The Premier Consulting Blog

OCTOBER 21, 2024

However, accelerated approval comes with a condition: sponsors must conduct confirmatory trials to verify the drug’s anticipated clinical benefits using robust outcome measures. Concerns have arisen over delays—sometimes spanning over 7–8 years—that may expose patients to risks before confirmatory trials are completed.

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Chemical Biology and Drug Design

OCTOBER 10, 2023

million people worldwide were living with HIV in 2021. Several agents are in clinical trials, including apricitabine, racivir, elvucitabine, doravirine, dapivirine, and elsulfavirine. Abstract Human immunodeficiency virus (HIV) causes acquired immunodeficiency syndrome (AIDS), a lethal disease that is prevalent worldwide.

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The Pharma Data

AUGUST 22, 2021

The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442. The trial included 5,197 participants in a 2:1 randomisation AZD7442 to placebo. The trial was conducted in 87 sites in the US, UK, Spain, France and Belgium.

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Drug Target Review

DECEMBER 16, 2024

In addition to this, I also chaired national trials evaluating an anti-GD2 antibody in pediatric osteosarcoma. Working with one of the largest cooperative groups in pediatrics, the Children’s Oncology Group , we ran quick signal-seeking trials to determine efficacy.

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Advarra

JUNE 20, 2023

Additionally, in 2021, a literature review estimated the average capitalized research and development (R&D) costs per new cancer medicine at between $944 million and $4.54 Innovation Organizations conducting oncology clinical trials face challenges distinct from the rest of the research community.

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The Pharma Data

SEPTEMBER 8, 2021

today announced that data reinforcing the potential of immunotherapies to impact clinical outcomes for patients will be featured at the European Society for Medical Oncology (ESMO) 2021 Virtual Congress from September 16-21. Dr. Camillo Porta. Thursday, September 16, 8:30 CEST.

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Vial

DECEMBER 5, 2023

NGS has expanded the scope of genomics research to include studies and clinical trials on rare genetic diseases, cancer genomics, microbiome analysis, infectious diseases, and population genetics. 2021) concluded that machine learning (ML) and network-based approaches can add valuable insights and build highly accurate models.

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The Pharma Data

AUGUST 30, 2021

Results from the Phase III EMPEROR-Preserved trial were presented today at the European Society of Cardiology Congress 2021 2 and published in The New England Journal of Medicine 1. 1 Trial participants were randomly assigned to empagliflozin 10 mg (n=2,997) or placebo (n=2,991) once daily.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are. Comments on the guidance are invited.

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The Pharma Data

AUGUST 27, 2020

Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immune response in elderly patients in an early-stage clinical trial. . Moderna started a large-scale Phase 3 trial last month that will test the vaccine’s safety and effectiveness on 30,000 people with results expected in October.

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The Pharma Data

SEPTEMBER 6, 2021

The favourable tolerability of eliapixant in this trial is consistent with earlier clinical findings. The selective mechanism of action of eliapixant appears to be translating into improved tolerability in clinical trials. Most were described as “a little” and “somewhat” bothersome, none described as “extremely” bothersome.

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On Medicine

SEPTEMBER 11, 2023

Background 5583 suicides were recorded in 2021 and about 1 in 5 people experience suicidal ideation (suicidal thoughts and plans) in their lifetimes. Secondly, we conducted a 6-month non-randomized feasibility trial and process evaluation in 12 community pharmacies (eight intervention and four control) in Lincolnshire, UK.

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The Pharma Data

OCTOBER 12, 2021

Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.

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Fierce BioTech

JUNE 8, 2023

The 2021 WCG Avoca Industry Survey was designed to gain deeper comprehension of respondents’ values, views, and experiences regarding diversity in clinical research execution and clinical research | Gain deeper comprehension of values, views, and experiences regarding diversity in clinical research execution and participation to effectively encourage (..)

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The Pharma Data

SEPTEMBER 2, 2021

The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. NEW YORK–(BUSINESS WIRE)– Pfizer Inc.

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The Pharma Data

AUGUST 31, 2021

The randomised, active-controlled global trial will enrol around 4,000 participants from a range of countries and will aim to evaluate GBP510’s safety and immunogenicity compared to an active comparator – the AstraZeneca/Oxford University COVID-19 vaccine.

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The Pharma Data

SEPTEMBER 28, 2021

Roche today announced data from across its growing neuromuscular portfolio at the planet Muscle Society (WMS) Virtual Congress 20 – 24 September 2021. Also, the info from SRP-9001 have helped to optimise the planning of the upcoming phase III clinical trial trial for DMD,” said Levi Garraway, M.D.,

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The Pharma Data

AUGUST 7, 2020

The partnership stipulates that Shenzhen Kangtai must raise its capacity to deliver 200 million by the close of 2021. Early data has shown that the candidate has successfully generated immune and T cell responses in patients, and Phase 2/3 trials kicking off back in May. There are around 1.4

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The Pharma Data

MAY 31, 2022

the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD). Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1

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DrugBank

AUGUST 9, 2024

Moreover, the probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved. reported in 2021. In 2021, an estimated 537 million adults were living with diabetes, a number projected to reach 643 million by 2030. billion in 2021, is projected to reach 231.7

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Broad Institute

OCTOBER 11, 2023

By then, a few cancer immunotherapies had entered clinical trials and only a handful had been approved by the FDA. As a first step, Manguso set his sights on treatments called PD-1 checkpoint inhibitors, which at the time had shown tremendous promise in clinical trials and would receive their first FDA approval in 2014.

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PLOS: DNA Science

MARCH 21, 2024

The history of gene therapy for MLD is compelling – DNA Science covered it for Rare Disease Day in 2021, here. A Long and Winding Diagnostic Road The story begins in 2011, with Alessandra Biffi, MD, head of the clinical trial for MLD at the San Raffaele Telethon Institute for Gene Therapy in Milan. She passed away in 2013.

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The Pharma Data

NOVEMBER 18, 2021

Six-months follow-up of prevention trial showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths with AZD7442. Separate treatment trial showed 88% reduced risk of severe COVID-19 or death when treated within three days of symptom onset.

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LifeSciVC

JANUARY 16, 2024

Whether trial design, execution, or otherwise, drug development even where there is precedent is a challenging road and should not be taken for granted. Additional trials (e.g., The incretins as a class also look interesting across a number of follow-on indications, as evidenced by clinical trials in these areas (below).

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Eye on FDA

AUGUST 4, 2021

When Breakthrough Therapy (BT) designation is granted, then the drug gets Fast Track status and receives more intensive guidance – which can begin as early as Phase I clinical trials. That said, BT would be a lagging indicator since it can be granted so early in the development process. Fewer meetings – more approvals.

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FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

The gene therapy demonstrated that it increased Factor IX (“FIX”) plasma levels at 6 months, the original primary endpoint of the Phase 3 trial. Again, this was despite the fact that subjects in the trial had demonstrated durable FIX activity to this point, with a mean of 41.5%

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LifeSciVC

APRIL 26, 2024

With just over 60 new biotechs raising their first round of financing, the sector’s company formation activity has slowed 50-60% from its historic peak in 2021. While also off from their peaks in 2021, there’s still significant aggregate venture funding flowing into the startup world by any historic metric.

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Drug Target Review

MARCH 28, 2024

1 Researchers have also observed a correlation between greater translatability of natural products and increased progression through clinical trials. He was an early employee of Recursion Pharmaceuticals, where he scaled their high-content imaging platform by multiple orders of magnitude before joining Enveda in 2021.

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The Pharma Data

NOVEMBER 8, 2021

Data from the analyses were presented at the American Society of Nephrology (ASN)’s Order Week 2021 in two oral donations and two late- breaking bills. Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “

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Codon

JULY 14, 2024

However, this dropped under 10% in 2021. However, the subsequent death of another patient thrust Denys into a contentious trial. Despite the high costs, researchers in Kyoto generated enough cultured platelets in 2022 to transfuse a 55-year-old woman for an initial human trial. Data from Rousseau G.F.

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Perficient: Drug Development

OCTOBER 4, 2023

In early 2021, our Life Sciences experts presented a Clinical Data Review Platform (CDRP) that demonstrated our strong industry perspective and expertise. PROJECT BACKGROUND Since 2008, Perficient has delivered multiple infrastructure platforming, commerce, and management consulting projects for this multinational corporation.

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Drug Target Review

SEPTEMBER 21, 2023

A novel drug, will be needful at this point as it will; help promote WHO’s roadmap for 2021-2030, provide much effective drugs and equal access to healthcare- as people living with onchocercomas will no longer worry about surgical removal of them. She was the valedictorian for the 2021 graduating class (6th congregation).

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Agency IQ

APRIL 19, 2024

Meet C3TI, FDA’s new clinical trial innovation hub On April 14, FDA announced that its Center for Drug Evaluation and Research (CDER) is launching a new clinical trial innovation hub, the CDER Center for Clinical Trial Innovation (C3TI). set specific standards and expectations for discrete components of clinical trials (e.g.,

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The Pharma Data

APRIL 22, 2023

UC Davis Health researchers have dosed the second participant in their clinical trial looking to identify a potential cure for HIV utilizing CAR T-cell therapy. The trial is the first-in-human clinical study investigating the duoCAR T-cell therapy for the treatment of HIV. The novel study uses immunotherapy.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data. In August 2021, FDA issued a press release announcing the denial of 55,000 flavored e-cigarette applications en masse. FDA also directed manufacturers to produce detailed marketing plans.

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The Pharma Data

NOVEMBER 23, 2021

Roche moment blazoned that new data from its expansive haematology portfolio will be presented at the American Society of Hematology (ASH) Annual Meeting and Exposition from 11-14 December 2021.

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FDA Law Blog: Biosimilars

NOVEMBER 27, 2023

After a brief trial, on Friday Nov. First, as is more common under the CPSC, the Gree Companies agreed to pay civil penalties for failing to make the required reporting to the CPSC. At the time, in 2016, the Gree Companies’ settlement for $15.45 million in civil penalties set a new record for CPSC.

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