PPD

OCTOBER 12, 2023

Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

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Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 21] In August 2017, it was announced that Cerecor had sold its rights to aticaprant to Janssen Pharmaceuticals. [22] 22] [21] Janssen was also experimenting with esketamine for the treatment of depression as of 2017. [21] Dhir A (January 2017).

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

New Drug Approvals

OCTOBER 24, 2023

1 Therefore, S1P receptor modulators like etrasimod were investigated in treating immune-mediated diseases like ulcerative colitis where a high level of inflammatory T cells is present in the gastrointestinal tract, thus causing diffuse mucosal inflammation. Peyrin-Biroulet L, Christopher R, Behan D, Lassen C (May 2017). July 2022).

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FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

DECEMBER 20, 2020

Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

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The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. Inozyme Pharma was founded in 2017 by Joseph Schlessinger, Ph.D., . BOSTON, Jan.

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Clinical Trials Trials Treatment FDA 52

Alta Sciences

APRIL 17, 2024

Gene Therapy Gene therapy is currently considered for diseases, often rare, that have no other cures. We have conducted over 130 in-life studies in the last five years (over 95% conducted in NHPs), including IND-enabling studies for rare diseases and CRISPR gene editing therapeutics in NHPs.

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Drug Development Treatment FDA Approval Drugs 52

The Pharma Data

APRIL 8, 2021

OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS). Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs). Following U.S.

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Clinical Trials Trials Disease Therapies 52

Metabolite Tales Blog

JANUARY 23, 2024

The drug is therefore contraindicated in cases where severe renal impairment or end‐stage renal disease has been confirmed, as well as in combination with CYP1A2 inhibitors [7]. Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. link] [11] Zheng et al.,

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Small Molecule FDA Approval FDA Pharmacokinetics 52

Metabolite Tales Blog

DECEMBER 13, 2023

Pharma Res Per 1 (1), 2013, e00002; [link] [4] Discovery of an oral, rule-of-5 compliant, IL-17A protein-protein interaction modulator (PPIm) for the treatment of psoriasis and other inflammatory diseases. 8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality.

Small Molecule 59

Small Molecule Metabolic Stability Treatment Pharmacokinetics 59

Agency IQ

SEPTEMBER 15, 2023

In 2017, the FDA expanded the restrictions , which include behind-the-counter sale requiring photo identification with a per-month individual purchase quota, to products containing ephedrine and phenylpropanolamine — effectively narrowing the decongestant drugs approved for over-the-counter sale.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

OCTOBER 27, 2020

Tyvaso in pulmonary hypertension due to interstitial lung disease (PH-ILD). Tyvaso also showed benefits across several key subgroups, including etiology of PH-ILD, disease severity, age, gender, baseline hemodynamics, and dose. Medtronic), the premarket approval application (PMA) for the ISR was approved by the FDA in December 2017.

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FDA Production Licensing Licensing 40

Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. And I do think it’s really important to go as high up as we can safely, because there are issues that have already been mentioned – inter-tumor heterogeneity, issues of tumor penetration and [pharmacokinetics] PK.”

Science 40

Science FDA Trials Clinical Pharmacology 40

The Pharma Data

NOVEMBER 6, 2020

The Advisory Committee also voted 0 yes, 7 no and 4 uncertain on the question, “Does Study 103 (PRIME) provide supportive evidence of the effectiveness of aducanumab for the treatment of Alzheimer’s disease?”, Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer’s disease.

Disease 40

Disease FDA Clinical Trials Licensing 40

New Drug Approvals

SEPTEMBER 29, 2024

gingivalis has been called a risk factor for Alzheimer’s disease ( Kanagasingam et al., 2017 ; Ilievski et al., gingivalis is associated with cardiovascular disease. In aged dogs with periodontal disease, ninety days of COR388 reduced oral bacterial load and gum pathology ( Arastu-Kapur et al., 2018 ; Ding et al.,

Small Molecule 62

Small Molecule DNA Disease Trials 62

The Pharma Data

MARCH 9, 2022

Sanofi and Swedish Orphan Biovitrum AB (publ) (Sobi ® ) (STO:SOBI) today announced positive topline results from the pivotal XTEND-1 Phase 3 study evaluating the safety, efficacy and pharmacokinetics of efanesoctocog alfa (BIVV001) in previously treated patients ?12 12 years of age with severe hemophilia A.

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Treatment Pharmacokinetics Therapies FDA 52

The Pharma Data

MARCH 16, 2021

PsA can be a chronically painful and debilitating disease, and many PsA patients are still searching for enduring relief of their symptoms,” said Philip J. Vice President, Rheumatology Disease Area Leader, Janssen Research & Development, LLC. 1,2 TREMFYA is the first and only IL-23 inhibitor therapy approved in the U.S.

Treatment 52

Treatment Disease Pharmacokinetics Therapies 52

The Pharma Data

JANUARY 3, 2021

Preclinical data from our laboratory have shown that the nasal administration of anti-CD3 stimulates Tregs that can suppress inflammation and ameliorate inflammatory diseases. The pharmacokinetics of nasally administered Foralumab will also be evaluated. . NEW YORK and LONDON, Jan. About Foralumab.

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Clinical Trials Science Treatment Trials 40

The Pharma Data

MARCH 16, 2021

SUNFISH Part 2 study population includes broad range of ages and disease severities, representing a real-world spectrum of people living with Type 2 or 3 SMA. Based on the natural history of the disease, people with Types 2 and 3 SMA who remain untreated decline in motor function over time. The study met its primary endpoint.

Pharmacokinetics 52

Pharmacokinetics Treatment Clinical Trials Disease 52

Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. A third workshop was held in 2017 and focused on combination products, use of biomarkers and novel endpoints, and modeling and simulation approaches.

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FDA Science Clinical Trials Trials 40

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Clinical Trials 40

The Pharma Data

SEPTEMBER 15, 2020

Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology. Rare Disease. Pipeline contributes to the Company’s expectation of at least 6% revenue CAGR over the next five years – and delivery of longer-term topline growth beyond that period. A Phase 3 trial is ongoing.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

Drug Target Review

OCTOBER 4, 2023

Antibody-drug conjugates (ADCs) have been a groundbreaking approach to cancer treatment with their ability to deliver cytotoxic drugs directly to diseased cells while sparing healthy tissues. These include inflammation, cancer, infectious disease, and addiction. 56 , 733–737 (2017). 66 , 10715–10733 (2023). Levengood MR, et al.

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Small Molecule Drugs Immune Response Targeted Protein Degradation 127

Agency IQ

AUGUST 16, 2024

Returning to long-term considerations, diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. On Friday, the FDA issued its final guidance on optimizing the dosage of human prescription drugs and biological products in treating oncologic diseases. What’s new?

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Production FDA Science Clinical Trials 40

The Pharma Data

FEBRUARY 25, 2021

FIREFISH Part 1 data show treatment with Evrysdi at 12 months helped 90% of these infants survive without permanent ventilation and 33% sit without support, a key motor milestone not normally seen in the natural course of the disease. fold from baseline in the high-dose cohort at 12 months. mg/kg for Part 2.

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FDA Approval Pharmacokinetics Treatment Disease 52

The Pharma Data

SEPTEMBER 27, 2020

Of the 17 infants treated with the therapeutic dose, two experienced fatal complications of their disease at 8 and 13 months of treatment and one infant was withdrawn from the study and sadly died 3.5 About SMA SMA is a severe, progressive neuromuscular disease that can be fatal. At the time of the analysis, the youngest infant was 28.4

FDA Approval 52

FDA Approval Pharmacokinetics Treatment Clinical Trials 52

The Pharma Data

FEBRUARY 8, 2021

ACIS is a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA ® and ZYTIGA ® plus prednisone compared to placebo and ZYTIGA ® plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT. The primary endpoint of the study was rPFS. .‡

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

The Pharma Data

OCTOBER 6, 2021

About AZD7442 AZD7442 is a combination of two LAABs-tixagevimab (AZD8895) and cilgavimab (AZD1061)- decided from B- cells bestowed by convalescent cases after SARS-CoV-2 disease. 2017; 61 (3) e01714-16. Chats regarding budget agreements for AZD7442 are ongoing with the US Government as well as other governments around the world.

Pharmacokinetics 52

Pharmacokinetics Trials Government Vaccine 52

The Pharma Data

AUGUST 22, 2021

We are very encouraged by these efficacy and safety data in high-risk people, showing our long-acting antibody combination has the potential to protect from symptomatic and severe disease, alongside vaccines. 2017; 61(3): e01714-16. Approximately 73% were White/Caucasian, 17% Black/African American, and 3% Asian. About AstraZeneca.

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Trials Vaccine Virus Pharmacokinetics 52