval. The post Operation Warp Speed for Rare Diseases: Expected Boom in Drug Development and Approval appeared first on Advarra.

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Drug Development Disease Therapies Engineering 52

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.

Clinical Research 98

Clinical Research Pharmaceutical Companies Clinical Development Drug Development 98

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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Clinical Trials Clinical Development Trials Pharmaceutical Companies 136

H1 Blog

JULY 30, 2024

Increasing diversity in clinical trials not only makes the findings more relevant to various patient groups, but also enhances knowledge about the disease or medical product being studied. Hence, pharmaceutical companies need to start making preparations to ensure compliance with the new requirements.

FDA 59

FDA Clinical Trials Compliance Pharma Companies 59

Conversations in Drug Development Trends

APRIL 4, 2024

The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies. Understanding and implementing the ICH M10 guidelines is not just a regulatory requirement; it’s a step towards more efficient and effective pharmaceutical research.

Small Molecule 80

Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

The Pharma Data

MAY 5, 2022

Validated Measurable Residual Disease Assays are Critical for the Rapid Development of Future Novel Therapeutics for Patients with Acute Myeloid Leukemia. 1 Clinical trials for new therapies in AML are becoming increasingly lengthy to complete based on the traditional clinical endpoint of survival.

Disease 52

Disease Clinical Trials Drug Development Pharmaceutical Companies 52

DrugBank

MARCH 7, 2024

The Quest for Ozempic-Like Alternatives Ozempic, a GLP-1 receptor agonist developed by Novo Nordisk, has demonstrated remarkable efficacy in promoting weight loss and improving metabolic health. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.

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Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 81

H1 Blog

SEPTEMBER 14, 2023

As pharmaceutical companies turn to CROs (Clinical Research Organizations) for trial design and technology, there are new opportunities emerging with healthcare data intelligence that can help ensure a bright future for the industry and to make trials more effective, efficient and accessible. million data points.”

Clinical Trials 59

Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 59

Advarra

APRIL 4, 2024

One crucial aspect of this process involves establishing data safety monitoring boards (DSMBs) (also known as data monitoring committees [DMCs]) to oversee clinical trials. Traditionally, pharmaceutical sponsors have formed a new DSMB for each individual trial.

Clinical Trials 52

Clinical Trials Pharmaceutical Companies Trials FDA 52

PPD

JUNE 20, 2024

Acceleration in every step of clinical research is critical to pharmaceutical developers. Despite advances in technology and innovation, pharmaceutical leaders say that trials are increasingly complex, particularly when it comes to patient recruitment and site engagement. With a median delay of 12.2

Clinical Research 52

Clinical Research Research Clinical Trials Pharmaceuticals 52

DrugBank

NOVEMBER 4, 2024

While the demand for novel antibiotics is undeniable, the industry still struggles with the harsh realities of antibiotic drug development. This costly, high-risk development pipeline has high attrition rates and uncertain market returns.  

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Pharmaceutical Companies Government Pharmaceuticals DNA 71

The Pharma Data

JANUARY 12, 2021

a leader in precision medicine and artificial intelligence (AI)-enabled patient-centric oncology clinical trial enrollment, announced today it has launched its SYNERGY-AI Oncology Clinical Trial Command Center (OCTCC) with the mission to disrupt and accelerate the clinical trial enrollment process.

Clinical Trials 52

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Conversations in Drug Development Trends

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 Advantages of Midsize CROs In contrast to large CROs, midsize CROs like Worldwide Clinical Trials offer a unique value proposition to the market.

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Clinical Trials Clinical Development Clinical Research Pharmaceutical Companies 52

DrugBank

OCTOBER 4, 2024

Emerging Markets Emerging markets, particularly in Asia and Latin America, have become increasingly attractive destinations for pharmaceutical M&A activity. The growing middle class and government initiatives to improve access to medicines have created an ecosystem for pharmaceutical companies seeking growth opportunities.

Pharmaceuticals 81

Pharmaceuticals Pharmaceutical Companies Therapies Marketing 81

Vial

FEBRUARY 15, 2024

Clinical trials play a crucial role in advancing medical breakthroughs, but effective management is essential to unlock their full potential. Pharmaceutical companies often face challenges in conducting clinical trials due to the need for substantial knowledge, time, and resources. over the forecast period (2022-2030).

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Pharma Companies Clinical Trials Compliance Trials 52

Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. Vial’s track record includes over 750 completed trials and a network of more than 35 research sites.

Clinical Trials 52

Clinical Trials Trials Clinical Research Compliance 52

Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. Our approach is informed by our combined 30+ years in rare disease clinical development and our time in various stakeholder roles, such as scientists, CRAs, and project managers.

Disease 81

Disease Clinical Trials Trials Pharmaceutical Companies 81

Drug Target Review

SEPTEMBER 19, 2023

puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938.

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Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

Perficient: Drug Development

SEPTEMBER 10, 2024

Powering Patient-Centric Clinical Trials with AI and Data Explore how Life Sciences Cloud leverages AI to power comprehensive, customized, next-generation clinical trials for pharmaceutical companies. Gain insights into AI-driven solutions for optimizing clinical trials and enhancing customer experiences.

Science 52

Science Clinical Trials Pharmaceutical Companies Trials 52

DrugBank

APRIL 12, 2024

Over the past decade, the drug discovery landscape has been revolutionized by the adoption of artificial intelligence (AI) and machine learning (ML), witnessing early adopters leapfrog into pioneering technologies aimed at streamlining the drug development process and curtailing associated costs.

Drugs 83

Drugs Clinical Trials Pharmaceutical Companies Pharmaceuticals 83

The Pharma Data

JULY 8, 2021

The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinical trials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

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Predictive Oncology

FEBRUARY 7, 2023

“We’re providing that richness of tumor diversity and the population diversity that normally the companies will not be able to see until they are in a clinical trial and [the drug is] challenged against a multitude of different patients.”

Clinical Trials 52

Clinical Trials Pharmaceutical Companies Trials Pharmaceuticals 52

DrugBank

JUNE 27, 2024

  The benefits of drug repurposing are clear: development times and costs are significantly reduced due to existing knowledge about the drug's properties. These include matching molecular signatures, virtual screening, and analyzing large datasets from health records and clinical trials.

Drugs 72

Drugs Pharma Companies Clinical Trials Computational Chemistry 72

Drug Target Review

FEBRUARY 1, 2024

But commitment to neuroscience drug development is critically important given the significant unmet medical needs and the ways in which patients, caregivers, and families suffer. This can present challenges when attempting to recruit an enriched patient population for clinical trials.

Therapies 104

Therapies Drug Development Disease Clinical Development 104

Conversations in Drug Development Trends

MAY 14, 2024

As the strategists for Worldwide Clinical Trials’ rare disease sponsors, we design customized solutions that make a difference in achieving successful outcomes. Our approach is informed by our combined 30+ years in rare disease clinical development and our time in various stakeholder roles, such as scientists, CRAs, and project managers.

Disease 52

Disease Clinical Trials Trials Pharmaceutical Companies 52

Advarra

AUGUST 16, 2022

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.

Disease 52

Disease Clinical Trials FDA Approval FDA 52

Drug Target Review

JANUARY 8, 2024

We are at the forefront of drug development in an area of research called cellular rejuvenation, which is an approach that has the potential to address many diseases of ageing by restoring aged and injured cells to a more youthful and resilient state. a commercial stage pharmaceutical company.

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Science Disease FDA Approval Clinical Trials 145

Advarra

DECEMBER 14, 2023

Sponsor study team members and research sites each play a critical role in clinical trial executions. Both inspection findings and inspection failures could reduce the quality of the trial data, with inspection failures being most disruptive. In addition, many research trials are conducted over the course of many years.

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Compliance FDA Clinical Trials Trials 52

H1 Blog

JUNE 8, 2023

In this blog post, we’ll explore how early diversity in HCP engagement can drive better outcomes and equity in drug development. The drug development process is known to be often expensive, lengthy, and full of trial and error before finding success.

Drug Development 52

Drug Development Science Pharmaceutical Companies Production 52

Vial

APRIL 18, 2024

Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding. Specifically, the global ophthalmic clinical trials market, valued at USD 1.5 from 2023 to 2030.

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

The Pharma Data

JANUARY 17, 2021

18 , 2021 /PRNewswire/ — Hanmi Pharmaceutical Co., plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment, Triple-acting new drug for NASH (non-alcoholic steatohepatitis) treatment as well as various other innovations in metabolic disease, oncology and rare disease fields.

FDA Approval 52

FDA Approval FDA Pharmaceuticals Clinical Trials 52

Codon

NOVEMBER 3, 2024

As an undergraduate biology student, I spent some time in a TB lab working on antibiotic resistance — a growing concern for drug developers. A 1994 review of 14 prospective trials and 12 case-control studies revealed that the BCG vaccine reduced the risk of TB by 50 percent. Subscribe to Asimov Press.

Vaccine 83

Vaccine Trials Therapies Treatment 83

The Pharma Data

DECEMBER 28, 2020

Nasdaq: MBRX) (Moleculin or the Company), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Annamycin for treatment of soft tissue sarcomas. .

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FDA Clinical Trials Drugs Pharmaceutical Companies 52

Altus Drug Development

MAY 31, 2022

From natural health products to life-saving medicines, all pharmaceutical products must undergo an analytical method development process. Through analytical method development, validation, and transfer, drug development and manufacturing are kept safe, efficient, and compliant with the law.

Pharmaceuticals 52

Pharmaceuticals Production Clinical Trials Drug Development 52

Codon

SEPTEMBER 29, 2024

The average pass rate of phase I trials went up by 5 percent. It wasn’t a silver bullet to the hard problem of drug development, but it wasn’t too far off either. Unlike what many predicted, the rise of computation as a dominant force in drug development did not kill “Big Pharma.”

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Drug Target Review

JUNE 19, 2024

Also, many companies never reached the point where they received validation from big pharmaceutical companies. That would provide wonderful information as we think about then going into a first-in-human clinical trial. Mr Culley served on the Board of Orphagen Pharmaceuticals, Inc.

Therapies 84

Therapies Small Molecule Pharmaceutical Companies Molecular Biology 84