The Pharma Data

APRIL 11, 2021

The data were presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, held virtually April 10-15, 2021. was approved by the European Commission in February 2021. chief medical officer, oncology at Lilly. Retevmo (marketed as Retsevmo ® outside the U.S.) About LIBRETTO-001.

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The Pharma Data

OCTOBER 15, 2020

The study, which involves approximately 50 patients with the rare liver and lung disease, raised concerns about the experimental treatment’s safety and pharmacokinetic profile. That trial is continuing to enroll and dose patients, and results are expected in the first half of 2021.

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The Pharma Data

DECEMBER 14, 2020

The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. Given a positive outcome of the approved Phase 1 study, the company intends to initiate Phase 2 by the end of 2021.

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New Drug Approvals

SEPTEMBER 10, 2024

“A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK-041 in healthy participants and patients with stable schizophrenia” British Journal of Clinical Pharmacology. Cilia, Jackie; Hitchcock, Stephen (12 August 2021). X H NMR (500 MHz, DMSO-i¾) δ ppm 1.40 (d, J=6.8 Hz, 3 H), 4.98 (quin, J=7.1

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Drug Target Review

SEPTEMBER 25, 2024

2021 Oct 11 [cited 2024 Sep 4];13(20):5081. 2021 Apr [cited 2024 Sep 4];2(4):377–91. A phase 1, first-in-human, open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of TT125-802 in patients with advanced solid tumors. Cancers [Internet]. Available from: [link] 5.Passaro Nature Cancer [Internet].

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Drug Target Review

JUNE 12, 2023

What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties? 2021 – and a robust pipeline that includes 3 AI-designed drugs (for IPF, COVID-19 and cancer) currently in clinical trials.

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PerkinElmer

JANUARY 7, 2022

There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. 2021 [cited 16 December 2021]. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved.

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The Pharma Data

MARCH 5, 2021

We are focused on quickly advancing the pirtobrutinib development program, including through a series of Phase 3 studies that will be initiated over the course of 2021.” Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. About Pirtobrutinib (LOXO-305).

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. President and Chief Executive Officer of SCYNEXIS.

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Hospitals Pharmacokinetics Treatment Trials 52

The Pharma Data

JANUARY 17, 2021

Spero plans to initiate additional Phase 1 studies to assess the penetration of SPR206 into the pulmonary compartment and pharmacokinetics in subjects with renal impairment in 2021. Spero will assign relevant SPR206 patents to Everest Medicines in Greater China, South Korea and certain Southeast Asian countries. SHANGHAI , Jan.

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Drug Target Review

SEPTEMBER 19, 2023

Prior to this European Union Parliament, in 2021, voted for animal testing phase out. Viable in vitro alternatives to animal Models: The European Medicines Agency has launched the new approach methodologies in 2021 promoting the use of animal experiment alternatives in drug discovery and development. The US FDA Modernisation Act 2.0.,

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The Pharma Data

JANUARY 31, 2021

1, 2021 12:00 UTC. The Phase 1 study was designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of intravenously administered PNT001 in healthy adult volunteers. Study showed PNT001 was well-tolerated at dose levels that may provide potential therapeutic effect. CAMBRIDGE, Mass.–(

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The Pharma Data

SEPTEMBER 8, 2021

today announced that data from its migraine portfolio will be presented at the International Headache Congress 2021, held jointly this year by the International Headache Society and the European Headache Federation, from September 8-12. AbbVie abstracts and presentation details for IHC 2021 are outlined below. September 11, 2021.

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The Pharma Data

JUNE 7, 2022

The randomized, double-blind, comparative clinical study compared the efficacy, safety, pharmacokinetics and immunogenicity of RIABNI versus rituximab reference product (RP) in patients with moderate to severe RA. Safety, pharmacokinetics and immunogenicity of RIABNI were similar to rituximab RP.

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The Premier Consulting Blog

JANUARY 31, 2023

Pharmacokinetic and systemic exposure data is also important to consider. URL: [link] The ICHS1 Regulatory Testing Paradigm of Carcinogenicity in Rats: Status Report 2021. Epub 2021 Nov 1. chronic studies or transgenic mouse studies), hormonal effects, genotoxicity, and immune modulation (Figure 1). J Toxicol Pathol.

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The Pharma Data

JANUARY 3, 2021

04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. The Company expects to enroll the first subject in the first half of 2021 and provide preliminary safety and biomarker data in the second half of 2021. BOSTON, Jan. About the INZ701-101 Phase 1/2 Clinical Trial of INZ-701 in Adults with ENPP1 Deficiency.

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New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. World Health Organization (2021). PMC 10540057. PMID 37768671. Diep, John K.; Yu, Rosie Z.; Viney, Nicholas J.; December 2022).

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The Pharma Data

AUGUST 19, 2021

Oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2021 World Conference on Lung Cancer (WCLC) shows evidence that the bispecific mechanism of action for RYBREVANT TM can provide anti-tumor activity against either EGFR-mutated or MET-mutated non-small cell lung cancer. 4] , [5] , [6].

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Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

JANUARY 19, 2021

20, 2021 11:00 UTC. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented, “The clearance of our CTA application for ALS-4 drug represents a significant milestone for the company and one of a number of targeted strategic goals for 2021. About ALS-4.

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The Pharma Data

MARCH 22, 2021

Basel, 22 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the decision to discontinue dosing in the Phase III GENERATION HD1 study of tominersen in manifest Huntington’s disease (HD). Dosing to stop in Phase III clinical study of tominersen following recommendation from an Independent Data Monitoring Committee (iDMC).

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Disease Clinical Trials Pharmacokinetics Treatment 52

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.

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The Pharma Data

JANUARY 17, 2021

18, 2021 (GLOBE NEWSWIRE) — Taconic Biosciences (Formerly Known As Taconic Farms, Inc.) Because the Jh mouse cannot produce ADA, there is no neutralizing or pharmacokinetic impact on the therapeutic or anaphylaxis risk. RENSSELAER, N.Y.,

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The Pharma Data

JULY 29, 2021

Today at the Alzheimer’s Association International Conference © (AAIC © 2021), Eli Lilly and Company (NYSE: LLY) presented two new exploratory analyses of data from the Phase 2 TRAILBLAZER-ALZ study. In June 2021, Lilly announced the U.S. vice president of pain and neurodegeneration, Lilly.

Disease 52

Disease Treatment Pharmacokinetics Trials 52

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

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. ?.

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The Pharma Data

NOVEMBER 4, 2020

Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., CTP-543 THRIVE-AA2 Phase 3 Trial Planned for First Half of 2021. Revenues.

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The Pharma Data

NOVEMBER 5, 2021

The data were presented at the American Society of Nephrology (ASN) 2021 Annual Meeting. Novartis moment blazoned that a Phase II study of investigational iptacopan (LNP023) – a first-in- class, oral, picky factor B asset – in cases with C3 glomerulopathy (C3G) met primary endpoints in both patient cohorts1.

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Disease Treatment Pharmacokinetics FDA 52

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. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.

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Trials Engineering Pharmacokinetics Therapies 40

The Pharma Data

DECEMBER 29, 2020

“We look forward to the continued findings from our other ongoing Phase III studies of PRX-102, with the final results from the BRIGHT study expected in the first quarter of 2021, and interim results from the BALANCE study expected in the first half of 2021.” ” Additional Details about the BRIDGE Study.

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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 Participants may balk at certain protocol requirements, such as extended visits for pharmacokinetic (PK) measurements.

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Trials Clinical Trials FDA Approval Therapies 52

New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] “Safety, tolerability, and pharmacokinetic evaluation of single- and multiple-ascending doses of a novel kappa opioid receptor antagonist LY2456302 and drug interaction with ethanol in healthy subjects” Journal of Clinical Pharmacology. nM vs. 24.0

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

The Pharma Data

JANUARY 19, 2021

20, 2021 (GLOBE NEWSWIRE) — Neuronascent Inc. , Orally delivered NNI-362 is currently in a NIA-supported and FDA-cleared Phase 1a clinical trial in healthy aged volunteers to assess safety and pharmacokinetics. CLARKSVILLE, Md., About Neuronascent, Inc.

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The Pharma Data

NOVEMBER 26, 2020

The FDA extended the PDUFA action date by three months to April 27, 2021, from January 27, 2021. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. Galactosidase-A enzyme.

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Disease Treatment Clinical Trials FDA 52

The Pharma Data

JULY 11, 2021

3 These data are being presented at the 2021 European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress in Krakow, Poland and Madrid, Spain. Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. percent and a median reduction of 98.2

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Agency IQ

JULY 26, 2024

When finalized, this will supersede recommendations from a 2021 Q&A guidance. Last finalized in 2021, the guidance “ Questions and Answers on Biosimilar Development,” includes one question and answer on postapproval manufacturing changes – question Q.I.20. in the annual report instead of via a post-approval supplement).

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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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The Pharma Data

JULY 27, 2021

. “Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. ” In June 2021, AbbVie Inc.

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