FDA Law Blog: Drug Discovery

MAY 19, 2024

By Sarah Wicks — On May 21, 2024, the EveryLife Foundation for Rare Diseases (ELF) will host a Scientific Workshop at the National Press Club in Washington, D.C. aimed at identifying and characterizing the challenges in developing therapies for ultra-rare diseases and conditions that affect exceedingly small populations.

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LifeSciVC

JANUARY 16, 2024

recent announcements from Merck and Sanofi for obesity and broader metabolic disease). Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Join the club. Additional trials (e.g., ALT) continue to build momentum in the indication.

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Drug Discovery World

JANUARY 17, 2023

Genoscience Pharma, a clinical-stage biotech company developing lysosomotropic drug candidates for the treatment of cancer, fibrosis and auto-immune diseases through autophagy modulation has launched the ABE-LIVER study, along with trial sponsor Grenoble University Hospital. . The trial . Context .

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PPD

NOVEMBER 30, 2023

As we approach the end of 2023, it’s time to reflect on the past 12 months and how advances in drug development shaped the pharma and biotech industries. These shifts are a prelude to further change and progress in the clinical trial landscape in 2024. Five Predictions for the Drug Development Industry in 2024 1.

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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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Drug Discovery World

APRIL 29, 2024

Current areas of attention include post-traumatic stress disorder (PTSD), palliative care, agitation in Alzheimer’s disease, spasticity in multiple sclerosis, inflammatory skin conditions, Tourette syndrome, idiopathic hypersomnia, and potential activation in immunotherapy treatments in oncology 2,3. Accessed 3 Jan 2024. Explor Med.

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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.

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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.

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Drug Discovery World

FEBRUARY 9, 2023

The US Food and Drug Administration (FDA) has granted Rare Paediatric Disease (RPD) Designation to SynaptixBio’s drug candidate for TUBB4a leukodystrophy – a genetic and debilitating condition which mainly affects babies and young children. This is a key part of our overall strategy,” he said. “To

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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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Drug Discovery World

FEBRUARY 13, 2024

The attention on this tool brought further waves of interest into how AI could be deployed across the pharmaceutical and drug discovery sectors. However, that’s not to say the future of drug discovery isn’t exciting, or that AI won’t play a part in it, just that the potential of AI within pharma has yet to be reached.

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Drug Discovery World

JANUARY 22, 2024

Masaru Kanekiyo , Chief of Molecular Immunoengineering Section (MIS) of the Vaccine Research Center (VRC) at the US National Institute of Allergy and Infectious Diseases (NIAID), will present ‘Structural vaccinology for influenza’. According to an article in Acta Pharmaceutica Sinica B , 90% of clinical drug development fails” 3.

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Fierce BioTech

MARCH 5, 2024

During this discussion, experts will share methods for identifying promising drug targets and biomarkers by leveraging linked clinico-genomic data in advancing therapeutic development and its application from research to clinical care. On Demand Start Date Wed, 04/24/2024 - 13:30

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Drug Discovery World

MAY 21, 2024

Modern experimental procedures, such as immunisation, B-cell screening, and synthetic library generation, have been pivotal in developing approximately 80 FDA-approved antibody therapeutics. While Antiverse focuses on the antibody discovery process, many artificial intelligence applications exist throughout the drug development process.

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Drug Discovery World

MAY 6, 2024

Even before this, however, Amsterdam was established as an important centre for drug development. The company is now investigating a promising gene therapy for Huntingdon’s disease in a Phase I/II trial, with patients already showing signs of preserved neurological function. The CDD will sponsor and manage KWF-supported trials.

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Drug Discovery World

JANUARY 30, 2024

Dr Naldini open new doors for cures for otherwise untreatable genetic diseases with the full impact of his work still untapped”, she said. Lentivirus strategies are one of the most widely used tools in biomedical research and clinical testing, says Stella Vnook, CEO, Likarda. “Dr

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Drug Discovery World

APRIL 23, 2024

Over the past 20 years research has increasingly linked concussions to neurogenerative conditions, including dementia, Alzheimer’s disease and CTE, a degenerative brain disease. Tremendous strides have been made with other diseases, yet there are still no FDA-approved drug therapies for TBI.

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Drug Discovery World

JANUARY 19, 2024

BPGbio, an AI-powered biopharma that focuses on oncology, neurology, and rare diseases, has announced new data from a Phase IIa clinical trial of its lead candidate, BPM31510, in patients with advanced pancreatic cancers at the annual ASCO Gastrointestinal Cancers Symposium, being held 18-20 January 2024, in San Francisco.

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Drug Discovery World

JANUARY 8, 2024

Importantly, regulatory guidelines facilitate this, allowing us to use highly translatable animal model data to complement leaner clinical trials in support of registration,” said Michael Lobritz, Head of Infectious Diseases, Roche Pharma Research and Early Development (pRED). Government incentives provide one solution.

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Agency IQ

JUNE 26, 2023

FDA quietly kicks off process that could inform future rare disease regulatory reforms Reforms buried within the FY2023 omnibus spending bill require the development of a new report looking at the regulatory processes of the U.S. Meanwhile, in the EU rare diseases are defined using a different set of criteria. In the U.S.,

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Drug Discovery World

MAY 8, 2024

There has been an increasing focus over the past few years about the uses of AI and machine learning in drug discovery and development, particularly in their ability to identify molecules capable of treating disease and to simulate trial results.

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Drug Discovery World

DECEMBER 26, 2023

Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical commented: “Otsuka is committed to the development of drugs for rare diseases such as autosomal dominant polycystic kidney disease (ADPKD).

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Drug Discovery World

JUNE 7, 2023

Panellists will discuss the following questions: Where will the opportunities be in 2024? How important will mRNA-based vaccines be in treating viruses and diseases such as cancer? Is it true that the next era will belong to antibody drug conjugates? What can we expect from the cell & gene therapy market?

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Alta Sciences

APRIL 4, 2024

Thank You for Being You nbartlett Thu, 04/04/2024 - 20:14 HTML Here’s to you… who forge new paths into the unknown and shape the future of medicine for generations to come. Image Video Thumbnail_Thank you_03.jpg jpg Weight 1

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Drug Discovery World

JUNE 27, 2023

Panelists will discuss the following questions: Where will the opportunities be in 2024? How important will mRNA-based vaccines be in treating viruses and diseases such as cancer? Is it true that the next era will belong to antibody drug conjugates? What can we expect from the cell & gene therapy market?

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Drug Discovery World

JUNE 22, 2023

Panelists will discuss the following questions: Where will the opportunities be in 2024? How important will mRNA-based vaccines be in treating viruses and diseases such as cancer? Is it true that the next era will belong to antibody drug conjugates? What can we expect from the cell & gene therapy market?

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Drug Discovery World

JUNE 15, 2023

Panelists will discuss the following questions: Where will the opportunities be in 2024? How important will mRNA-based vaccines be in treating viruses and diseases such as cancer? Is it true that the next era will belong to antibody drug conjugates? What can we expect from the cell & gene therapy market?

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Drug Discovery World

JUNE 8, 2023

Panelists will discuss the following questions: Where will the opportunities be in 2024? How important will mRNA-based vaccines be in treating viruses and diseases such as cancer? Is it true that the next era will belong to antibody drug conjugates? What can we expect from the cell & gene therapy market?

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Drug Discovery World

SEPTEMBER 7, 2022

From research to clinical trials, FDA assessment and monitoring beyond, the process is by no means quick; anything that helps expediate the route for getting a drug to market is desirable. According to MarketsandMarkets the global AI in drug discovery market is projected to reach $1,434 million by 2024 from $259 million in 2019.

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Drug Discovery World

MARCH 12, 2024

RA: What advantages does a plant-based approach bring to drug development? These confounding factors limit the opportunity for big pharma, especially considering the poor access to the complex small molecule pharmacophores known to have a link to the target disease and from which drug discovery programmes can be rolled out.

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Drug Discovery World

JANUARY 21, 2024

Proximity-inducing drugs: Using technological innovation to build the next generation of medicine Simon Bushell, SVP of Molecular Discovery of Entact Bio, has over two decades of scientific and strategic leadership experience in drug discovery. His recent research focuses on vaccines against influenza and other (re)emerging viruses.

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Alta Sciences

JANUARY 11, 2024

It is estimated that there are over 6,000 monogenic diseases, affecting over 350 million people worldwide; for these diseases, cell and gene therapy may provide hope for a cure. However, there are significant challenges associated with the successful development of these complex, leading-edge therapies.

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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Sygnature Discovery

OCTOBER 10, 2023

Microglia are neuro-inflammatory cells that constitute ~10% of the brain’s cell population and are a key therapeutic target in the development of adequate treatments for Alzheimer’s Disease and other neurodegenerative conditions.

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Vial

MAY 20, 2024

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. The two broadest categories of drug development can be separated into the preclinical and clinical research stages. over this period.

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PLOS: DNA Science

APRIL 18, 2024

Clues to combatting a devastating disease can come from identifying people who have gene variants – mutations – that protect them, by slowing the illness or lowering the risk that it develops in the first place. That’s what the researchers wanted to find out, publishing their findings in the January 2024 Cell.

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Drug Discovery World

SEPTEMBER 26, 2023

Cancer is a collection of diseases that are characterised by unchecked cell multiplication. Both acquired and inherited genetic mutations, as well as modifications inside and outside the cell, can contribute to cancer development. In this special section, Nobel Laureate James P.

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