Agency IQ

SEPTEMBER 15, 2023

Background on oral phenylephrine as a nonprescription nasal decongestant Phenylephrine is an alpha-1 adrenergic agonist that is approved as a nonprescription oral treatment for temporary relief of nasal congestion , sinus congestion and pressure. The committee also made recommendations regarding pharmacokinetic and safety assessments.

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Science FDA Clinical Trials Pharmacy 40

Drug Discovery World

JULY 8, 2024

While mRNA vaccines and RNA interference therapies have garnered much attention, a new class of RNA therapeutics known as aptamers is gaining momentum, particularly to address acute diseases. By silencing transthyretin (TTR) mRNA, patisiran decreases the production of TTR protein, the molecule responsible for causing the disease.

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RNA Small Molecule Vaccine FDA Approval 147

The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. The therapeutic dose of pirfenidone approved by the US Food and Drug Administration (FDA) for the treatment of IPF is 801 mg three times a day.

Pharmacokinetics 52

Pharmacokinetics Treatment Production Small Molecule 52

New Drug Approvals

SEPTEMBER 13, 2024

2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] nM vs. 24.0

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Treatment Pharmacokinetics Clinical Trials Pharmaceuticals 62

Drug Discovery World

AUGUST 10, 2022

Until about 25 years ago, the best treatment option for someone with blood cancer was either toxic radiation and chemotherapy or a bone marrow transplant that posed additional life-threatening risks to the patient 1. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2.

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The Pharma Data

DECEMBER 21, 2020

UBX1325 is developed from BM-962, a Bcl-xL inhibiting compound licensed to UNITY by Ascentage Pharma for the treatment of age-related diseases. UNITY is a biotechnology company developing therapeutics to extend healthspan by slowing, halting or reversing diseases of aging. SUZHOU, China and ROCKVILLE, Md. ,

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Clinical Development Disease Treatment Licensing 40

The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

Clinical Trials 52

Clinical Trials Trials Disease Nurses 52

Metabolite Tales Blog

DECEMBER 13, 2023

The pyrazole in a drug compound developed by LEO as an oral IL-17A protein-protein interaction modulator for the treatment of psoriasis and other inflammatory disorders is susceptible to N -glucuronidation. 22(5):803-11; [link] [10] Glucuronidation and UGT isozymes in bladder: new targets for the treatment of uroepithelial carcinomas?

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Small Molecule Metabolic Stability Treatment Pharmacokinetics 59

Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. Ultimately, flexibility in dual-payload ADC development means better treatments could reach patients sooner.

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Small Molecule Drugs Immune Response Targeted Protein Degradation 126

The Pharma Data

FEBRUARY 8, 2021

No statistically significant difference was demonstrated for secondary endpoints including overall survival (OS), time to initiation of cytotoxic chemotherapy, chronic opioid use, and pain progression between treatment arms. Grade 3/4 treatment emergent adverse events (TEAEs) were reported in 63.3 percent in the control arm.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Trials 52

Metabolite Tales Blog

JANUARY 23, 2024

The drug is therefore contraindicated in cases where severe renal impairment or end‐stage renal disease has been confirmed, as well as in combination with CYP1A2 inhibitors [7]. Patented active metabolites Gepirone’s metabolites have been patented for “the manufacture of a medicament for the treatment of psychological disorders” [9].

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

Drug Discovery World

FEBRUARY 15, 2023

Cancer is a complex heterogenous multistep disease characterised by uncontrolled cell proliferation combined with a dysregulated immune response. The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019.

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The Pharma Data

AUGUST 22, 2021

We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines. We look forward to sharing further data from the AZD7442 Phase III clinical trial programme later this year.” About AstraZeneca.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

Agency IQ

FEBRUARY 23, 2024

Obesity itself contributes to multiple long-term consequences , including high blood pressure and high cholesterol, which in turn increase the risk of heart disease. That passage is referred to as pharmacokinetics (PK) and incorporates four important phases – absorption, distribution, metabolism, and excretion (ADME).

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Drugs Clinical Trials Pharmacokinetics Drug Development 40

The Pharma Data

MARCH 30, 2021

Basel, 30 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has approved Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.

Treatment 52

Treatment Clinical Trials Pharmacokinetics Trials 52

The Pharma Data

FEBRUARY 25, 2021

FIREFISH Part 1 data show treatment with Evrysdi at 12 months helped 90% of these infants survive without permanent ventilation and 33% sit without support, a key motor milestone not normally seen in the natural course of the disease. fold from baseline in the high-dose cohort at 12 months. months at the time of analysis.

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Pharmacokinetics FDA Approval Treatment Disease 52

The Pharma Data

MARCH 20, 2023

Professor of Paediatric Neuromuscular Diseases at the MDUK Oxford Neuromuscular Centre. This trial included people with Type 2 and 3 SMA, including patients with advanced disease. Without treatment, natural history data show that patients with Type 2 or 3 SMA typically show a decline in motor function over time.

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Pharmacokinetics Treatment Clinical Trials Trials 40

The Pharma Data

MARCH 16, 2021

SUNFISH Part 2 study population includes broad range of ages and disease severities, representing a real-world spectrum of people living with Type 2 or 3 SMA. Evrysdi is the first and only at home SMA treatment approved by the FDA, and has proven efficacy across adults, children and infants 2 months and older.

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Pharmacokinetics Treatment Clinical Trials Disease 52

The Pharma Data

OCTOBER 6, 2021

We look forward to participating AZD7442 data for the treatment of COVID-19 thereafter this vintage.” About AZD7442 AZD7442 is a combination of two LAABs-tixagevimab (AZD8895) and cilgavimab (AZD1061)- decided from B- cells bestowed by convalescent cases after SARS-CoV-2 disease. 2018; 37 (9) 886-892. Griffin MP, et al.

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Pharmacokinetics Government Trials Vaccine 52

The Pharma Data

SEPTEMBER 27, 2020

In August, the FDA approved Evrysdi for the treatment of SMA in adults and children 2 months and older. After two years of treatment with Evrysdi, 71% (12/17 vs. 10/17 at 1-year) of infants achieved a CHOP-INTEND* score of 40 points or more and all infants increased their score from month 12 to month 24. months and the oldest was 45.1

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Pharmacokinetics FDA Approval Treatment Clinical Trials 52