Alta Sciences

AUGUST 28, 2023

The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied.

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PPD

JULY 29, 2024

AI can also predict the likelihood of a serious adverse event before administering the investigational product at an individual level, allowing patients to be categorized by their risk profile. A high-risk participant can be even excluded from the study based on the severity of the adverse event.

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The Pharma Data

FEBRUARY 12, 2022

Nasdaq GILD) moment blazoned new data from an interim analysis of its ongoing, Phase2/3 single arm, open- marker study to estimate the safety, tolerability and pharmacokinetics of Veklury ® (remdesivir) in pediatric cases rehabilitated with COVID-19 with periods ranging from 28 days to lower than 18 times. Gilead Lores,Inc.

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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. Journal of Molecular Biology. 2011 Oct 1;413(1):261–78. Harth S, Ten Haaf A, Loew C, et al.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

However, these types of trials can lead to small, non-comparative safety data sets and do not have the ability to use time-to-event endpoints. Biomarker Endpoints Biomarker endpoints are another helpful way to assess the potential efficacy of both initial dose-finding studies and dose-optimization studies.

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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.

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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. Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Pfizer Inc.

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Treatment Pharmacokinetics Hospitals Trials 52

The Pharma Data

JANUARY 31, 2021

The Phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of intravenously administered PNT001 in healthy adult volunteers. Three non-serious Grade 1 adverse events were determined to be related to PNT001 or placebo, and all resolved without sequelae.

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The Pharma Data

APRIL 13, 2022

Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives.

Treatment 52

Treatment Pharmacokinetics Vaccine Production 52

Advarra

JUNE 20, 2023

Participants may balk at certain protocol requirements, such as extended visits for pharmacokinetic (PK) measurements. Assessing Endpoints A final hurdle faced in oncology trials is trial endpoints, or the event(s) or outcome(s) being measured to determine whether the study intervention is safe and effective.

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Trials Clinical Trials FDA Approval Therapies 52

The Pharma Data

MARCH 13, 2021

1 Most treatment-emergent adverse events (98.5%) were mild to moderate in severity. None of the increases in aPTT in patients treated with TAKHZYRO were associated with abnormal bleeding adverse events. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected.

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The Pharma Data

NOVEMBER 17, 2021

The EC’s blessing of VUMERITY is grounded on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA to establish bioequivalent exposure of monomethyl fumarate, the active metabolite, and reckoned in part on the well- established long- term efficacity and safety profile of TECFIDERA. Encyclopedically, an estimated2.8

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Drug Target Review

JUNE 12, 2023

What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties? ISM6331 is a Pan-TEAD inhibitor with novel scaffold with good IP space, discovered by Chemistry42.

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Metabolic Stability Clinical Trials Small Molecule Pharmacokinetics 92

The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 12 years of age with severe hemophilia A.

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Treatment Pharmacokinetics Therapies FDA 52

Drug Target Review

SEPTEMBER 25, 2024

At TOLREMO, we have developed a proprietary modular phenotypic screening platform that leverages transcriptional reprogramming events associated with non-genetic resistance to deliver new chemical scaffolds and identify novel resistance regulators. Available from: [link] 8.Boni Journal of Clinical Oncology [Internet].

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The Pharma Data

APRIL 14, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together and bamlanivimab alone. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

AUGUST 22, 2021

The LAAB was well tolerated and preliminary analyses show adverse events were balanced between the placebo and AZD7442 groups. Safety, Tolerability, and pharmacokinetics of MEDI8897, the respiratory syncytial virus prefusion F-targeting monoclonal antibody with an extended half-life, in healthy adults. Griffin MP, et al. Yu XQ, et al.

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Trials Virus Vaccine Pharmacokinetics 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.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec. Source link.

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The Pharma Data

MAY 5, 2021

It also provided supporting pharmacokinetic data demonstrating the opioid antagonist’s safety and efficacy. . A total of 197 patients in the study arm had at least one of the composite endpoint events, compared with 312 patients in the placebo arm. New indications.

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Drug Target Review

JULY 1, 2024

SRP-001 is a novel non-opioid pain relief candidate that works centrally in the brain, offering robust pharmacokinetics without the adverse effects of current medications. In Phase I clinical trials, SRP-001 showed no serious adverse events among 56 healthy volunteers, highlighting its safety.

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Treatment Clinical Trials Therapies Molecular Biology 59

The Pharma Data

MARCH 9, 2021

The primary endpoint was the maximum change in plasma HIV-1 RNA during parts one and two while secondary endpoints measured safety, tolerability, and pharmacokinetic (PK) parameters. There were no adverse events (AEs) leading to discontinuation and no deaths reported. log 10 and -2.0

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LifeSciVC

APRIL 24, 2024

If adverse events are anticipated, it is important to understand gene dosage for such an effect (e.g., The ideal target is one where modulation will not drive adverse phenotypes in healthy individuals, which is important if one intends on trialing in healthy volunteers in Phase 1 but also gives comfort for chronic target modulation.

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Agency IQ

AUGUST 11, 2023

As a result of these RRAs, we’ve identified unreported adverse events, gathered information to add products that appear to be violative to import alerts, evaluated the status of companies correcting issues from a previous inspection and helped the agency make regulatory decisions for product premarket submissions.” ( Emphasis added ).

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The Pharma Data

SEPTEMBER 7, 2021

Volunteers will be closely monitored for several weeks on inpatient units at Columbia University Irving Medical Center and at Clinilabs to look for adverse events and determine their response to oxycodone after vaccination, before studying their drug behavior on an outpatient basis. The study plans to enroll up to 45 volunteers.

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The Pharma Data

JANUARY 26, 2021

Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 Serious adverse events were reported at a similar frequency in the bamlanivimab and etesevimab together and placebo groups. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

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Hospitals Treatment Trials Long-Term Care Facilities 52

The Pharma Data

AUGUST 19, 2021

The majority of treatment-related adverse events (AEs) were Grade 1-2. All events were Grade 1-2. 1 Disease response was evaluated using overall response rate (ORR), per Response Evaluation Criteria in Solid Tumors Version 1.1* (RECIST v1.1) as the primary endpoint. 1 The median time to first response was 4.1 months (range, 1.6–9.9).

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Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

APRIL 16, 2021

Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab and etesevimab together. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19. Adverse Events.

Treatment 52

Treatment Hospitals Long-Term Care Facilities Virus 52

The Pharma Data

SEPTEMBER 26, 2021

The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA.

Treatment 40

Treatment Clinical Trials Virus Pharmacokinetics 40

The Pharma Data

OCTOBER 14, 2021

Presentations at ECTRIMS include: IgG Immune Response to SARS-CoV-2 Vaccination in People Living With Multiple Sclerosis Within MS PATHS (P652) Flushing and Flushing-Related Adverse Events With Diroximel Fumarate in Patients With Relapsing-Remitting Multiple Sclerosis: Results from the Phase 3 EVOLVE-MS-2 Study (P673) Early Data Suggest Diroximel Fumarate (..)

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Vaccine Therapies Immune Response Disease 52

The Pharma Data

JANUARY 3, 2021

The Phase 1/2 clinical trial will primarily investigate the safety and tolerability of INZ-701 and characterize its pharmacokinetic and pharmacodynamic profile, including plasma pyrophosphate (PPi) and other biomarker levels, to establish a recommended dosing regimen for further clinical development.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

The Pharma Data

APRIL 11, 2021

In this cohort, the most common treatment-emergent adverse events of any grade (?20%) No patients in this cohort discontinued treatment due to treatment-related adverse events. Serious, including fatal, hemorrhagic events can occur with Retevmo. 3 hemorrhagic events occurred in 2.3% of patients treated with Retevmo.

Research 52

Research Therapies Treatment Trials 52

The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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The Pharma Data

APRIL 7, 2021

The EC’s approval of the SC route of administration for TYSABRI is based on data from the DELIVER and REFINE studies, which showed comparability to the Q4W IV administration of 300mg TYSABRI in efficacy, pharmacokinetic and pharmacodynamic profiles.

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Clinical Trials Treatment Virus Pharmacokinetics 52

The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. In this study, which is being conducted at 10 U.S.

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