Drug Discovery World

JANUARY 17, 2023

This Phase 2b clinical trial will focus on first-line treatment of HepatoCellular Carcinoma (HCC) patients with Genoscience Pharma’s drug candidate ezurpimtrostat (GNS561). . The first patient received the initial treatment on 2 January 2023 and Genoscience Pharma is providing ezurpimtrostat and operational support. .

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. They mark a significant shift in clinical research, utilising technology to capture real-time patient data. Digital biomarkers could be the cornerstone of this evolution.

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Drug Discovery World

JUNE 30, 2023

Whether it be a monoclonal antibody to treat peanut allergy, or using artificial intelligence (AI) to identify influenza drug targets, each discovery reflects the level of scientific innovation and diversity of approaches being employed in drug development today. The top stories: Could a monoclonal antibody treat peanut allergy?

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Drug Discovery World

MAY 8, 2024

In the clinical trial management and planning systems space, we are already seeing how the practical implementation of these tools is accelerating drug development and bringing innovative medicines to patients faster. There is now growing pressure for regulators to take action.

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Drug Discovery World

AUGUST 18, 2023

Real-world evidence is a high growth market segment as pharmaceutical and biotechnology customers, as well as regulating bodies, are increasingly looking to monitor and evaluate the safety of approved therapies and examine their effectiveness and value in the post approval setting. “We of adjusted earnings per share in 2024.

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Laboratories Clinical Research Therapies Regulations 130

Vial

MAY 20, 2024

Distinguishing the Roles of Preclinical vs. Clinical CROs in Clinical Research Randomized clinical trials are the gold-standard of evidence-based medicine, representing the culmination of the long, arduous drug development pipeline. What is a Pre-Clinical CRO? The global preclinical CRO market was estimated to be valued at US$5.7

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Clinical Research Research Clinical Trials Laboratories 52

Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 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.

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Drug Discovery World

AUGUST 22, 2024

Prolonging health span with drug development Life Biosciences aims to restore and prolong a patient’s health span by targeting the underlying biology of ageing and increasing the quality of years one spends in good health compared with just increasing the total number of years one lives.

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Drug Discovery World

MAY 6, 2024

Even before this, however, Amsterdam was established as an important centre for drug development. In a boost to cancer research for both regions, in November 2023, Cancer Research UK and the KWF Dutch Cancer Society (KWF) announced a multi-project strategic partnership.

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Drug Discovery World

NOVEMBER 8, 2023

While traditional approaches to clinical trials have helped us manage some of these conditions to a certain extent, they alone may not provide us the velocity we need to accelerate the research and conquer these diseases, raising the possibility that technologies such as artificial intelligence (AI) may hold the answer.

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Conversations in Drug Development Trends

NOVEMBER 10, 2023

 Instead, the medical community and regulating agencies need to balance all aspects when making decisions, working in partnership with their patients. Collaborating If you’re interested in learning more about pain therapeutics research, check out our pain expertise.

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Clinical Trials Trials Compliance Doctors 75

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. is the largest dedicated food and drug law firm in the country. life sciences industry.

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Drug Discovery World

OCTOBER 18, 2023

Sara Donnelly, Director of Research Planning and Business Development at PhoenixBio USA explores why the right pre-clinical model is essential for teams wanting to advance adeno-associated virus vector-based gene therapies. However, NHP models cannot fully predict AAV transduction in the human liver.

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Perficient: Drug Development

NOVEMBER 22, 2023

So, without further adieu, here are our top insights from HCIC 2023. 1. — These headlines and their supporting stories provide a contextual benchmark, or if we’re being really honest, a research shortcut. Senior Strategist Kayla Brown speaks at HCIC 2023 on Consumer Centricity With an Enterprise Digital Experience Platform 4.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. There is, however, one cannabis-derived drug product that the FDA has approved, which is Epidiolex (cannabidiol).

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Drug Discovery World

AUGUST 1, 2023

Evonetix hopes the platform can change the way DNA is prepared and delivered to users within synthetic biology and helps accelerate research across life sciences. Advancing research This year too saw pharmaceutical company Roche open its Institute of Human Biology (IHB) to help advance research into human model systems such as organoids.

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Drug Target Review

JANUARY 5, 2024

Scientists from the Centre for Genomic Regulation and the Wellcome Sanger Institute have found the allosteric control sites in the KRAS protein, the highly sought after targets for drug development. For the purposes of drug discovery, it’s like turning the lights on and laying bare the many ways we can control a protein.”

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Regulations Pharmaceutical Companies DNA Treatment 98

Conversations in Drug Development Trends

FEBRUARY 22, 2023

Rare Disease Day on February 28th is a chance for rare disease communities to come together as one and join in conversation with stakeholders searching for treatments, raising money to support research, and changing the way healthcare and governments interact with patients. What will have the greatest impact on rare disease patients in 2023?

Disease 52

Disease Clinical Trials Trials Treatment 52

The Premier Consulting Blog

NOVEMBER 12, 2023

This feedback prompted the FDA to release a second paper in 2021 titled “ Artificial Intelligence/Machine Learning (AI.ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which outlined the agency’s five-pillar approach to regulating AI/ML. AI will be able to identify trends in manufacturing-related deviations. (

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Drug Discovery World

FEBRUARY 7, 2023

So, how could software like this impact drug discovery , an industry that has so far embraced the possibilities of artificial intelligence (AI)? Many journal publishers argue that a chatbot can’t be listed as an author and are being forced to create policies about how it can be used, or not, in the research setting.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 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.

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PPD

OCTOBER 18, 2023

Continued expansion of the biotech industry is occurring in parallel, with an estimated compound annual growth rate of 13.96% from 2023-2030. 1 With this growth comes increased demands for laboratory services at all steps across the development process.

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Drug Target Review

JULY 4, 2023

1 Regulators invest significant consideration balancing quality-of-life measures with overall survival when assessing novel oncology treatments. Antibody drug conjugated with cytotoxic payload. antibody linked to a biologically active cytotoxic (anticancer) payload or drug 3d rendering. 2022 [cited 2023 Feb 10];30(2):71.

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Agency IQ

AUGUST 23, 2024

Transitions, the LDT rule and cybersecurity Courtney Lias has been Acting Director of CDRH’s in vitro diagnostics office, known as OHT7, since the departure of Tim Stenzel at the end of 2023. At the end of 2023, former OHT7 Director TIMOTHY STENZEL retired from the agency. OHT2 is cardiovascular devices).

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FDA Laboratories Regulations Clinical Trials 40

Drug Discovery World

JULY 11, 2023

While the potential for better insights has grown, acquiring powerful tools that can harness that data, and turn it into useful, actionable information, has increasingly become one of the most important aspects of life science research. Biomarker discovery is becoming a vibrant area for exploiting the power of AI and ML.

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Science Drugs FDA Engineering 100

Drug Target Review

AUGUST 9, 2024

The science behind drug formulation The formulation of a drug is both an art and a science, requiring a deep understanding of the drug’s chemical and physical properties. 1 Challenges in drug formulation Developing a successful drug formulation is fraught with challenges.

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Science Drugs Compliance Drug Development 59

Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Regulatory Excellence - Licenses for Schedule I through IV drug substances.

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Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Drug Discovery World

JANUARY 30, 2024

Lentivirus strategies are one of the most widely used tools in biomedical research and clinical testing, says Stella Vnook, CEO, Likarda. “Dr Developing financial assistance programs and exploring alternative funding models are important.

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FDA Law Blog: Drug Discovery

MARCH 13, 2023

Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). By Larry J.

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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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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 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.

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FDA Science Regulations Biosimilars 40

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. Read AgencyIQ’s analysis of a lower court’s ruling.

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FDA Science Clinical Trials Regulations 40

DrugBank

MARCH 7, 2024

Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. As larger players scout for innovative solutions, partnerships with smaller firms offer a pathway to accelerate drug development and diversify product portfolios.

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Vial

FEBRUARY 15, 2024

To address these challenges, many companies outsource their clinical trials to contract research organizations (CROs) with established protocols, global reach, and therapeutic area expertise1. According to the 2022 Polaris Market Research Report , the global clinical trials outsourcing market reached USD 38.11

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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. The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2%

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Clinical Trials Trials Compliance Clinical Research 52

Agency IQ

JUNE 26, 2023

Today, the FDA unveiled a contract notice that explains the process for how it will develop that report, obtain public input, and deliver the report’s final recommendations. a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people. regulators. In the U.S., Recently, U.S.

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