FDA Approval, Laboratories, Pharmacokinetics and Trials

De-risking drug discovery with predictive AI

Broad Institute

JULY 17, 2024

Still, more than 90 percent of drug candidates fail in clinical trials, with even more that never make it to the clinical stage. Together, the tools estimate how a drug may impact diverse outcomes of interest to drug developers: general cellular health, pharmacokinetics, and heart and liver function. A fourth is in the works.

Pharmacokinetics

Pharmacokinetics Molecular Biology Drugs FDA

First-in-human clinical trial for a vaccine to treat opioid use.

The Pharma Data

SEPTEMBER 7, 2021

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by researchers at the University of Minnesota Medical School.

Clinical Trials

Clinical Trials Vaccine Trials Medical Schools

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

The Premier Consulting Blog

APRIL 15, 2024

We will use the term, nonclinical, to refer to any in vitro, ex vivo, or animal study conducted to support any stage of research and development of a new drug, such as proof-of-concept pharmacology studies through Good Laboratory Practice (GLP) toxicology studies. neurotoxicity) that require special assessments.

FDA

FDA Pharmacokinetics Laboratories FDA Approval

FDA approves first in vivo gene insertion programme in infants

Drug Discovery World

APRIL 10, 2024

iECURE has been given the go-ahead to begin US trials of its investigational gene editing-based therapy in newborn males with neonatal onset Ornithine Transcarbamylase (OTC) deficiency. Secondary objectives are to assess the pharmacokinetics and efficacy of ECUR-506.

FDA Approval

FDA Approval FDA Pharmacokinetics Laboratories

Where is the promise for plant-based medicines? Part 1: Cannabis

Drug Discovery World

AUGUST 3, 2023

Even still, these approved drug products require a licensed healthcare provider’s prescription. With these exceptions, no other cannabis, cannabis-derived, or cannabidiol (CBD) products are FDA-approved and therefore on the market 1. Across the border in Canada, cannabis is legal for both recreational and medicinal purposes.

Clinical Trials

Clinical Trials Regulations Production FDA

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19.

FDA

FDA Clinical Trials Vaccine Trials

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

The Pharma Data

AUGUST 19, 2021

Food and Drug Administration (FDA) approval for patients with locally advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, based on data showing an ORR of 40 percent (95 percent CI, 29 – 51) and median duration of response of 11.1 The most common Grade 3 or 4 laboratory abnormalities (?2%)

Treatment

Treatment FDA Approval Pharmacokinetics FDA

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

The Pharma Data

MAY 4, 2021

Abnormal Laboratory Values: Evaluate at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. It is approved in the U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity.

Therapies

Therapies Hospitals FDA Approval Long-Term Care Facilities

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

The Pharma Data

APRIL 11, 2021

” In the Phase 1/2 LIBRETTO-001 trial, 32 adult patients with 12 unique RET fusion-positive advanced cancer types were enrolled by the efficacy cutoff date of September 19, 2020 (with follow-up through March 19, 2021). Retevmo was approved based on the Phase 1/2 LIBRETTO-001 trial’s endpoints of ORR and DoR.

Research

Research Treatment Therapies Trials

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

The Pharma Data

DECEMBER 5, 2020

Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients. NASDAQ: REGN) today announced updated data for REGN5458, a BCMAxCD3 bispecific antibody, from the Phase 1 portion of a Phase 1/2 trial in patients with relapsed or refractory (R/R) multiple myeloma. Regeneron Pharmaceuticals, Inc.

Production

Production Trials Treatment Pharmaceuticals

Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints.

The Pharma Data

AUGUST 30, 2021

Results reinforce well-established safety profile of Dupixent – the first ever biologic medicine for atopic dermatitis currently approved for patients as young 6 years old. The trial demonstrated similar safety results to the known safety profile of Dupixent in atopic dermatitis. Yancopoulos, M.D., In 2016, the U.S.

Trials

Trials Disease Clinical Trials Treatment

Fortis Life Sciences leads the way in custom antibody discovery

Drug Discovery World

DECEMBER 13, 2023

Custom antibodies can be developed for pharmacokinetic assays and biodistribution assays, supporting therapeutic development by giving researchers data about the behaviour of their novel therapeutic in vivo. Caplacizumab, for the treatment of a rare blood clotting disease, achieved FDA approval in 2019 2.

Science

Science Small Molecule Laboratories Engineering

Improving quality control for CAR T cell therapies

Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. Measuring the pharmacokinetics of CAR T cells.

Therapies

Therapies Virus Treatment Engineering

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). Clinical status including laboratory parameters should be monitored and appropriate therapy should be initiated. Global Head, Janssen Research & Development, Johnson & Johnson.

FDA Approval

FDA Approval Treatment RNA FDA

Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

The US FDA Modernisation Act 2.0., puts an end to the previous mandate that all drugs need to be tested on animals prior to human clinical trials. Prior to this European Union Parliament, in 2021, voted for animal testing phase out.

Animal Testing

Animal Testing Clinical Trials Pharmaceutical Companies FDA

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

The Pharma Data

JANUARY 26, 2021

Lilly’s chief scientific officer and president of Lilly Research Laboratories. In the trial, the safety profile of bamlanivimab and etesevimab together was consistent with observations from other Phase 1, Phase 2 and Phase 3 trials evaluating these antibodies. INDIANAPOLIS, Jan. have reached record highs.

Hospitals

Hospitals Treatment Long-Term Care Facilities Trials

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

A giant dataset about the rat brain, and how neurons connect to each other, was collected and pooled together from 20 different research laboratories. ” Clinical trials are underway. Read Off the coast of Marseille, this autonomous laboratory is unmanned and runs experiments 2,450 meters beneath the ocean’s waves.

DNA

DNA RNA Engineering Licensing

FDA for approval to treat VTE and to prevent VTE in children

The Pharma Data

JUNE 28, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections, dietary restrictions, and regular laboratory monitoring. EINSTEIN-Jr. About the EINSTEIN-Jr. Study The randomized, open-label phase III EINSTEIN-Jr.

FDA

FDA Clinical Trials Treatment Therapies

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Patients in the trial received either a combination of ERLEADA ® and ZYTIGA ® plus prednisone (combination arm) or placebo and ZYTIGA ® plus prednisone (control arm). [i] Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. All rights reserved.

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Trials

Drug Discovery Digest

De-risking drug discovery with predictive AI

First-in-human clinical trial for a vaccine to treat opioid use.

Trending Sources

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

FDA approves first in vivo gene insertion programme in infants

Where is the promise for plant-based medicines? Part 1: Cannabis

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

RYBREVANTTM (amivantamab-vmjw) in the Treatment of Patients with Advanced Non-Small.

Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries | Eli Lilly and Company

Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Gastrointestinal and Other Cancers at 2021 American Association for Cancer Research (AACR) Annual Meeting

Regeneron’s BCMAxCD3 Bispecific Antibody (REGN5458) Shows Deep and Durable Responses in Patients with Heavily-pretreated Multiple Myeloma in Phase 1

Dupixent® (dupilumab) pivotal trial meets all primary and secondary endpoints.

Fortis Life Sciences leads the way in custom antibody discovery

Improving quality control for CAR T cell therapies

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Advanced 3D cell-based technologies

New Data Show Treatment with Lilly’s Neutralizing Antibodies Bamlanivimab (LY-CoV555) and Etesevimab (LY-CoV016) Together Reduced Risk of COVID-19 Hospitalizations and Death by 70 Percent

Codon Digest: Injected Gene Editors

FDA for approval to treat VTE and to prevent VTE in children

Janssen Presents Results from Phase 3 ACIS

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