FDA Law Blog: Biosimilars

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

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Drug Target Review

OCTOBER 17, 2024

While its involvement in the do-not-eat-me signal from cancer has inspired therapeutic development of this pathway for oncology, the function of the innate immune checkpoint we identified in 2009 1 extends to both innate and adaptive immune responses. Biomarkers are the holy grail of clinical trials. 2009 Mar 5;323(5922):1722–5.

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The Pharma Data

DECEMBER 7, 2020

But studies exploring its impact on them remain scant, an analysis of clinical trials over the past decade shows. based clinical trials investigating interventions for high blood pressure between 2009-2018, just 52 were exclusively in Black people. There hasn’t been much of a change.”

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The Pharma Data

SEPTEMBER 30, 2020

These are key goals for a pandemic drug, and Jefferson blamed this on the product being approved through trial design loopholes. . billion in revenue in 2009 as the H1N1 flu spread. . billion on stockpiling the drug. billion on stockpiling the drug. The act allows individuals to bring claims on behalf of the government.

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FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP). Throughout the SIUU Guidance, FDA refers to studies and analyses , suggesting that publications may cover more than a description of an adequate and well-controlled clinical trial.

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The Pharma Data

MARCH 4, 2021

Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm 3 were reported in Olumiant clinical trials. Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. 10x ULN were observed in patients in Olumiant clinical trials. Increases of ALT ?5x

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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

DECEMBER 11, 2020

Though results of animal studies sometimes differ in humans, the findings bolster the scientific basis for mitochondrial replacement therapy (MRT) in human clinical trials, the study authors said. ” Though clinical trials are ongoing in the United Kingdom and Greece, the U.S. ” The findings were published online Dec.

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New Drug Approvals

SEPTEMBER 29, 2024

Findings Two Phase 1 trials of atuzaginstat were completed by June 2019. A Phase 2/3 trial (GAIN) evaluating a 48-week course of COR388 in 643 people with mild to moderate AD began in April 2019. This trial involves 93 sites in the U.S. Periodontitis has been linked epidemiologically to cognitive impairment, and P. and Europe.

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Vial

MAY 1, 2024

The landscape of medical research is currently in the midst of an exciting transition wherein technology has rapidly become a critical tool for clinical trial management and patient data collection. in 2010 to 11.4% in 2020 to enable continuous remote monitoring of real-world patient health data. in 2010 to 11.4%

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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.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(1). FDORA § 3209(a)(2).

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The Pharma Data

AUGUST 1, 2021

The approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the Saphnelo clinical development programme, including two TULIP Phase III trials and the MUSE Phase II trial. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009.

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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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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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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.

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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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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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New Drug Approvals

AUGUST 21, 2023

7] A one-year trial did not demonstrate a significant benefit on lung density in moderate-to-severe emphysema secondary to severe α(1)-antitrypsin deficiency. [8] 18] In December 2022, the FDA declined to approve palovarotene for the fibrodysplasia ossificans progressive without additional clinical trial data. [19] 22 October 2009.

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The Pharma Data

FEBRUARY 22, 2022

He is co-founder and non-executive board member of the Hartwig Medical Foundation (large scale DNA analyses) and is a board member of the Center for Personalized Cancer Treatment and leads several innovative precision oncology clinical trials. Emile Voest obtained a PhD in medicine from the University of Utrecht.

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FDA Law Blog: Biosimilars

AUGUST 29, 2024

3582 —well before the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) established the biosimilar biological product licensure pathway, and years before the U.S. Supreme Court declined to hold, in FTC v. Actavis, Inc. , 2233 (2013) , that so-called reverse payment settlement agreements are presumptively unlawful.

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Drug Target Review

APRIL 8, 2024

Identifying patients who are at high risk for relapse would likely help us isolate those high risk group of patients for more innovative clinical trials. He is the Principal Investigator for the NCI funded ALCHEMIST trial to study the role of erlotinib in patients with early-stage EGFR mutated lung cancer. Coulter Jr.

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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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Vial

FEBRUARY 23, 2024

However, this was addressed years later with the passing of the American Recovery and Reinvestment Act (ARRA) of 2009 by President Obama, particularly the Health Information Technology for Economic and Clinical Health Act (HITECH) Act within the ARRA.

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Drug Target Review

FEBRUARY 28, 2024

Preclinical research on γδ T cells has made great strides since the cells were first identified in the 1980s, with γδ T-cell therapies from several companies, including IN8bio, now in or nearing clinical trials for various cancers. from 2003 to 2006, covering the biotechnology and life-science tools sectors.

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Drug Target Review

JUNE 29, 2023

It’s great that we are in clinical trials, and we are helping a certain number of patients, but if you don’t make it to the market and all that involves, then you haven’t really won because you think of all those patients that you’re no longer serving if you don’t get to that end goal.

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Drug Target Review

JUNE 21, 2023

Strikingly, a strong genetic link between target and disease biology is emerging as a predictor for success in clinical trials. Why Clinical Trials Stop: The Role of Genetics. 2009 Nov 27;326(5957):1231-5. Sci Transl Med. 2017 Mar 29;9(383):eaag1166. Doi: 10.1126/scitranslmed.aag1166. PMID: 28356508; PMCID: PMC6321762.

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Advarra

FEBRUARY 22, 2024

Assessing and reporting adverse events (AEs) in clinical trials is critical to ensuring the study is as safe as possible and the participants have the most up to date information so they can decide whether to continue their participation in the research study. Who Should Assess AEs in Clinical Trials? regulations.

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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.

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The Pharma Data

OCTOBER 21, 2020

The pooled analysis examined 1,744 participants across 16 countries currently taking long-acting cabotegravir and rilpivirine as part of the regimen’s ongoing global clinical development programme of six studies, which includes the phase IIb/IIIb LATTE-2, ATLAS, ATLAS-2M, FLAIR, POLAR, and CUSTOMIZE clinical trials. About ViiV Healthcare.

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Drug Target Review

SEPTEMBER 26, 2023

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. References Blinova K, Stohlman J, Vicente J, Chan D, Johannesen L, Hortigon-Vinagre MP, et al. Neurotoxicology. 2010 Aug;31(4):331–50. Drug Discov Today.

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LifeSciVC

DECEMBER 13, 2022

During the spring of 2009, when the markets hit bottom, Schrödinger’s Ramy Farid and I co-founded the company, then called Project Troubled Water, and we incubated it in the Atlas offices. In August 2021, we launched our Phase 2b clinical trial and recently announced the top line data for ‘4858 from that trial in early November 2022.

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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., Minerva Med.

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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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The Pharma Data

NOVEMBER 9, 2021

”As one of the longest safety trials for a JAK asset in this complaint, these data can help healthcare providers and people living with rheumatoid arthritis in better understanding OLUMIANT when considering treatment options that can be used for dragged ages of time.” Taylor,M.D.,Ph.D., See the full Prescribing Information then.

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National Drug & Alcohol Research Centre Blog

MAY 30, 2022

With Australia failing to meet its 2009-Preventative Health Taskforce target of a 10%-or-lower smoking rate by 2020 it’s clear that increasing quit smoking rates in low-SES populations is important for Australia to meet future health targets and lower the burden of disease caused by tobacco smoking.

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The Pharma Data

APRIL 6, 2021

In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases. 10x ULN were observed in patients in Olumiant clinical trials. Increases of ALT ?5x

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