2025, Clinical Pharmacology and Drugs

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Alta Sciences

FEBRUARY 19, 2025

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development pmjackson Wed, 02/19/2025 - 21:30 The unique physicochemical properties of oligonucleotides require the use of specialized bioanalytical approaches, with key considerations including selectivity and specificity, sensitivity, stability, and matrix effects.

Drug Development

Drug Development Clinical Pharmacology Immune Response Drugs

Altasciences’ Ophthalmic Expertise: A Conversation with Dr. Simone Iwabe, DVM, PhD, DACVO and Randy Wheeland, BS

Alta Sciences

APRIL 10, 2025

Simone Iwabe, DVM, PhD, DACVO and Randy Wheeland, BS pmjackson Thu, 04/10/2025 - 19:59 As a leading partner in ocular therapy, Altasciences has been at the forefront of ophthalmic drug development for over 30 years, having completed more than 100 ocular studies to assess the safety of new drug products intended for human use.

Clinical Pharmacology

Clinical Pharmacology Drug Development Drugs Research

Landiolol

New Drug Approvals

APRIL 19, 2025

Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Contrary to landiolol, exposure to other -blockers such as esmolol amplifies the re-expression of -receptors which explains the drug tolerance effect seen during long-term esmolol infusion. Jump up to: a b “Novel Drug Approvals for 2024” U.S.

FDA

FDA Clinical Trials Treatment Trials

ATICAPRANT

New Drug Approvals

SEPTEMBER 13, 2024

2] [3] [4] A regulatory application for approval of the medication is expected to be submitted by 2025. [2] 2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Pharmacology Pharmacodynamics Aticaprant is a potent , selective , short-acting (i.e., 2] Aticaprant is taken by mouth. [1]

Treatment

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Read our analysis of that rule here and here. ]

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

FDA

FDA Science Regulations Production

How Improving Diversity Can Benefit Clinical Trials

Alta Sciences

JULY 31, 2024

How Improving Diversity Can Benefit Clinical Trials pmjackson Wed, 07/31/2024 - 19:19 In July 2024, the U.S. Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025.

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Drug Development

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

JULY 28, 2023

First, an audit of communications and meeting management under the Prescription Drug User Fee Act (PDUFA) Quick background: As AgencyIQ has previously discussed, the FDA collects user fees as part of an essential bargain between regulators and industry. This week, FDA posted several new special notice contract opportunities on SAM.

FDA

FDA Pharmacokinetics Clinical Pharmacology Government

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

Priority A List.

FDA

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

The documents describe all the guidance documents that are under development and that may be published in a given year. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

FDA

FDA Science Clinical Trials Regulations

Altasciences Receives 2025 CDMO Leadership Award in Small Molecule Dosage Form Category

Alta Sciences

MARCH 27, 2025

Altasciences Receives 2025 CDMO Leadership Award in Small Molecule Dosage Form Category pmjackson Thu, 03/27/2025 - 19:42 Laval, Qubec, March 27, 2025 Altasciences , a nine-time CRO Leadership Award winner, is proud to announce they have been awarded a 2025 CDMO Leadership Award in the Small Molecule Dosage FormNorth America category.

Small Molecule

Small Molecule Clinical Pharmacology Drug Development Pharmaceuticals

Beyond ELISA: the future of biomarker validation

Drug Target Review

NOVEMBER 27, 2024

Introduction Biomarkers are becoming increasingly essential in drug development and clinical practice, driving the need for more precise validation methods. 1 The journey to qualifying biomarkers for clinical and regulatory use is fraught with challenges, leading to a remarkably low success rate. For example, only about 0.1

Drug Development

Drug Development Regulations Laboratories FDA

Iomeprol

New Drug Approvals

APRIL 18, 2025

. ^ Jump up to: a b “Novel Drug Approvals for 2024” U.S. Food and Drug Administration (FDA). New Drug Therapy Approvals 2024 (PDF). Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025. 1 October 2024.

FDA

FDA Production FDA Approval Clinical Pharmacology

Acoramidis

New Drug Approvals

APRIL 21, 2025

6] Acoramidis was approved for medical use in the United States in November 2024, [6] [7] [8] [9] and in the European Union in February 2025. [2] 2] Acoramidis was authorized for medical use in the European Union in February 2025. [2] 11 February 2025. Retrieved 16 February 2025. Food and Drug Administration.

FDA Approval

FDA Approval FDA Production Treatment

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

A closer look at the seven new proposed regulations Stage of Rulemaking Title Estimated Publication Synopsis Proposed Rule Amendments to the Current Good Manufacturing Practice Regulations for Drug Products February 2025 FDA is proposing to amend the Current Good Manufacturing Practice Regulations for Drug Products.

Regulations

Regulations FDA Science Production

Drug Discovery Digest

Regulatory Guidance for Oligonucleotide Bioanalysis in Drug Development

Altasciences’ Ophthalmic Expertise: A Conversation with Dr. Simone Iwabe, DVM, PhD, DACVO and Randy Wheeland, BS

Trending Sources

Landiolol

ATICAPRANT

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

How Improving Diversity Can Benefit Clinical Trials

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Altasciences Receives 2025 CDMO Leadership Award in Small Molecule Dosage Form Category

Beyond ELISA: the future of biomarker validation

Iomeprol

Acoramidis

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

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