New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 30 January 2018. “Safety, tolerability, and pharmacokinetic evaluation of single- and multiple-ascending doses of a novel kappa opioid receptor antagonist LY2456302 and drug interaction with ethanol in healthy subjects” Journal of Clinical Pharmacology.

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Drug Target Review

OCTOBER 3, 2024

These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. 2018 Dec 5;11(1):178–90. Journal of Molecular Biology. 2011 Oct 1;413(1):261–78.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

New Drug Approvals

SEPTEMBER 29, 2024

2018 ; Ding et al., 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. Epub 2018 Oct 3 PubMed. Epub 2018 Jan 30 PubMed.

Small Molecule 62

Small Molecule DNA Disease Trials 62

Drug Target Review

OCTOBER 4, 2023

7 These inhibitors have faced challenges such as dose-limiting toxicity and poor pharmacokinetics, but geldanamycin ADCs have demonstrated increased survival in mice. 1 , 33–43 (2018). 9 Others, like psymberin, have been used as ADC payloads, with a β-glucuronide linker to target CD-30-positive and CD-70-positive malignancies.

Small Molecule 126

Small Molecule Drugs Immune Response Targeted Protein Degradation 126

The Pharma Data

DECEMBER 13, 2020

The companies filed in December 2019, and included analytical, pharmacokinetic and clinical data, as well as pharmacology and toxicology data from two clinical trials. The drug is also being evaluated in combination with checkpoint inhibitors, and in patients with HER2+ gastroesophageal cancer.

FDA 52

FDA Biosimilars Clinical Trials Licensing 52

The Pharma Data

AUGUST 22, 2021

Safety, Tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. 2018; 37(9): 886-892. Griffin MP, et al. Antimicrob Agents Chemother. 2017; 61(3): e01714-16. Yu XQ, et al. Antimicrob Agents Chemother. Domachowske JB, et al.

Trials 52

Trials Vaccine Virus Pharmacokinetics 52

The Pharma Data

MARCH 13, 2021

Lanadelumab, under the tradename TAKHZYRO ® , received its first approval for the prevention of HAE attacks in patients 12 years and older in 2018 and is now available in more than 20 countries with additional regulatory submissions ongoing worldwide. Interactions. No dedicated drug-drug interaction studies have been conducted.

Treatment 52

Treatment Pharmacokinetics Drugs Production 52

Vial

MARCH 15, 2024

Examples of vendors include: Laboratories : CROs often collaborate with specialized laboratories for various purposes, such as sample analysis or pharmacokinetic studies, among others. These collaborations with external vendors are aimed at accessing specialized expertise, technologies, or resources that they may not have in-house.

Clinical Trials 52

Clinical Trials Compliance Trials Laboratories 52

The Pharma Data

NOVEMBER 8, 2020

The submission includes data from the ENLIGHTEN clinical development program in schizophrenia, and pharmacokinetic (PK) bridging data comparing ALKS 3831 and Zyprexa (olanzapine), to support an indication for schizophrenia. Celgene acquired it in 2018 from bluebird bio, who originally developed the therapy.

FDA 52

FDA Trials Therapies Pharmacokinetics 52

The Pharma Data

AUGUST 19, 2021

In 2018, Janssen Biotech, Inc. entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib. **In 2018, Janssen Biotech, Inc. 8] , [9] , [10] , [11] , [12]. **In entered into a license and collaboration agreement with Yuhan Corporation for the development of lazertinib.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Pharmacokinetics and Metabolism of Nirmatrelvir. Health Sci Rep. 6(10):e1610. link] [8] Patent EP3428168A1. link] [9] Patent EP1242061B1. link] [10] FDA prescribing information for gepirone.

Small Molecule 52

Small Molecule FDA Approval FDA Pharmacokinetics 52

Metabolite Tales Blog

APRIL 4, 2023

link] [2] Zhang and Tang, 2018. 2018 Sep;8(5):721-732. The Pharmacokinetics, Metabolism, and Clearance Mechanisms of Abrocitinib, a Selective Janus Kinase Inhibitor, in Humans. Insights into drug metabolism by cytochromes P450 from modelling studies of CYP2D6-drug interactions. Br J Pharmacol. Acta Pharm Sin B.

Small Molecule 52

Small Molecule FDA Approval FDA Drugs 52

The Pharma Data

DECEMBER 21, 2020

As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME. As a leader in the field, UNITY was listed on the NASDAQ stock exchange in 2018.

Clinical Development 40

Clinical Development Disease Treatment Licensing 40

Metabolite Tales Blog

MARCH 1, 2023

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. 2006 , 34, 145-51 [link] 3 Drug Metab. 1980, 8, 34-38 [link] 4 J. Food Drug Anal. 2000, 2, 195-201 [link] 6 Biochem. 1966 98, 266-277 [link] 7 Metabolites.

Metabolic Stability 52

Metabolic Stability Pharmacokinetics Drugs Science 52

Metabolite Tales Blog

DECEMBER 13, 2023

8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality. PMID: 9733662. [8] 8] The Genetic Polymorphism UGT1A4*3 Is Associated with Low Posaconazole Plasma Concentrations in Hematological Malignancy Patients Receiving the Oral Suspension. Antimicrob Agents Chemother.

Small Molecule 59

Small Molecule Metabolic Stability Treatment Pharmacokinetics 59

The Pharma Data

SEPTEMBER 19, 2020

References [1]World Health Organization: Globocan 2018 – Breast Cancer Factsheet. Secondary endpoints include OS, event-free survival, disease-free survival and quality of life measures. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. 2] Yao H et al. Oncotarget.

Treatment 52

Treatment Disease Therapies Pharmaceuticals 52

The Pharma Data

JULY 22, 2021

1 The pharmacokinetics (PK) of VWF:ristocetin cofactor (VWF:RCo) and FVIII pharmacodynamics (PD) [PB0917] were also studied and presented at the congress. 13 Hemophilia A is more common than hemophilia B; in 2018, hemophilia A affected about 173,711 people, whereas hemophilia B affected about 34,289 people worldwide.

Treatment 52

Treatment Laboratories Production Disease 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. FDA on February 8, 2018. [vi] 2 ERLEADA ® received U.S. To date, more than 10,000 patients worldwide have been treated with ERLEADA ®. ERLEADA ® is taken orally, once daily, with or without food.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

JULY 6, 2021

Population pharmacokinetic and pharmacodynamic modeling data to characterize the antithrombin (AT) lowering dynamics in hemophilia patients treated with fitusiran will be shared in a poster presentation. These data support the revised fitusiran dose and dosing regimen implemented in the ongoing adult and adolescent studies. a Sanofi Company.

Therapies 52

Therapies Pharmacokinetics RNA Treatment 52

The Pharma Data

NOVEMBER 9, 2020

Safety during pregnancy and breastfeeding When information was made available in May 2018 regarding Dolutegravir (DTG), which is an integrase inhibitor in the same class of drug as cabotegravir, that there was a possible association. Since this safety signal was raised in May 2018, recent data has noted a decline in the risk.

Trials 52

Trials Pharmacokinetics Drugs Therapies 52

The Pharma Data

OCTOBER 6, 2021

Safety, tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial elixir prefusion F-targeting monoclonal antibody with an extended half- life, in healthy grown-ups. 2018; 37 (9) 886-892. Griffin MP, et al. Antimicrob Agents Chemother. 2017; 61 (3) e01714-16. Yu XQ, et al. Antimicrob Agents Chemother. Wang L et al.

Pharmacokinetics 52

Pharmacokinetics Trials Government Vaccine 52

The Pharma Data

APRIL 8, 2021

EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Food and Drug Administration (FDA) approved EVRYSDI for the treatment of SMA in adults and children 2 months of age and older. About OCREVUS ® (ocrelizumab).

Clinical Trials 52

Clinical Trials Trials Disease Therapies 52

The Pharma Data

FEBRUARY 25, 2021

FIREFISH, an open-label, two-part pivotal study, was designed to assess Evrysdi safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) in patients aged 1 to 7 months with Type 1 SMA. Enrollment for Part 2 was completed in November 2018. mg/kg for Part 2. The study met its primary endpoint.

Pharmacokinetics 52

Pharmacokinetics FDA Approval Treatment Disease 52

Agency IQ

AUGUST 16, 2024

Lykos also registered an additional open-label Phase 1 pharmacokinetics study of midomafetamine and metabolites in patients with moderate hepatic impairment to understand if a dose adjustment is necessary in that population. This study is planned to start in late 2024 and conclude in late 2025.

FDA 40

FDA Trials Therapies Regulations 40

The Pharma Data

MARCH 16, 2021

Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Enrollment for Part 2 was completed in November 2018. At this time, Evrysdi has been approved in seven countries and submitted in 57, including the EU 27 and Norway and Iceland.

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

The Pharma Data

MARCH 30, 2021

Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation in 2019. Enrolment for Part 2 was completed in November 2018. This approval is applicable to all 27 European Union member states, as well as Iceland, Norway, and Liechtenstein. The study met its primary endpoint.

Treatment 52

Treatment Clinical Trials Pharmacokinetics Trials 52

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.

Drugs 40

Drugs Clinical Trials Pharmacokinetics Drug Development 40

The Pharma Data

SEPTEMBER 27, 2020

Risdiplam was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Enrolment for Part 2 was completed in November 2018. The FDA approved Evrysdi for the treatment of SMA in adults and children 2 months of age and older.

Pharmacokinetics 52

Pharmacokinetics FDA Approval Treatment Clinical Trials 52

Metabolite Tales Blog

NOVEMBER 13, 2024

References [1] Pharmacokinetics, disposition, and biotransformation of the cardiac myosin inhibitor aficamten in humans. 2] Pharmacokinetics, mass balance, tissue distribution, metabolism, and excretion of [14C]aficamten following single oral dose administration to rats. Drug Metab Pharmacokinet. Pharmacol Res Perspect.

Pharmacokinetics 59

Pharmacokinetics Small Molecule Production Clinical Development 59