The Premier Consulting Blog

AUGUST 8, 2024

For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g., October 2019. [iv] patients with renal, hepatic, or cardiovascular concerns). July 28, 2023. iii] US Food and Drug Administration. Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products.

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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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The Pharma Data

JULY 2, 2023

To this end, the team carefully evaluated hits from a screen of around ten thousand small molecule compounds and identified icFSP1 as a new in vivo effective drug. Although FSP1 has been considered as an attractive drug target for cancer therapy, in vivo efficacious FSP1 inhibitors have been lacking.

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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.

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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.

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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 Drugs 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).

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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

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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. .

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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.

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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.,

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