ASPET

SEPTEMBER 22, 2023

These results suggest that brain damage can be long-lasting or permanent if nerve agent-induced SE in infant victims is treated with midazolam at a delayed timepoint after SE onset, while antiglutamatergic treatment with tezampanel and caramiphen provide significant neuroprotection.

Treatment 100

Treatment FDA Drugs 100

Broad Institute

JULY 11, 2024

Targeted drug treatment leads tumor cells to imitate viral infection By Ari Navetta July 11, 2024 Breadcrumb Home Targeted drug treatment leads tumor cells to imitate viral infection Exploiting "viral mimicry," mIDH1 inhibitors trick tumors into thinking they are infected with a virus.

Treatment 72

Treatment Immune Response Virus Drugs 72

SCIENMAG: Medicine & Health

JANUARY 16, 2024

Scaling drugs to a patient’s weight prevents adverse events from overtreatment and treatment failure due to underdosing. Knowing a patient’s weight is necessary for many weight-based medications such as thrombolytics, anticoagulants and numerous cardiovascular medications. Credit: Alex Dolce, Florida Atlantic University […]

Research 89

Research Treatment Drugs 89

KIF1A

JULY 15, 2023

When the brain’s electrical activity changes enough to cause noticeable changes in behavior, we call that event a seizure. By identifying short and subtle changes in movements, we may be able to characterize epileptic events with more precision. From Gschwind et al. 2023, Neuron.

Disease 98

Disease Treatment Research Therapies 98

ASPET

JUNE 30, 2023

Myeloproliferative Neoplasms (MPNs) are hematological malignancies that result from acquired driver mutations in hematopoietic stem cells (HSCs), causing overproduction of blood cells and an increased risk of thrombo-hemorrhagic events. This study aims to determine a personalized treatment strategy.

Therapies 100

Therapies Treatment Drugs 100

Drug Target Review

AUGUST 6, 2024

Autoimmune diseases : Rheumatoid Arthritis : ADCs targeting specific immune cells or inflammatory mediators can provide more precise treatment options with potentially fewer side effects. Obesity : By targeting adipose tissue or specific metabolic pathways, ADCs could offer new treatments for obesity and related metabolic disorders.

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Therapies Pharmaceutical Companies Disease Treatment 117

Chemical Biology and Drug Design

MAY 11, 2023

Abstract Parkinson's disease is among the most common forms of neurodegenerative illness, with present treatment being primarily symptomatic and frequently coming with substantial adverse effects. Therefore, this compound is considered a safe and effective therapeutic choice for neurodegenerative illnesses like Parkinson's disease.

Disease 100

Disease Research Clinical Trials Treatment 100

Broad Institute

JUNE 28, 2023

The findings, published today in Nature , could lead to new ways of guiding cancer treatment or developing targeted drugs. We began to think that these shorter events could give us signals about whether cancer cells were selecting for certain chromosome changes.”

DNA 122

DNA Medical Schools Treatment Research 122

FDA Law Blog: Biosimilars

JUNE 12, 2024

Gibbs — It’s been over a year and a half since Over-the-Counter (“OTC”) hearing aids became legal, and it’s not clear that they’ve made the difference in hearing loss treatment that Congress anticipated. (FDA FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

FDA 111

FDA Regulations Treatment Licensing 111

The Pharma Data

MAY 16, 2022

Food and Drug Administration (FDA) has lifted the clinical hold placed on the company’s Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). There is no cure for HIV or AIDS. About Lenacapavir.

FDA 52

FDA Treatment Science Therapies 52

The Pharma Data

FEBRUARY 25, 2022

If approved, rimegepant will be the first oral CGRP receptor antagonist in the EU, and the only migraine medication approved for both acute and preventive treatment. Pfizer is proud to have a strong footprint in Europe, which will help bring this important potential new treatment option to millions of adults in Europe living with migraine.”.

Treatment 52

Treatment Small Molecule FDA Approval Therapies 52

SCIENMAG: Medicine & Health

NOVEMBER 12, 2023

Low levels of Vitamin D have been shown to be associated with a higher risk of having a cardiac event, like a heart attack or stroke. For this reason, treatment by Vitamin D pills or injections are being investigated as a possible preventative method in these patients. Credit: Intermountain Health Low levels of Vitamin D […]

Treatment 83

Treatment 83

National Drug & Alcohol Research Centre Blog

FEBRUARY 12, 2024

Are these inexperienced drinkers with a low tolerance or seasoned users with long histories of alcohol problems, perhaps receiving treatment for alcohol dependence? What types of alcohol were being consumed before the fatal event?” Only seven people were in a treatment programme at the time they died.

Disease 110

Disease Treatment Drugs Research 110

Conversations in Drug Development Trends

AUGUST 10, 2023

As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. I was fortunate to have the opportunity to attend Psychedelic Science 2023 during the third week of June in Denver, Colorado.

Science 98

Science Clinical Trials Trials Clinical Research 98

PPD

JULY 29, 2024

The benefits of utilizing AI in clinical research Patient recruitment and diversity AI is increasingly being utilized in the recruitment process for clinical trials , aiming to connect individuals with potential benefits from investigational treatments.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

Eye on FDA

JULY 29, 2021

Perhaps no other decision by the Food and Drug Administration has garnered as much controversy, as the recent one to authorize the accelerated approval a new treatment for Alzheimer’s. Fundamental to any crisis response is the development and delivery of a narrative that offers explanation for the events. They are: What happened?

FDA 105

FDA Vaccine Clinical Trials Treatment 105

Drug Target Review

JULY 4, 2023

These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

The Pharma Data

MARCH 9, 2022

Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. million treatment courses delivered thus far and 30 million expected by July to help combat this devastating disease. Pfizer Inc.

Treatment 52

Treatment Pharmacokinetics Hospitals Trials 52

Chemical Biology and Drug Design

JULY 26, 2023

Abstract Noncoding RNAs (ncRNAs) are engaged in key cell biological and pathological events, and their expression alteration is connected to cancer progression both directly and indirectly. However, there are several limitations, including delivery, uptake, and short half-life, in the application of ncRNAs in cancer treatment.

Engineering 100

Engineering Therapies Cell Biology Drugs 100

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies 119

Therapies FDA FDA Approval Treatment 119

Broad Institute

DECEMBER 18, 2023

But a new path for bringing treatments to patients is starting to emerge. One of our long abiding concerns has been the pharmaceutical industry's progressive exit from R&D on treatments for central nervous system disorders apart from Alzheimer's and for large companies a nearly complete exit from new research in psychiatry.

Drug Development 130

Drug Development Clinical Trials Drugs Disease 130

ASPET

NOVEMBER 30, 2023

In this study, we evaluated the long-term efficacy of novel synthetic neurosteroids in preventing the development of chronic epilepsy and hyperexcitable ictal events in a rat OP model of SE. Similarly, the neurosteroid analog VX significantly attenuated SRS, discharges, HFOs, and ictal events.

Disease 100

Disease Therapies Treatment 100

The Pharma Data

MARCH 29, 2022

Application based on CheckMate -816, the only Phase 3 trial to demonstrate improved event-free survival and pathologic complete response with an immunotherapy-based combination in the neoadjuvant setting of NSCLC. Opdivo -based treatments have shown clinical benefit in four Phase 3 trials in earlier stages of cancer.

Treatment 52

Treatment Clinical Trials Trials Immune Response 52

The Pharma Data

MARCH 18, 2022

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab 1. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.1 months (95% CI: 3.4

Treatment 52

Treatment Trials FDA Approval Disease 52

The Pharma Data

FEBRUARY 24, 2022

Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D., Despite therapies in multiple drug classes, mortality remains high and treatment options for a broader range of patients are needed.

FDA Approval 52

FDA Approval FDA Treatment Hospitals 52

FDA Law Blog: Drug Discovery

MARCH 7, 2024

As a final example, current regulations require a sponsor of an investigational medical device to report to FDA (and others) “unanticipated” adverse events, which are defined in part as “serious,” and sponsors of investigational drugs to report to FDA serious and unexpected suspected adverse reactions.

Clinical Trials 105

Clinical Trials Trials FDA Regulations 105

The Pharma Data

APRIL 26, 2022

This approval follows the recent sNDA approval for Veklury for the treatment of non-hospitalized adult and adolescent patients who are at high risk of progression to severe COVID-19. For hospitalized pediatric patients who do not require invasive mechanical ventilation and/or ECMO, a 5-day treatment course is recommended.

Treatment 52

Treatment Hospitals Science Licensing 52

On Medicine

SEPTEMBER 12, 2023

Considering such findings, the United Nations Office on Drugs and Crime (UNODC) combined the TRT intervention with parenting strategies designed to enhance the carer’s capacity to support children through life events such as disasters, conflicts, and displacement. TRT + Parenting was trialled in Lebanon with Syrian families.

Trials 107

Trials Treatment Research Clinical Trials 107

SCIENMAG: Medicine & Health

JUNE 24, 2023

About The Study: Among people with insulin-naive type 2 diabetes, once-weekly icodec demonstrated superior HbA1c reduction to once-daily degludec after 26 weeks of treatment, with no difference in weight change and a higher rate of combined level two or three hypoglycemic events in the context of less than one event per patient-year exposure in both (..)

Treatment 68

Treatment 68

Drug Target Review

JULY 1, 2024

As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

MAY 27, 2022

The FDA’s decision is informed by the results of Pfizer’s nonclinical studies and a Phase 2a clinical study of ervogastat/clesacostat, which showed that treatment with ervogastat/clesacostat reduced liver fat with a favorable safety and tolerability profile. Pfizer Inc. NYSE: PFE) today announced the U.S.

Treatment 52

Treatment FDA Therapies Vaccine 52

The Pharma Data

FEBRUARY 22, 2022

Food and Drug Administration (FDA) for the adjunctive treatment of major depressive disorder (MDD) in patients who are receiving ongoing antidepressant therapy. In both of these studies, safety data were consistent with the established safety profile of cariprazine across indications, with no new safety events identified. or 3 mg/day).

Treatment 52

Treatment FDA Clinical Trials FDA Approval 52

Chemical Biology and Drug Design

APRIL 28, 2023

Geraniol (GE) by its antioxidant, anti-inflammatory, and anti-apoptotic properties ameliorated global ischemia-reperfusion induced cascade of events such as oxidative stress, apoptosis, and inflammation. Besides, GE treatment showed marked improvement in anxiety-related behavior and neuronal deficits in animals subjected to I/R injury.

Treatment 100

Treatment Research 100

ASPET

JANUARY 23, 2024

Most idiosyncratic drug reactions (IDRs) appear to be immune-mediated, but mechanistic events preceding severe reaction onset remain poorly defined. Moreover, treatment of drug-naïve THP-1 cells with clozapine-exposed EVs induced an inflammasome-dependent response, supporting a potential role for EVs in immune activation.

Immune Response 100

Immune Response Bioinformatics Regulations Drugs 100

Drug Target Review

JANUARY 2, 2024

This proved that patient treatment population and customised isolation of the stem cells’ identities and their bioenergetic organelle function should be considered when selecting the tissue source.

RNA 128

RNA Immune Response Therapies Disease 128

Covalent Modifiers

SEPTEMBER 19, 2023

No dose-limiting toxic effects or treatment-related deaths were reported. Treatment-related adverse events occurred in 127 patients (93%); grade 3 events occurred in 15 patients (11%) and a grade 4 event in 1 patient (1%). Among patients with NSCLC, a confirmed response was observed in 53.4% months (95% CI, 8.8

Pharmacokinetics 59

Pharmacokinetics DNA Treatment 59

The Pharma Data

MARCH 28, 2022

Kerendia ™ (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is approved for the treatment of chronic kidney disease and type 2 diabetes, excluding patients with end-stage renal disease or on dialysis. Finerenone is different to existing CKD in T2D treatments. In Japan, an estimated 13.3

Disease 52

Disease Treatment Clinical Trials Trials 52