The Pharma Data

JANUARY 3, 2021

United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application. Food and Drug Administration cleared Investigational New Drug Application. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc.

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Agency IQ

SEPTEMBER 15, 2023

The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and tests requires for covered OTC products to be generally recognized as safe and effective (GRASE). developing or amending a monograph) or sponsor-initiated operations (e.g.,

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The Pharma Data

NOVEMBER 18, 2020

This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. ‘SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.

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The Pharma Data

NOVEMBER 5, 2021

About the study NCT03832114 is a Phase II, open- marker, two cohort,non-randomized study assessing the efficacity, safety and pharmacokinetics of iptacopan in cases with C3 glomerulopathy (C3G) ( cohort A) and cases who have experienced order transplantation and have posterior C3G rush in the transplanted organ ( cohort B).

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PPD

MAY 11, 2023

Additionally, the European Medicines Agency offers guidance specific to the clinical investigation of medicinal products in pediatric populations. Historically, the elderly have been under-represented in clinical trials that include study participants 18 years of age and older.

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The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium. The Company plans to initiate a Phase 2 trial within the next several months.

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The Pharma Data

APRIL 11, 2023

Bayer will present the first clinical Phase 1 results on aryl hydrocarbon receptor (AhR) inhibitor BAY 2416964, the company’s most advanced Immuno-Oncology program. The company has the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer.

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The Pharma Data

NOVEMBER 9, 2021

We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”. See below forU.S. Important Safety Information. Long- term Treatment With Vemlidy in HBV.

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The Pharma Data

NOVEMBER 8, 2020

Based on the feedback from our Type A meeting in February, we conducted additional product testing with the goal of addressing the Chemistry, Manufacturing and Controls deficiencies discussed in the CRL.”. “We have been encouraged by our interactions with the FDA following our CRL and are pleased to resubmit our Zimhi NDA,” said Dennis J.

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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The Pharma Data

AUGUST 29, 2020

3,4 LNP023 is currently in clinical development for PNH and a number of renal conditions with complement system involvement where significant unmet needs exist, including IgA nephropathy, complement 3 glomerulopathy (C3G), atypical hemolytic uremic syndrome and membranous nephropathy.

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The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways. and reduce the overall clinical pharmacology program.

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Agency IQ

AUGUST 16, 2024

FDA solidifies its advice on dose optimization for oncology products Just over a year after it released the draft guidance, the FDA has finalized its guidance on dose optimization for oncology products. In early-stage development of traditional cytotoxic oncology drugs (i.e.,

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The Pharma Data

JULY 21, 2021

There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties.

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Drug Target Review

OCTOBER 3, 2024

These assays may include pharmacokinetic (PK) assays, which provide information on the drug’s properties, and immunogenicity assays for the detection of anti-drug antibodies (ADA), which can lead to adverse events and reduced efficacy. References Köhler G, Milstein C. Journal of Molecular Biology. 2011 Oct 1;413(1):261–78.

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The Pharma Data

APRIL 11, 2021

There are no data on the presence of selpercatinib or its metabolites in human milk or on their effects on the breastfed child or on milk production. If coadministration cannot be avoided, follow recommendations for CYP2C8 and CYP3A substrates provided in their approved product labeling. About Lilly Oncology.

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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes. switching studies).

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The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Imeglimin , Poxel’s first-in-class lead product, targets mitochondrial dysfunction. NASH Investor Event Information.

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The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

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The Pharma Data

JULY 12, 2021

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir.

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Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Speak with an expert today to discuss your next clinical program. Watch the webinar.

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The Pharma Data

APRIL 7, 2022

Sisunatovir significantly reduced viral load in a phase 2 RSV human challenge study in healthy adults and is currently in phase 2 clinical development in infants. The development program for sisunatovir is expected to continue in both adult and pediatric populations. Food and Drug Administration (FDA).

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Agency IQ

AUGUST 9, 2024

By Laura DiAngelo, MPH | Aug 2, 2024 6:30 PM CDT A refresher on FDA’s Diversity Action Plan (DAP) guidance: In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. What programs or products need a DAP? Read AgencyIQ’s extensive analysis of the draft guidance here.]

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The Pharma Data

JANUARY 17, 2021

The companies announced in January 2019 a collaboration agreement to develop, manufacture and commercialize SPR206 in the Territory. SPR206 is in clinical development as an innovative option for the treatment of multi-drug resistant (MDR) Gram-negative bacterial infections. SHANGHAI , Jan. SHANGHAI , Jan. ” About SPR206.

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The Pharma Data

DECEMBER 21, 2020

Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA). ALLSCHWIL, Switzerland, Dec.

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The Pharma Data

SEPTEMBER 1, 2020

Pregnancy outcomes in the ozanimod multiple sclerosis clinical development program. Inhibition of drug transporter breast cancer resistance protein has no effect on the pharmacokinetics of major active metabolites of ozanimod. Author: Minton. Presentation Number: P1133. Presentation Topic: Reproductive Aspects and Pregnancy.

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Alta Sciences

APRIL 17, 2024

Our preclinical and bioanalytical experts have extensive experience in leading-edge technologies to support sponsors in the advancement of their gene therapy products. Gene Therapy resources Watch our on-demand webinar, “ Nonclinical Safety Assessment for Gene Therapy Products ”. Asia, and Europe.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product. Pivotal (i.e.,

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The Pharma Data

DECEMBER 14, 2020

The product is designed for the prevention and treatment of COVID-19, along with related coronaviruses. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced.

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PPD

JUNE 20, 2023

Mix and match: With the flexibility of FSPs, adjust your mix of services and resources for a clinical product, marketing product or a diverse portfolio of assets, whether you need to fill small gaps in services or support large-scale programs with dedicated capacity management across functions.

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The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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The Pharma Data

APRIL 8, 2021

Roche’s Chief Medical Officer and Head of Global Product Development. “We Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA. P15: MS Clinical Trials and Therapeutics. Spinal Muscular Atrophy (SMA).

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The Pharma Data

JANUARY 10, 2021

10, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create product candidates that address unmet medical needs, will provide an update on Vision 3×3 and the company’s 2021 key milestones at the 39 th Annual J.P. COPENHAGEN, Denmark, Jan.

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Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Momelotinib inhibits ACVR1/ALK2, decreases hepcidin production, and ameliorates anemia of chronic disease in rodents. Pharmacokinetics and Metabolism of Nirmatrelvir.

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Agency IQ

FEBRUARY 2, 2024

EMA finalizes clinical anticancer therapeutic guidance update In a newly finalized revision, the EMA’s guideline covering all aspects of clinical development of anticancer therapeutics has expanded its already broad scope. The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996.

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The Pharma Data

MAY 7, 2021

The review of the data is being carried out by the EMA’s Committee for Medicinal Products for Human Use (CHMP). About the Sotrovimab Clinical Development Program. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). population demographics.

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