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. In addition, no evidence of nephrotoxicity was observed in the study.

Clinical Trials 52

Clinical Trials Clinical Development Pharmacokinetics Pharmaceutical Companies 52

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. X H NMR (500 MHz, DMSO-i¾) δ ppm 1.40 (d, J=6.8 Hz, 3 H), 4.98 (quin, J=7.1 Hz, 1 H), 5.09 (s, 2 H), 7.33 (d, J=7.8 88 (8): 3872–3882.

Clinical Pharmacology 62

Clinical Pharmacology Small Molecule Pharmacokinetics Pharmaceutical Companies 62

The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

Treatment 52

Treatment Pharmacokinetics Drugs Therapies 52

The Pharma Data

JANUARY 19, 2021

The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. The primary objective of the trial is to evaluate the safety and tolerability of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4. About Aptorum Group.

Small Molecule 52

Small Molecule Clinical Trials Trials Pharmacokinetics 52

DrugBank

FEBRUARY 12, 2025

This approach capitalizes on prior investments in R&D, mitigates risk by leveraging established safety and pharmacokinetic profiles, and accelerates the delivery of treatments to patients. Animal Models In vivo studies in animal models assess drug activity, pharmacokinetics, and safety in a living organism.

Cell Based Assays 52

Cell Based Assays Drugs Pharmacokinetics Disease 52

Practical Cheminformatics

JANUARY 8, 2024

While large pharmaceutical companies have data on thousands or even millions of compounds, this data is rarely shared due to intellectual property concerns. In addition to optimizing potency against a target of interest, we must design selective compounds with optimal pharmacokinetic profiles and a host of other desirable properties.

Drugs 136

Drugs Small Molecule Bioinformatics Packaging 136

The Pharma Data

AUGUST 21, 2020

It’s a coalition of globally renowned academic institutions, pharmaceutical companies and nonprofit research organizations. We are also supporting the consortium’s preclinical safety and pharmacokinetics workstreams. What are the goals of the consortium and what will Novartis contribute?

Virus 52

Virus Small Molecule Licensing Licensing 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. STOCKHOLM , Jan.

Trials 40

Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

JUNE 28, 2021

Part A evaluated the single- and multiple-dose pharmacokinetic and pharmacodynamic properties of Xarelto while Part B evaluated the comparative safety and efficacy of Xarelto versus aspirin when used for thromboprophylaxis for 12 months. by Janssen Pharmaceuticals, Inc. UNIVERSE was conducted in two parts. by Bayer and in the U.S.

FDA 52

FDA Clinical Trials Treatment Therapies 52

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations.

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

JULY 11, 2021

Based on the characteristics of lanadelumab, no pharmacokinetic interactions with co-administered medicinal products is expected. The development of ADA including neutralising antibodies against TAKHZYRO did not appear to adversely affect the pharmacokinetic (PK) and pharmacodynamics (PD) profiles or clinical response. Interactions.

Treatment 52

Treatment Pharmacokinetics Disease Production 52

The Pharma Data

DECEMBER 29, 2020

Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. The Company designed PRX-102 to potentially address the continued unmet clinical need in Fabry patients. Galactosidase-A enzyme.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

NOVEMBER 22, 2020

Molecular Partners AG is a clinical-stage biotech company developing DARPin® therapeutics, a new class of custom-built protein drugs designed to address challenges current modalities cannot. www.molecularpartners.com ; Follow the Company on Twitter at @MolecularPrtnrs. About Molecular Partners’ anti-COVID-19 program.

Trials 40

Trials Clinical Trials Licensing Licensing 40

The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

Treatment 52

Treatment Laboratories Production Disease 52

Agency IQ

FEBRUARY 23, 2024

The ideal approach, said Liu, would integrate early pharmacology data with model-based approaches to minimize patient exposure and speed drug development, in a fashion that can not just “benefit the patient, but also can help the pharmaceutical company as well.”

Science 40

Science FDA Trials Clinical Pharmacology 40

The Pharma Data

OCTOBER 27, 2020

In October 2020 , we completed a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company. NON-GAAP FINANCIAL INFORMATION.

FDA 40

FDA Production Licensing Licensing 40

DrugBank

FEBRUARY 26, 2025

In response, researchers and pharmaceutical companies are exploring novel approaches to antibiotic development. Over the past two decades, many pharmaceutical companies have deprioritized antibiotic research due to high development costs and lower profitability compared to treatments for chronic diseases.

Therapies 52

Therapies Pharmaceutical Companies Pharmacokinetics Treatment 52

Drug Target Review

MARCH 6, 2024

Given the relevance of brain metastases in cancer patients, what are the pharmacokinetic properties that enable CNS penetration of LSD1 inhibitors? To date, other LSD1 inhibitors in development have failed to achieve the combination of appropriate pharmacokinetics, required brain penetrance and a reversible mechanism of action.

Production 65

Production Pharmacokinetics Disease RNA 65

The Pharma Data

JANUARY 21, 2021

21, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients.

FDA Approval 52

FDA Approval Treatment RNA FDA 52

The Pharma Data

APRIL 27, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that that the U.S. The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). About Takeda Pharmaceutical Company Limited.

FDA 52

FDA Treatment Pharmaceutical Companies Therapies 52

The Pharma Data

OCTOBER 14, 2020

AOP Orphan – AOP Orphan Pharmaceuticals took over the Viennese pharmaceutical company Amomed and the Luxembourgish health-tech company SciPharm. Talking Medicine uses advanced AI to provide pharmaceutical companies with real-time data intelligence. Growth Programme. Dolmatics – U.K.-based

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52

The Pharma Data

MARCH 16, 2021

Efficacy, safety, pharmacokinetic, immunogenicity and biomarker evaluations were performed in the study on a defined schedule. Clinical efficacy, radiographic efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker, and pharmacogenomics evaluations were performed in the study on a defined schedule.

Treatment 52

Treatment Disease Pharmacokinetics Therapies 52

The Pharma Data

NOVEMBER 6, 2020

Secondary outcomes were: (1) the effect of aducanumab on brain amyloid plaque content as measured by [18F]-florbetapir PET, (2) the pharmacokinetics of aducanumab and (3) the immunogenicity of aducanumab. is a leading global pharmaceutical company headquartered in Japan. About Alzheimer’s Disease. About Eisai Co.,

Disease 40

Disease FDA Clinical Trials Licensing 40

The Pharma Data

SEPTEMBER 1, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. 1 Study evaluations included efficacy, safety, pharmacokinetics, and pharmacodynamics. Phase 3 non-inferiority study results showed over 92% of participants were relapse-free at 12 months.

FDA Approval 52

FDA Approval FDA Treatment Clinical Trials 52

The Pharma Data

FEBRUARY 8, 2021

In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone. About the Janssen Pharmaceutical Companies of Johnson & Johnson. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Drug Patent Watch

JANUARY 14, 2025

In the world of generic drugs, we have something even better: Physiologically Based Pharmacokinetic Modeling (PBPK). The Plot: Generic vs. Brand-Name Two major pharmaceutical companies sued over 10 generic drug manufacturers for infringing on a patent for their schizophrenia medication[4]. The bone of contention?

Drug Development 87

Drug Development Drugs FDA Production 87

The Premier Consulting Blog

DECEMBER 16, 2024

Pharmaceutical companies may, at times, find themselves at an impasse during development, facing weighty decisions about whether to slow down or hit the brakes on a development program. These decisions are complex, multi-dimensional, and can have significant impact on the future of the company.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Drug Development Pharmaceutical Companies 52

Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. Pharmaceutical companies generally charge high rates for patented drugs to recoup their huge investments into research, development, trials, and marketing.

Clinical Trials 70

Clinical Trials Virus Vaccine DNA 70