Agency IQ

DECEMBER 1, 2023

What we expect European regulators to do in December 2023 In this new recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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The Pharma Data

DECEMBER 30, 2020

This regimen was shown in clinical trials to be safe and effective at preventing symptomatic COVID-19, with no severe cases and no hospitalisations more than 14 days after the second dose. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”.

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The Pharma Data

DECEMBER 29, 2020

Phase III BRIDGE open-label, switch-over clinical trial met key objectives for safety and efficacy. Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. CARMIEL, Israel and BOSTON , Dec. About Fabry Disease.

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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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Vial

FEBRUARY 23, 2024

A number of factors are contributing to this increase in popularity of digital patient portals, including the surge in telemedicine needs following the COVID-19 pandemic, technological advances enabling better integration of mobile-based health platforms, as well as federal regulations shifting to accommodate remote data accessibility.

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Drug Target Review

AUGUST 24, 2023

Her discoveries on the first-in-class RNA-based innate immune receptor agonist RGT100, built the foundation for the initiation of a Phase I clinical trial as well as the successful acquisition of Rigontec by MSD (known as Merck & Co. 2012 Feb 1;24(1):107-15. in North America) in late 2017. Biophysical Journal. 2019 May 22;10:1078.

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Codon

AUGUST 26, 2024

One large-scale clinical trial found that it only reduces the relative risk of death by about ten percent in hospitalized patients. Broad-spectrum antiviral drugs often have trouble finding pre-existing markets because regulators and consumers favor drugs that treat specific diseases, rather than drugs that have broad applicability.

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The Pharma Data

NOVEMBER 10, 2020

The trial is a dose-ranging, open-label study that will enroll 60 patients in the U.S. This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. 2012) Induction of immunological tolerance by oral anti-CD3. Clin Dev Immunol 2012, 425021. NEW YORK and LONDON, Nov. and Europe.

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NIH Director's Blog: Drug Development

JULY 20, 2017

Years of hard work, supported by the National Institutes of Health and the Cystic Fibrosis Foundation, painstakingly worked out the normal function of the protein that is altered in CF, called the cystic fibrosis transmembrane regulator (CFTR). Credit: Zhang & Chen, 2016, Cell 167, 1586–1597. About 30,000 Americans have CF.

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. That PTE application was submitted to the PTO on July 26, 2012. That did not happen.

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The Pharma Data

JANUARY 24, 2021

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial).

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Agency IQ

MAY 17, 2024

BY KIRSTEN MESSMER, PHD, RAC | MAY 15, 2024 10:23 PM CDT Background: Real-world data, real-world evidence and clinical studies A quick refresher on terminology: Real-world data (RWD) are data generated through general clinical practice or from other sources outside the controlled environment of clinical trials.

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Clinical Trials Trials Regulations Treatment 40

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

AUGUST 29, 2020

Basel , August 30, 2020 — Novartis today announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

JANUARY 19, 2024

The work could represent early steps toward modernizing one part of FDA’s regulation of this complicated product class. Since its creation in 2012, the generic drug user fee program (GDUFA) has focused on regulatory program improvements for complex generics.

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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] v] ERLEADA ® is being studied in five Phase 3 clinical trials. For more information about ERLEADA ® , visit www.ERLEADA.com. *© All rights reserved.

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Agency IQ

APRIL 8, 2024

FDA updates set the stage for broader use of harmonized standards for safety reporting Though long considered a top priority by regulators, the process to standardize and harmonize the submission of individual case safety reports (ICSRs) has been slow. Periodic Benefit-Risk Evaluation Reports ).

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The Pharma Data

JULY 8, 2021

Since the UK Biobank resource was opened for research use in April 2012, over 20,000 researchers from 90+ countries have been approved to use it and more than 2,000 peer-reviewed papers that used the resource have now been published.

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The Pharma Data

JANUARY 15, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. About Darzalex Faspro® In August 2012, Janssen Biotech, Inc. Among patients who received D-VCd, 74 percent were exposed for 6 months or longer and 32 percent were exposed for greater than one year.

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Agency IQ

NOVEMBER 20, 2023

The GVHD indication for use was the subject of a 2012 MDAC panel, which recommended classifying blood irradiators for this use as Class II, with special controls, and therefore eligible for the 510k pathway. I can’t imagine that someone is going to design a trial that is going to look at these things in such a small-use patient population.”

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Codon

MARCH 24, 2024

by the time Bancel made it over to Flagship, where Afeyan delivered his pitch: He wanted Bancel to work on a startup that had so far hired only a single staff scientist and conducted just one mouse trial. In response to this hysteria, regulation was aggressively tightened. . “It was about 6 p.m.

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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. & Barbadilla, A.

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Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s deep dive into kratom research and regulation here. ]

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The Pharma Data

APRIL 28, 2021

More information on these trials can be found at www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148). Phase 3 trials of SKYRIZI in psoriasis, Crohn’s disease, ulcerative colitis and psoriatic arthritis are ongoing. 2012 Feb;26(1):147-56. About SKYRIZI ® (risankizumab). Ann Dermatol Venereol.

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The Pharma Data

JUNE 18, 2021

1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. 1 The full, long-term results from the Phase 3 SELECT-PsA 2 clinical trial will be presented at the EULAR 2021 Virtual Congress. NORTH CHICAGO, Ill. 1 Results at week 56 were not multiplicity controlled.

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The Pharma Data

MAY 15, 2023

Since 2012, she serves as board member and currently as chair of the Audit Committee of Tecan Group, a Swiss listed company. Karen holds a PhD in Natural Sciences from ETH Zurich, and an MBA from IMD, both in Switzerland. She is also a board member at BBI Solutions, a UK based diagnostic reagents and a Novo Holdings company.

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The Pharma Data

AUGUST 3, 2021

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The Company has stopped enrollment in the Otezla arms of ongoing platform trials designed to evaluate the efficacy and safety of potential treatments for patients hospitalized with COVID-19.

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Codon

JUNE 26, 2023

The company behind the latter work, SNIPR BIOME , also recently announced results from a phase I clinical trial. A fifth clinical trial for base editing is now enrolling patients. It’s a phase I/II clinical trial for people with relapsed or refractory T-cell acute lymphoblastic leukemia. coli in mice. It will cost $3.2

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Codon

JUNE 26, 2023

The company behind the latter work, SNIPR BIOME , also recently announced results from a phase I clinical trial. A fifth clinical trial for base editing is now enrolling patients. It’s a phase I/II clinical trial for people with relapsed or refractory T-cell acute lymphoblastic leukemia. coli in mice. It will cost $3.2

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

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