The Pharma Data

FEBRUARY 25, 2022

The study met its primary goal by demonstrating pharmacokinetic equivalence in patients who switched multiple times between treatment with the two medicines. The company anticipates submitting study results for presentation at an upcoming medical congress.

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Biosimilars FDA FDA Approval Small Molecule 52

Alta Sciences

APRIL 17, 2024

Ketamine is a dissociative anesthetic approved in 2019 by the U.S. Several small molecule GLP-1R agonists, such as oral orforglipron, are in late-stage clinical development. Food and Drug Administration (FDA) as a nasal spray called esketamine, for treatment-resistant depression.

Drug Development 52

Drug Development Treatment FDA Approval Therapies 52

New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] “LY2456302 is a novel, potent, orally-bioavailable small molecule kappa-selective antagonist with activity in animal models predictive of efficacy in mood and addictive disorders” Neuropharmacology. Lazar MA, McIntyre RS (2019).

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Drug Target Review

JULY 12, 2023

Once a new drug target is identified, a proprietary deep learning artificial intelligence (AI) platform we call Fluency can rapidly identify small molecules that selectively bind to a target of interest. Author Bio: Brett Hall Brett has been Chief Scientific Officer at Immuneering since November 2019.

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

The Pharma Data

JANUARY 10, 2021

In 2019, we introduced Vision 3×3, the company’s strategic roadmap through 2025, to build a leading biopharma company by achieving sustainable growth through multiple approaches. Independently optimized receptor bias and potency as well as pharmacokinetics to create a potentially best-in-class IL-2 product. .

Clinical Trials 40

Clinical Trials Clinical Development Small Molecule Trials 40

Agency IQ

JULY 26, 2024

in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products. Any CMC changes (e.g.,

Biosimilars 40

Biosimilars Science FDA Production 40

The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

Vaccine 52

Vaccine Therapies Trials Clinical Trials 52

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. ALS-4 is a novel small molecule adopting an anti-virulence (non-antibiotic) approach to address the growing unmet medical needs of infections caused by Staphylococcus aureus.

Small Molecule 40

Small Molecule Clinical Trials Trials Treatment 40

The Pharma Data

NOVEMBER 4, 2020

million as of December 31, 2019. million for the same period in 2019. million for the same period in 2019. per share, for the quarter ended September 30, 2019. 2019. 2019. December 31, 2019. December 31, 2019.

Pharmaceuticals 52

Pharmaceuticals Clinical Trials Trials Treatment 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. This announcement is not a prospectus within the meaning of the Regulation (EU) n°2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n°2019/980 of 14 March 2019 and n°2019/979 of 14 March 2019.

Small Molecule 52

Small Molecule Clinical Trials Trials Pharmacokinetics 52

The Pharma Data

OCTOBER 14, 2020

This funding is the second major support for Polyphor’s antibiotics program and follows a previous grant in 2019. has expanded its product portfolio to include Blueprint, a self-service, scientific visualization and analytics application for small molecule discovery. CARB-X will provide Polyphor with initial funding of up to $2.62

Clinical Trials 52

Clinical Trials Trials Pharmaceuticals Therapies 52