The Pharma Data

OCTOBER 21, 2020

In the midst of the global pandemic, the analysis found no antiretroviral therapy interruptions across the entirety of the ongoing clinical development programme for long-acting cabotegravir and rilpivirine. Of those participants who transitioned back to injectables, the median duration of oral therapy was 51 days.

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The Pharma Data

NOVEMBER 9, 2020

Image: Copyright © 2009-2020 Merck Sharp & Dohme Corp., and Canada, announced along with Eisai today that it has new investigational data demonstrating positive top-line results from the Phase III KEYNOTE-581/CLEAR trial (Study 307). a subsidiary of Merck & Co., Kenilworth, N.J., All rights reserved. Source link.

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Drug Target Review

APRIL 8, 2024

How have recent advancements in immune checkpoint blockade therapy affected outcomes for primary NSCLC? Dr Govindan : Even though immunotherapy and chemotherapy given after surgery improve the overall survival, as Dr Cote said, many may not need those therapies and a good number of them recur despite post operative systemic therapies.

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Hospitals Therapies Clinical Trials Molecular Biology 52

Conversations in Drug Development Trends

FEBRUARY 22, 2023

Panelists will answer questions such as: What are the greatest challenges holding patients back from enrolling in trials? I joined the FARA staff in 2009, and our team built a nationwide series of bike rides called rideATAXIA to raise funds for research. I have participated in many trials and studies.

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Disease Clinical Trials Trials Treatment 52

Drug Target Review

SEPTEMBER 26, 2023

Early detection of neurotoxicity induced by potential new therapies is a major challenge, and hiPSC-neuronal cells may provide a solution. Dr Rockley previously completed an MSc in Cancer Pharmacology and have experience in clinical research from an oncology clinical trial coordinator role. 2009 Sep;14(17–18):876–84.

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New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] hours following a single dose of 10 mg, which supported the 4 mg to 25 mg dosages that aticaprant is being explored at in clinical trials. [13] 16] [17] The compound was first patented in 2009. [18] 2] Aticaprant is taken by mouth. [1]

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

DrugBank

JUNE 27, 2023

Modern advances in “omics,” as well as biomarker development, clinical trial design, and mathematical modelling (including artificial intelligence) have revolutionized our ability to precisely define or “stratify” patient populations, splitting them into groups based on their characteristics. 5 , e1000433 (2009).

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Codon

MARCH 28, 2023

In 2009, the USC professor received millions from the Defense Advanced Research Projects Agency, or DARPA, to build a device that plugs into the brain and enhances memory recall. There was nothing left over for human trials, until an opportune call came from Elon Musk’s secretary. The first project, REMIND, began in 2009.

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Engineering Research Science FDA Approval 52

The Pharma Data

NOVEMBER 11, 2020

Additional information about the GLEAM study (also called Study KS301P104) and the GLIMMER study (also called Study KS301P105) can be found on www.clinicaltrials.gov under Trial Identifiers NCT04611152 and NCT04603937, respectively ( [link] and [link] ). About the BEACON Study. About the DAZZLE Study. About KSI-301.

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Science Treatment Disease Engineering 40

Drug Target Review

JUNE 21, 2023

Enabling the systematic discovery of these largely uncharted targets can be a valuable opportunity for development of novel therapies. Genetic-based therapeutics hold significant promise in the clinic Despite the growing number of genes linked to human disease, the proportion of genes targeted by approved therapies remains low.

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Drug Target Review

JUNE 29, 2023

I think the cell-therapy field has evolved a lot – and is continuing to do so – in the time I’ve been working with this. Regarding the NY-ESO programme that we worked on, I started work on that in 2002 before we even knew that we were going to do cell therapy. I mean, I think cell-therapy is an great place to be.

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The Pharma Data

AUGUST 1, 2021

AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009. 7,8,9,10,11.

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Trials Therapies Disease Treatment 52

The Pharma Data

OCTOBER 14, 2020

Food and Drug Administration (FDA) to begin a Phase I clinical trial of hAd5-COVID-19, the company’s novel COVID-19 vaccine candidate that targets both the inner nucleocapsid (N), engineered to activate T cells, and outer spike (S) protein, engineered to activate antibodies against the coronavirus (SARS-CoV-2). i,ii,iii,iv.

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The Pharma Data

JUNE 24, 2021

today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The TALAPRO-3 trial will enroll approximately 550 men with DDR-deficient mCSPC across 285 clinical trial sites in 28 countries. About TALAPRO-3 Trial.

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Clinical Trials DNA Trials Treatment 52

PLOS: DNA Science

OCTOBER 17, 2024

The new drug is taken with miglustat , which FDA approved for use in NPD3 in 2009. A Well-designed Clinical Trial Small patient populations complicate testing treatments for a rare disease. The clinical trial for the new drug, Miplyffa, cleverly used a crossover design that compares the same participant with and without the treatment.

Disease 52

Disease FDA Approval Drugs Treatment 52

Codon

APRIL 9, 2023

” — Harold Morowitz 🔥 Ten Amazing Things (that happened this week…) A CAR-T therapy was tested in 27 children with neuroblastomas. Read Ocular stress enhances contralateral transfer of lenadogene nolparvovec gene therapy through astrocyte networks. Molecular Therapy. Gene Therapy. McGrady N.R.

Therapies 52

Therapies RNA Engineering Vaccine 52

The Pharma Data

JUNE 18, 2021

The FDA’s decision is based on evidence from Pfizer’s clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. On September 20, 2018, Pfizer announced the U.S. Clin Infect Dis.

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Vaccine FDA Approval FDA Disease 52

The Pharma Data

APRIL 8, 2021

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. .

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Hospitals FDA Approval Laboratories Treatment 52

The Pharma Data

APRIL 24, 2021

In 1999, Novartis launched the first fixed-dose Artemisinin-based Combination Therapy (ACT) and in 2009, the first dispersible pediatric ACT developed in partnership with Medicines for Malaria Venture (MMV). The grant will support African trials of a combination comprising KAF156 and lumefantrine in a new once-daily formulation.

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Clinical Trials Treatment Trials Disease 52

The Pharma Data

OCTOBER 9, 2021

The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated diseases. A decision from the U.S. FDA is anticipated in late 2022.

Treatment 52

Treatment FDA Approval FDA Pharmaceutical Companies 52

New Drug Approvals

DECEMBER 3, 2022

1] [6] Navitoclax entered clinical trials , [1] [6] and showed promise in haematologic cancers , but was stalled when it was found to cause thrombocytopenia (severe loss of platelets ), which was discovered to be caused by the platelets’ requirement for Bcl-xL for survival. [1] nM, and 197.8 nM, respectively. doi : 10.1038/ncomms11190.

Small Molecule 52

Small Molecule Clinical Trials Laboratories Regulations 52

The Pharma Data

MAY 4, 2021

ViiV Healthcare was granted Breakthrough Therapy Designation (BTD) for long-acting cabotegravir in November 2020 based on efficacy and safety results from HPTN 083. [1] ViiV Healthcare was granted Breakthrough Therapy Designation (BTD) for long-acting cabotegravir in November 2020 based on efficacy and safety results from HPTN 083. [1]

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The Pharma Data

NOVEMBER 8, 2020

and Shionogi Limited as shareholders, today announced that an independent data safety monitoring board (DSMB) recommended the early unblinding of the HIV Prevention Trials Network (HPTN) 084 study evaluating the safety and efficacy of investigational, long-acting, injectable cabotegravir for HIV prevention in women.

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Trials Treatment Science Research 40

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

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FDA Science Biosimilars Regulations 40

Codon

JULY 21, 2024

As the biotechnologist Alex Telford writes , “Without mouse models, we may never have developed polio and meningitis vaccines, organ transplants, GLP-1 drugs, gene therapies , or any other number of transformative treatments.” Another part of providing research animals with a good life is granting them a good death.

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The Pharma Data

DECEMBER 3, 2020

The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator assigned treatment (IAT) in transplant recipients with CMV infection refractory or resistant to existing antiviral treatments (i.e.,

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Treatment Pharmaceutical Companies Therapies Virus 52

The Pharma Data

MAY 4, 2021

INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. It is approved in the U.S.

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Therapies Hospitals Treatment FDA Approval 52

The Pharma Data

MARCH 4, 2021

Baricitinib has received Breakthrough Therapy designation from the U.S. and more than 70 countries as a treatment for adults with moderate to severe active RA and in the European Union and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy.

Trials 52

Trials Treatment Therapies Clinical Trials 52

The Pharma Data

MARCH 17, 2022

Merck (NYSE: MRK), known as MSD outside the United States and Canada, the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced results from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS.

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Therapies Clinical Trials Disease Treatment 52

The Pharma Data

MAY 4, 2021

Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients OLUMIANT ® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

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Licensing Licensing Therapies Laboratories 40

The Pharma Data

OCTOBER 29, 2020

Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo. Test patients for latent TB before initiating Olumiant and during therapy.

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Therapies Treatment Disease Clinical Trials 52

The Pharma Data

APRIL 6, 2021

and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis (RA) and was recently approved in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. See the full Prescribing Information here.

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Treatment Drugs Clinical Trials Therapies 52

Codon

MARCH 14, 2023

In 2009, a small group of Dutch biologists rounded up some lab mice, stabbed them with needles, and harvested their blood. None of them were beneficial, and “eight of these compounds ultimately failed in clinical trials, which together involved thousands of people.” A third experiment found no effect.

DNA 52

DNA Laboratories Engineering Animal Testing 52

The Pharma Data

JULY 29, 2021

The most frequently used therapies were corticosteroids (79% of patients, mostly dexamethasone) and remdesivir (19% of patients). Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials. No new safety signals potentially related to the use of baricitinib were identified.

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Hospitals FDA Laboratories Treatment 52

The Pharma Data

AUGUST 3, 2021

announced today results from an additional cohort of 101 adult patients from the COV-BARRIER trial. In the COVID-19 clinical trials, adverse drug reactions in the safety population occurring in ? The most frequently used therapies were corticosteroids (79% of patients, mostly dexamethasone) and remdesivir (19% of patients).

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Hospitals FDA FDA Approval Licensing 52

Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. Molecular factors Molecular markers, such as protein expression and signalling pathway activation, also guide therapy choices.

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Clinical Trials Trials Drugs Drug Development 52

The Pharma Data

FEBRUARY 25, 2021

7 In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (1-15 years of age and 16-65 years of age). At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. “If approved in the U.S., Genome Announc. Tonteri E, et al.

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