pharmaphorum

JANUARY 25, 2022

As the area of bringing a digital therapeutic to market means passing the same level of regulatory scrutiny as a traditional, pharmaceutical therapy, this means “prescription digital therapeutics must undergo extensive clinical trials to demonstrate their safety and effectiveness before they ever reach patients,” said McCann.

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Drug Discovery World

DECEMBER 6, 2023

“We are impressed by the unique delivery and editing technologies that Eligo has developed, and we believe this will set the stage for Eligo to forge new paths in the application of in vivo gene-editing technologies.” The investment will fuel pre-IND and IND activities to achieve early human data readouts in a PhIb/IIa clinical trial.

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Gene Editing Gene In-Vivo Genetics 52

Roots Analysis

FEBRUARY 27, 2024

How is the genome editing market landscape evolving: Currently, there is an evident increase in demand for complex biological therapies (including regenerative medicine products), which has created an urgent need for robust genome editing techniques. The global genome editing market is anticipated to grow at a CAGR of 12.6%

Genome 40

Genome Genomics Gene Gene Editing 40

Drug Discovery World

APRIL 11, 2023

12 The trial Tezepelumab was well tolerated in patients with severe asthma and resulted in clinically meaningful reductions in asthma exacerbations in NAVIAGTOR & SOURCE clinical trials and no clinically meaningful differences in safety results between the tezepelumab and placebo groups. to 0.53; P<0.001).3

Clinical Trials 98

Clinical Trials Clinical Trials In-Vivo Medicine 98

Drug Discovery World

JANUARY 18, 2024

Poolbeg Pharma, a biopharmaceutical company focused on the development and commercialisation of medicines targeting diseases with a high unmet medical need, has announced promising in vivo results for POLB 001 in addressing cancer immunotherapy-induced cytokine release syndrome (CRS). million cases of cancer by 2030 1,2.

In-Vivo 64

In-Vivo Antibody Clinical Trials Clinical Trials 64

Drug Discovery World

APRIL 8, 2024

Jakob Nikolas Kather, Professor of clinical artificial intelligence at Technical University Dresden in Germany, then discussed how AI applications can be used to derive prognostic and predictive information from routine pathology slides.

In-Vivo 52

In-Vivo In-Vitro Antibody Protein 52

Drug Discovery World

SEPTEMBER 26, 2022

AstraZeneca’s Tezspire (tezepelumab) has been approved in the European Union as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product. . Official comments .

Clinical Trials 52

Clinical Trials Clinical Trials In-Vivo Medicine 52

Drug Discovery World

MAY 9, 2023

The recent passage of the FDA Modernization Act, which removed the requirement for animal testing when suitable alternatives are available, has highlighted the inadequacy of animal models most often used for in vivo research. Fewer than 5% of oncology drugs that enter clinical trials in the US receive US FDA approval.

Development 52

Development Drugs In-Vivo Clinical Trials 52

pharmaphorum

JANUARY 29, 2021

Cutting edge’ is, for once, a truly apt description when it comes to gene editing – both because the field is pushing medicine into areas we might never have dreamed possible, and because these technologies involve literally cutting DNA at a specific point in the genome. Zinc fingers. billion in funding.

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Gene Editing Gene Gene Therapy In-Vivo 145

XTalks

APRIL 24, 2023

Melanie Blank, clinical team leader for General Medicine Branch 1 at the US Food and Drug Administration’s (FDA) Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), the agency is seeing one or two new applications coming in every week for new gene therapies for different diseases.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

pharmaphorum

FEBRUARY 13, 2022

Quris’ BioAI safety prediction platform – which is based on human tissue samples on chips, nanosensors and machine learning – will be compared to traditional in vitro and in vivo laboratory techniques for spotting toxicity. The post Merck will assess Quris’ AI ‘patient-on-a-chip’ drug safety appeared first on.

Drugs 98

Drugs In-Vivo In-Vitro Pharma Companies 98

Drug Discovery World

APRIL 5, 2023

A collaborative network The CBC operates as a collaborative network of 19 Institutes with longstanding drug discovery know-how from target identification through to proof-of-concept clinical trials. The post Only non-US company joins cancer drug discovery consortium appeared first on Drug Discovery World (DDW).

Drugs 52

Drugs In-Vivo In-Vitro Engineer 52

pharmaphorum

JULY 22, 2021

We have completed phase 2 trial of a multi-antibody drug for influenza, CT-P27, and since 2015 we have been developing a therapeutic antibody to treat the Middle East Respiratory Syndrome (MERS), CT-P38. In just over a year, Celltrion Healthcare says it has identified and delivered a potential treatment for COVID-19.

Antibody 105

Antibody Clinical Trials Clinical Trials Trials 105

Drug Discovery World

AUGUST 22, 2023

Claire D’Abreau-Hayling, Chief Scientific Officer at Sandoz, examines how generic products can relieve industry pressure and improve access to essential medicines. Off-patent medicines today account for about 80% of global prescriptions at an estimated 20% of the total cost. What are complex generics?

Production 52

Production Bioequivalency In-Vivo In-Vitro 52

The Pharma Data

JANUARY 17, 2021

Joe Dupere, CEO of Ixaka, commented: “Ixaka’s broad offering of integrated cell and gene therapy capabilities, encompassing cell-based products and an innovative in vivo gene delivery platform, provides a strong foundation for our ambitions to become a leader in cell and gene therapies. A total of $15.4 A total of $15.4 References 1.

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Gene Therapy Gene In-Vivo Genetics 40

Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels. In October, the U.S.

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Development Bioequivalency Generic Drugs Production 242

Camargo

APRIL 28, 2021

Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility. First Steps Toward Initiating Pediatric Clinical Studies. Data Collection from Preclinical and Adult Studies.

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Clinical Trials Clinical Trials In-Vivo Drugs 130

Drug Discovery World

AUGUST 14, 2023

Over the past few decades, the incredible progress in personalised medicine has led to the development of life-saving cell and gene therapies (CGT). For instance, in a trial where patients are selected based on a specific human leukocyte antigen (HLA) type, the FDA requires the use of a fully certified, FDA approved Companion Diagnostic.

Gene Therapy 52

Gene Therapy Marketing Gene DNA 52

pharmaphorum

FEBRUARY 19, 2021

US biotech Excision BioTherapeutics has raised $60 million to test a potential HIV cure in the clinic, which would use CRISPR technology to snip out the viral code from human cells and tissues. We have proven the technology and candidate programs in vitro and in vivo in both small animal models and primate models.

Gene Editing 105

Gene Editing In-Vivo DNA In-Vitro 105

Drug Discovery World

JANUARY 23, 2023

Researchers have discovered a clinical drug that sensitises glioblastoma (GBM) cells to radiotherapy and could replace the current standard of care. In addition, they discovered that cladribine, a clinical drug, activates DGKB and inhibits DGAT1. GBM is a WHO grade IV brain tumour with dismal prognosis.

FDA Approval 52

FDA Approval Drugs In-Vivo In-Vitro 52

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

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Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain 246

pharmaphorum

OCTOBER 8, 2020

Scribe has designed, engineered and tested thousands of evolved CRISPR enzymes to build an advanced platform for creating breakthrough in vivo treatments,” said Oakes. At the moment, most CRISPR-based medicines rely on the modification of cells outside the body, that are then used as therapies. Benjamin Oakes.

Gene Editing 69

Gene Editing Gene In-Vivo Clinical Trials 69

Drug Discovery World

JUNE 30, 2023

Research tools, safety testing and regenerative medicines – these endless stem cell applications are powering precision, speed, and new modalities in drug development. Stem cells for use in drug discovery Stem cells are fast becoming an invaluable tool in the drug discovery process. This article is sponsored by Charles River.

Development 52

Development Drugs In-Vitro Gene Therapy 52

XTalks

FEBRUARY 10, 2023

According to a recent review published in Nature , as of April 2022 almost 1,800 active cell therapy clinical trials were listed in ClinicalTrials.gov, a 33 percent increase from 2021. In a recent webinar, Dr. Vassallo discussed the operational considerations for complex cell therapy clinical trials.

Clinical Trials 52

Clinical Trials Clinical Trials Trials Gene Therapy 52

Drug Discovery World

JULY 22, 2022

For example, in randomised clinical trials of patients with non-small cell lung cancer (NSCLC), pembrolizumab has been shown to be effective in slowing down disease progression and improving survival rates 1. demonstrated the ability to model clinical responses to ACT in autologous HIS mice 4. Jespersen et al.

In-Vivo 52

In-Vivo Engineer In-Vitro Antibody 52

The Pharma Data

JUNE 17, 2022

Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). A modified version of the Cv2.1169 antibody was also effective at treating SARS-CoV-2 infection in mice and hamsters.

Antibody 52

Antibody In-Vivo In-Vitro Immune Response 52

The Pharma Data

JANUARY 12, 2021

13, 2021 /PRNewswire/ — IO Biotech , a clinical-stage biopharmaceutical company developing novel, immune-modulating anti-cancer therapies based on its proprietary T-win® technology, announced today that it has raised EUR 127 million in Series B financing. COPENHAGEN, Denmark , Jan. On December 15, 2020 , the U.S.

In-Vivo 52

In-Vivo Antibody Vaccination Vaccine 52

Drug Discovery World

JULY 5, 2023

It’s a brilliantly exciting time where we’re beginning to harvest the fruits of decades’ worth of breakthrough research undertaken by the world’s brightest scientists, and we’re seeing those advances in basic science translated to the clinic, where they’re making a difference in patients’ lives. Mark Garner, PhD.,

Research 98

Research Protein Scientist Immune Response 98

Drug Discovery World

JANUARY 17, 2024

Brett Swansiger, Chief Commercial Officer at ANGLE discusses the importance of liquid biopsies in precision medicine trials for cancer. Furthermore, oncology clinical trials are frequently challenged by low enrolment rates, failure to achieve primary endpoints, study design complexity and limited funding 5.

Medicine 59

Medicine DNA Genome Genomics 59

Drug Discovery World

SEPTEMBER 6, 2022

This area of medicine, which turns our own bodies into agents of combat to fight disease, has quickly become one of the most promising fields in treating deadly diseases such as cancer, central nervous system disorders and even musculoskeletal conditions. . billion, compared to $19.9 million price point per dose. Cancer is king .

Gene Therapy 52

Gene Therapy Gene Manufacturing Medicine 52

Drug Discovery World

SEPTEMBER 28, 2022

AI-based diagnostic software and clinical trials technology proved to be two of the most attractive health investments, alongside mental health and wellness and medical imaging companies. . But has its application been as revolutionary as industry bods predicted? . The simple answer is no. The unavailability of good data .

Pharma Companies 52

Pharma Companies Drugs In-Vivo Genetics 52

Pharmaceutical Technology

APRIL 4, 2023

Formerly known as CTX001, exa-cel is an investigational, autologous, ex vivo CRISPR/Cas9 gene-edited therapy. The BLAs are supported by data obtained from the ongoing Phase III CLIMB-111 and CLIMB-121 trials, along with an ongoing long-term follow-up CLIMB-131 trial. The applications include requests for priority review.

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Gene Therapy Gene Editing In-Vivo Gene 246

Drug Discovery World

NOVEMBER 16, 2022

Therefore, while researchers can understand just how a drug molecule impacts a cell, they can’t be sure that it will perform the same when used in-vivo. . One of these benefits is how cells grown in this type of culture are able to interact with their surroundings, similar to how they would perform in-vivo. 2D vs 3D .

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Drugs In-Vivo In-Vitro Scientist 97

The Pharma Data

OCTOBER 22, 2020

The approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” said Barry Zingman, MD, Professor of Medicine at the Albert Einstein College of Medicine and Montefiore Medical Center, New York.

FDA Approval 52

FDA Approval Trials Clinical Trials Clinical Trials 52

XTalks

DECEMBER 20, 2023

This includes analyzing how drug combinations may impact individual patients or groups of patients before even entering a clinical trial. With a staggering 90 percent of drugs failing in clinical trials, AI has the potential to help improve these statistics.

Life Science 119

Life Science Gene Editing Development Clinical Trials 119

XTalks

AUGUST 17, 2020

Cue Biopharma is a Cambridge, Massachusetts-based clinical-stage biotechnology company that is focused on developing injectable immune biologics using its proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform. Cell-Based Immunotherapy vs. Immune Biologics. cells, receptors) to treat disease.

Protein 98

Protein Engineer Immune Response In-Vivo 98

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) has determined that OAV-101 intrathecal (IT) clinical trials for spinal muscular atrophy (SMA) patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019. SVP, Chief Medical Officer, Novartis Gene Therapies. “We

Clinical Trials 52

Clinical Trials Clinical Trials Gene Therapy Trials 52