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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The Pharma Data

SEPTEMBER 19, 2020

Results from the Phase III IMpassion131 study, evaluating Tecentriq in combination with paclitaxel for the treatment of people with metastatic TNBC and whose tumours expressed PD-L1, did not meet its primary endpoint of progression-free survival . There was no significant difference in OS between the treatment groups in the ITT population.

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The Pharma Data

JULY 22, 2021

The study period was 12 months and included two arms; the prior on-demand (OD) group included patients previously taking OD VWF and the switch group included patients previously taking prophylactic plasma-derived von Willebrand factor (pdVWF) treatment [LPB0128]. The sABR was reduced by 91.5%

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Laboratories Production Treatment Disease 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

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.

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Pharmacokinetics Treatment Production Small Molecule 52

New Drug Approvals

SEPTEMBER 29, 2024

2018 ; Ding et al., Both were reversed by treatment with COR388 ( 2020 AAIC abstract ). According to a company press release and a poster presentation at the 2018 CTAD conference, healthy adults received 25, 50, or 100 mg COR388 or placebo every 12 hours for 10 days; AD patients took 50 mg or placebo every 12 hours for 28 days.

Small Molecule 62

Small Molecule DNA Disease Trials 62

Drug Discovery World

JULY 8, 2024

Two such FDA-approved RNA aptamers are pegaptanib and avacincaptad pegol, indicated for the treatment of macular degeneration.

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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. As a leader in the field, UNITY was listed on the NASDAQ stock exchange in 2018. SUZHOU, China and ROCKVILLE, Md. , 22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK),

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Clinical Development Disease Treatment Licensing 40

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?

Small Molecule 59

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

Metabolite Tales Blog

JANUARY 23, 2024

Patented active metabolites Gepirone’s metabolites have been patented for “the manufacture of a medicament for the treatment of psychological disorders” [9]. Veozah (Fezolinetant): A Promising Non-Hormonal Treatment for Vasomotor Symptoms in Menopause. Pharmacokinetics and Metabolism of Nirmatrelvir. Health Sci Rep. 6(10):e1610.

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Small Molecule FDA Approval FDA Pharmacokinetics 52

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.

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Pharmaceutical Companies Treatment Clinical Trials Trials 52

Metabolite Tales Blog

MARCH 1, 2023

9 The evidence here is that treatment with P450 inhibitors removed the toxic effects seen in the compounds of interest. 2018, 26, 965-972 [link] 4a Pharmaceutics, 2022, 14, 1001 [link] 5 Phys. 2018, 61, 5, 2041–205 [link] 9 ACS Chem. 2010, 75, 9, 3141–3143 [link] 22 Clin Pharmacokinet. 1980, 8, 34-38 [link] 4 J.

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Metabolic Stability Pharmacokinetics Drugs Science 52

The Pharma Data

APRIL 8, 2021

today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. Alzheimer’s Disease (AD). P6: Neuromuscular Disorders and Clinical Trials.

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Clinical Trials Trials Disease Nurses 52

Metabolite Tales Blog

APRIL 4, 2023

3 Metabolism differences at steady state Adagrasib, Mirati’s irreversible KRASG12C inhibitor for treatment of non-small cell lung cancer is mainly metabolised by CYP3A4. link] [2] Zhang and Tang, 2018. 2018 Sep;8(5):721-732. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest. Br J Pharmacol.

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Small Molecule FDA Approval FDA Drugs 52

The Pharma Data

NOVEMBER 9, 2020

CAB LA and oral FTC/TDF were both well tolerated and most adverse events were mild or moderate in severity and largely balanced between both treatment arms. Since this safety signal was raised in May 2018, recent data has noted a decline in the risk. The pharmacokinetic tail—will this be a significant risk for drug resistance?

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Trials Pharmacokinetics Drugs Therapies 52

The Pharma Data

AUGUST 22, 2021

12)AZD7442 is being studied in a comprehensive clinical trial programme for both prevention and treatment of COVID-19 in over 9,000 participants. Ongoing trials include TACKLE COVID-19(13), a Phase III treatment trial in an outpatient setting and collaborator treatment trials in outpatient and hospitalised settings.

Trials 52

Trials Virus Vaccine Pharmacokinetics 52

Drug Discovery World

FEBRUARY 15, 2023

The number of new cases recorded between 2016 and 2018 was 375,400, with 167,142 deaths caused by cancer between 2017 and 2019. Another revolutionary discovery was the elucidation of the role of IL2 in T cell growth and activation in the 1970s, that later paved the way for the treatment of patients with metastatic melanoma and renal cancer.

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Agency IQ

FEBRUARY 23, 2024

That passage is referred to as pharmacokinetics (PK) and incorporates four important phases – absorption, distribution, metabolism, and excretion (ADME). Last week, the EMA published a finalized reflection paper on the topic of investigating PK in people with obesity, a project that has been in the works since 2018.

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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. Among the 21 infants enrolled in Part 1 of the FIREFISH study, the median duration of treatment was 14.8

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The Pharma Data

MARCH 20, 2023

These latest data make us confident that the improvement observed during the first year of treatment is sustained during four years which contrasts with the decline we would observe in the absence of treatment.” No treatment-related AEs led to withdrawal from the study. Evrysdi was well-tolerated over the four-year time period.

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Pharmacokinetics Treatment Clinical Trials Trials 40

The Pharma Data

MARCH 16, 2021

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. The study suggests that gains in motor function observed with Evrysdi treatment at month 12 continued to improve or were maintained at month 24 across primary and secondary endpoint measures.

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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.” 9) AZD7442 is being studied in a comprehensive clinical trial programme for both forestallment and treatment of COVID-19 in over parties. 2018; 37 (9) 886-892. Griffin MP, et al. Antimicrob Agents Chemother. Yu XQ, 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