ASPET

SEPTEMBER 28, 2023

Benzodiazepine pharmacoresistance is thought in part to result from internalization of synaptic GABA A receptors, which are the main target of the drug. The naturally occurring neurosteroid allopregnanolone is a therapy of interest against SE for its ability to modulate all isoforms of GABA A receptors.

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Therapies Treatment International Drugs 100

Drug Discovery Today

NOVEMBER 10, 2022

A team of surgeons and scientists from the UK, Sweden and Canada, funded by Rinri Therapeutics, has confirmed secure surgical access to the central core of the human cochlea The research, published in Scientific Reports, is critical to the first in-human trials of new cell, gene and drug therapies for the inner ear, and will assist with treatment for (..)

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International Research Therapies Trials 100

Drug Target Review

APRIL 7, 2025

As our understanding of the underlying biology of disease grows more sophisticated, emerging therapies operate on increasingly complex biopathological systems and mechanisms. Safety biomarkers account for adverse effects of a therapy under study. There are several types of biomarkers to consider.

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PPD

DECEMBER 16, 2024

Rising costs have become a persistent challenge for drug developers, driven by a combination of internal and external pressures that have intensified in recent years. Lacking internal expertise or capacity often slows progress, making outsourcing a strategic necessity.

Drug Development 52

Drug Development Clinical Trials Compliance Trials 52

Drug Target Review

DECEMBER 11, 2024

By employing advanced analytical techniques like high-resolution mass spectrometry (HRMS) and carefully calibrating systems with optimal internal standards (IS), we effectively mitigate matrix effects and provide reliable preclinical toxicology data. These solutions must contain analytes and internal standards at known concentrations.

International 52

International Laboratories Drugs Pharmacokinetics 52

New Drug Approvals

APRIL 11, 2025

2] [3] Names Fitusiran is the international nonproprietary name. [4] This article incorporates text from this source, which is in the public domain. ^ “Qfitlia approved as the first therapy in the US to treat hemophilia A or B with or without inhibitors” Sanofi (Press release). 26 March 2025. 28 March 2025.

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Clinical Trials FDA FDA Approval Trials 107

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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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.

Treatment 83

Treatment Clinical Trials Therapies International 83

The Pharma Data

JANUARY 19, 2021

Estrogen Therapy Need Not Stop for Gender-Affirming Surgery. 19, 2021 — For transgender and gender nonbinary (TGNB) patients undergoing primary vaginoplasty, perioperative venous thromboembolism (VTE) occurs rarely, regardless of whether hormone therapy is suspended prior to surgery, according to a study published online Jan.

Therapies 52

Therapies International Research 52

Elrig

MARCH 25, 2025

GOLD Lab collaborates with leading international consortia, including Genomics England and FANTOM (Functional Annotation of the Mammalian Genome). His team has developed CRISPR-Cas and cancer-driver methods for the discovery of oncogenic lncRNAs that are promising targets for therapeutic oligonucleotides.

RNA 59

RNA Bioinformatics Science Pharmacokinetics 59

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.

International 59

International Science Drugs Engineering 59

Drug Target Review

OCTOBER 30, 2024

Organoids will play increasingly crucial roles not only in research and diagnostics, but also in therapies to restore and enhance the human body. About the author Anirban Datta, Head of Discovery Biology at Verseon International Corporation Anirban Datta PhD is the head of discovery biology at Verseon International Corporation.

Treatment 105

Treatment Disease Clinical Trials Research 105

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.

International 52

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.,

International 52

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

MARCH 9, 2021

. (“Biolojic”), a biotechnology company that computationally designs functional antibodies, today announced a research collaboration and license agreement that will leverage Biolojic’s AI-based multibody platform to discover and develop a potential novel antibody-based therapy for the treatment of diabetes.

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Therapies Research Licensing Licensing 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.

International 52

International Treatment Clinical Trials Trials 52

Drug Target Review

JANUARY 14, 2025

Based in South Africa, she has worked extensively with international biotech companies, specialising in therapeutic development for ageing-related diseases and complex conditions such as glioblastoma and autosomal dominant polycystic kidney disease (ADPKD).

Drugs 69

Drugs Protein Expression Science Research 69

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.,

Clinical Supply 52

Clinical Supply Therapies Clinical Trials Packaging 52

New Drug Approvals

APRIL 2, 2025

The application received Breakthrough Therapy , Fast Track and Priority Review designations by the FDA. 11] The FDA granted the application for suzetrigine priority review , fast track , and breakthrough therapy designations. [2] 2] Names Suzetrigine is the international nonproprietary name. [12] under nitrogen. PMID 39775738.

FDA 62

FDA Therapies Trials Treatment 62

New Drug Approvals

MAY 8, 2025

MORE US10918622 US10695323 US10464905 US10342780 US12109193 Medical uses In the United States, pirtobrutinib is indicated to treat relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. [1] 5] It is taken by mouth. [1] 2] PATENTS Guisot, N.

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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

Drug Patent Watch

DECEMBER 9, 2024

While the compound itself couldn’t be patented, various derivatives and combination therapies have been patented, allowing for continued development and distribution. Artemisinin: Nobel Prize-Winning Malaria Treatment Artemisinin, derived from the sweet wormwood plant, has become a crucial treatment for malaria.

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Drugs Drug Development Pharmaceuticals Production 88

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.

International 98

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.

FDA Approval 52

FDA Approval Therapies FDA Treatment 52

The Pharma Data

MARCH 24, 2021

of women who continued on relugolix combination therapy remained responders (menstrual blood loss < 80 mL) through Week 76 compared with 15.1% of women who continued relugolix combination therapy remained responders through Week 104. of women who discontinued treatment at Week 52 (p < 0.0001). weeks after discontinuation.

Therapies 52

Therapies Treatment Science FDA Approval 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

PPD

OCTOBER 31, 2024

These internal issues are compounded by external pressures like inflation, the development of innovative therapies that require complex protocols and the need to comply with shifting regulatory requirements.

Drug Development 52

Drug Development Clinical Trials Trials Drugs 52

The Pharma Data

JANUARY 17, 2021

The Phase IIa POC studies will be conducted after a Phase Ib dose escalation study evaluating the tolerability and activity of proenzyme therapy in patients with advanced solid tumors is completed, planned for 2021, at the Peter Mac Cancer Center, Melbourne, Australia. For more information, please visit www.propanc.com.

Therapies 52

Therapies Clinical Trials Trials Hospitals 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 […]

International 65

International Therapies Research Drugs 65

New Drug Approvals

APRIL 25, 2025

3] Primary endocrine resistance was defined as relapse while on the first two years of adjuvant endocrine therapy (ET) and secondary endocrine resistance was defined as relapse while on adjuvant ET after at least two years or relapse within twelve months of completing adjuvant ET. [3] New Drug Therapy Approvals 2024 (PDF).

FDA 57

FDA FDA Approval Therapies Trials 57

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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