Drug Target Review

FEBRUARY 10, 2025

In the rapidly advancing field of cell therapies, Dr Jason Bock has emerged as a leader, known for his innovative approach to optimising the development process. With over 25 years of experience in therapeutics, Bock has played a pivotal role in shaping the future of cell therapies, particularly through his work at CTMC.

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Therapies Treatment Engineering Clinical Trials 64

DrugBank

JUNE 13, 2024

Unlike traditional oral medications with limited bioavailability and potential for erratic absorption, IDDS function as internal drug repositories, delivering precise doses of medication directly at the site of action or into the systemic circulation via precisely adjusted release mechanisms. 

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Therapies Drugs DNA Treatment 74

SCIENMAG: Medicine & Health

JUNE 21, 2023

New research published in the Journal of Internal Medicine demonstrates that optogenetics—which uses light-sensitive proteins to control the activity of targeted cells—is a promising shock-free approach to treating atrial fibrillation (AF), or an irregular, often rapid heart rate, for immediate restoration of regular rhythm.

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Therapies International Treatment Research 64

ASPET

AUGUST 2, 2024

Based on previous studies, we hypothesized that vascular senescence increases the risk of bleeding during warfarin therapy. After validating the models, we examined changes in the International Normalized Ratio (INR) at fixed warfarin doses (0.20 This study aimed to explore these effects using animal models and clinical cohorts.

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Drug Target Review

SEPTEMBER 6, 2024

What trends are driving the increased use of in vivo delivery methods in gene therapy? Generally, the amount of lentiviral vector that is used for in vivo gene therapy is larger than for ex vivo use. How are new therapeutic areas emerging as potential targets for in vivo gene therapy?

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Therapies Vaccine Marketing Disease 59

ASPET

NOVEMBER 17, 2023

This response may result from gamma-aminobutyric acid A receptors (GABA A R) internalization that follows prolonged SE; this receptor trafficking results in fewer GABA A R in the synapse to restore inhibition. Benzodiazepine pharmacoresistance develops when treatment of status epilepticus (SE) is delayed.

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Treatment Therapies International Drugs 100

SCIENMAG: Medicine & Health

JUNE 15, 2023

A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options. Credit: Vanderbilt University Medical Center A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options.

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Treatment Clinical Trials Therapies International 83

Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. The accelerating gene therapy market is expected to grow globally by 16.6% As more therapies are moving out of the lab and into human clinical trials, this paradigm is changing.

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Drug Target Review

FEBRUARY 13, 2024

In light of the International Day of Women and Girls in Science, which celebrates the achievements of women in STEM, could you share an example of a project or research that has been particularly impactful within your field? I started my career in the early stages of the targeted approach to drug therapies.

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International Science Drugs Engineering 59

FDA Law Blog: Drug Discovery

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022.

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Therapies FDA Production Regulations 59

The Pharma Data

JULY 15, 2021

Amgen Inflammation Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients. It’s a commitment that extends beyond introducing novel therapies. Source link:

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International Disease Treatment Science 52

The Pharma Data

JULY 23, 2021

(Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021.

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International Disease Clinical Trials Trials 52

The Pharma Data

AUGUST 30, 2021

.–(BUSINESS WIRE)– Showcasing Teva’s Commitment to Helping Patients Have More Migraine-Free Days, 18 Abstracts will be presented, Including One Late-Breaker, on AJOVY ® (fremanezumab-vfrm) Injection at the International Headache Society and European Headache Federation Joint Congress 2021. Teva Pharmaceuticals USA, Inc.,

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International Clinical Trials Treatment Trials 52

The Pharma Data

MAY 6, 2021

INDIANAPOLIS , May 6, 2021 /PRNewswire/ — With a goal of integrating data and technology to help streamline diabetes management, Eli Lilly and Company (NYSE: LLY) signed strategic international agreements with four companies – DexCom, Inc., 1 International Diabetes Federation. Glooko Inc. IDF Diabetes Atlas, 9 th edn.

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International Therapies Disease Production 52

The Pharma Data

SEPTEMBER 9, 2021

This data will be presented as a late-breaker ePoster during the International Headache Society (IHS) and European Headache Federation (EHF) Joint Congress taking place virtually on Sept. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy. 8-12, 2021. Please click here for full U.S.

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International Treatment Clinical Trials Trials 52

Drug Target Review

OCTOBER 26, 2023

Genome engineering and gene therapies that manipulate DNA sequences in cells have driven a biotechnological revolution over the past decade. Endgame: glybera finally recommended for approval as the first gene therapy drug in the European union. Molecular Therapy 20 , 1831-1832 (2012). Nature 578 , 229-236 (2020).

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Engineering Virus Therapies Immune Response 105

KIF1A

JULY 8, 2023

Notably, last month the FDA granted accelerated approval to a gene therapy for Duchenne Muscular Dystrophy (DMD), a genetic muscle-wasting disorder that primarily impacts boys. Assessments of clinical benefits are still underway, reflecting the FDA’s commitment to accelerated approval of gene therapies for rare disorders.

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Therapies Regulations FDA Treatment 98

The Pharma Data

MAY 26, 2023

State-of-the-art cryogenic freezers alongside material transfer equipment have been installed that are designed to retain the integrity of investigational advanced therapy products by minimizing their time-out-of-environment. With sites in the U.S.,

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Drug Target Review

NOVEMBER 6, 2023

2 It is this complexity that necessitates powerful, targeted combination therapies. 4, 5 More recently, new combination regimens have emerged that incorporate targeted therapies to treat a variety of blood cancers, including multiple myeloma (MM), chronic lymphocytic leukaemia (CLL) and acute myelogenous leukaemia (AML).

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Small Molecule Therapies Treatment Disease 111

Vial

DECEMBER 11, 2023

In the decades since its identification in 1989, advances in clinical research for new Hepatitis C therapies and the introduction of direct-acting antiviral agents (DAAs) have led to viral eradication in more than 98% of patients, resulting in HCV crossing from manageable to being the first curable , chronic viral infection.

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Clinical Research Therapies Research Vaccine 52

PPD

MARCH 13, 2024

Within cell therapy clinical trials, apheresis collections contribute to the specific constituents of the given therapy. Whether this is via an allogeneic (healthy donors) or autologous (patient) approach, the material collected is then manufactured and returned to patients for infusion therapy.

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Clinical Development Clinical Trials Therapies Trials 98

Drug Target Review

AUGUST 17, 2023

This novel mouse model, in addition to a previously generated human FcγRIIB transgenic (Tg) mouse, along with a panel of FcγRIIB mAbs, were used to develop a deeper understanding of FcγRIIB’s inhibitory functions during mAb immunotherapy and how optimal targeting of FcγRIIB would potentiate mAb therapy. 2011 Sep 1;118(9):2530-40. Cancer Cell.

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International Therapies Regulations Clinical Trials 98

The Pharma Data

MAY 27, 2022

Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Kymriah ® (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

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FDA Approval Therapies FDA Treatment 52

SCIENMAG: Medicine & Health

JULY 18, 2023

It’s time to stop prevaricating and explore the use of psilocybin—the active ingredient in ‘magic mushrooms’—and other psychedelics to ease the often overwhelming distress faced by women with late stage gynaecological cancers, urge doctors in a commentary published online in the International Journal of Gynecological Cancer.

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Doctors International Therapies 68

Advarra

NOVEMBER 14, 2024

In an era where clinical trials are increasingly global, it’s more imperative than ever to leverage international expertise. Enhanced objectivity: A DMC composed of diverse international experts can mitigate potential biases arising from local or regional perspectives. local standards of care).

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Clinical Trials Trials International Clinical Research 97

The Pharma Data

SEPTEMBER 11, 2021

– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly. About EMPEROR-Preserved.

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Therapies FDA Hospitals FDA Approval 52

SCIENMAG: Medicine & Health

JUNE 28, 2023

An international team of researchers has developed a new method to deliver drugs into the inner ear. When combined to deliver a gene therapy that repairs inner ear hair cells, the researchers […]

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International Therapies Research Drugs 65

Drug Target Review

DECEMBER 28, 2023

In most cancers, the tumour evolves by acquiring mutations that confer growth advantages or resistance to therapies. However, if the therapy targets only the subclonal (branch) mutations, this will result in the mere ‘pruning’ of specific branches rather than elimination of the whole cancer.

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Bioinformatics Immune Response DNA Vaccine 105

Drug Target Review

JUNE 29, 2023

I think the cell-therapy field has evolved a lot – and is continuing to do so – in the time I’ve been working with this. Regarding the NY-ESO programme that we worked on, I started work on that in 2002 before we even knew that we were going to do cell therapy. I mean, I think cell-therapy is an great place to be.

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Therapies Science Production Cell Biology 115

Alta Sciences

JUNE 12, 2024

Along with managing non-GLP nonhuman primate (NHP) studies at our Sacramento, CA, site, Ashley coordinates study logistics with sponsors and internal departments, monitors study conduct, and maintains steady communication with sponsors. Additionally, I get to analyze study data and learn more about the specific therapy that we evaluated.

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Doctors International Research Science 98

Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

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Therapies RNA DNA Engineering 52

Codon

JULY 27, 2023

But what happens if you restore these cone cells, using gene therapy? approved a gene therapy for hemophilia A for the first time. It’s called Roctavian and it’s only available for people who don’t have antibodies against AAV5, which is the viral vector used to deliver the gene therapy. From Moazami et al.

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Therapies RNA DNA Engineering 52

The Pharma Data

JUNE 7, 2023

Bayer strengthens gene therapy portfolio with lipid nanoparticle technology from Acuitas Therapeutics Bayer AG is joining forces with Acuitas Therapeutics, Inc., ” “We are delighted to partner with Bayer in the area of gene therapy. . ” “We are delighted to partner with Bayer in the area of gene therapy.

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Therapies RNA Licensing Licensing 40

Conversations in Drug Development Trends

APRIL 4, 2024

To help integrate these various regulatory standards, the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use was founded in 2016. The ICH M10 guidelines aim to streamline this process, reducing redundancy in drug development and facilitating faster access to new therapies.

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Small Molecule Clinical Trials Pharmaceuticals Pharmaceutical Companies 80

The Pharma Data

APRIL 22, 2023

While no cure is available for MS, existing disease-modifying therapies in the form of small molecule and protein drugs either directly target the self-reactive immune cells or broadly dampen inflammation. “Current MS therapies do not specifically target myeloid cells. who is a Core Faculty member at the Wyss Institute.

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Therapies Immune Response Small Molecule Engineering 40

SugarCone Biotech

OCTOBER 6, 2024

The trick is bind to these “internalizer proteins” with a bispecific antibody or fusion protein so they drag a second bound targeted protein with them. This works because everything that is bound up with the internalizing protein complex gets degraded. But what’s also weird is the apparent specificity.

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Targeted Protein Degradation International Engineering Therapies 69

Drug Target Review

OCTOBER 1, 2024

Indeed, I’m afraid to say I experienced some biases regarding my lack of experience when I joined my first company, especially from non-medical colleagues who saw me as an internal competitor. That paper, of which I was in the authorship, remains a current point of reference for that therapy usage.

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