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 Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. This scarcity disrupts research timelines and limits the ability to replicate results across studies.

Drug Research

The Pharma Data

JUNE 22, 2025

The study marks a significant step forward in the treatment landscape for haemophilia A, demonstrating not only clinical safety and pharmacokinetic stability, but also strong patient preference for the Mim8 pen-injector delivery system. The clinical development of Mim8 comes at a time of significant innovation in haemophilia care.

Pharmacokinetics

The Pharma Data

JUNE 23, 2025

In tandem with the Phase 2 results, Amgen also shared detailed data from its Phase 1 Pharmacokinetics Low Dose Initiation (PK-LDI) study. Crucially, weight loss in the MariTide-treated groups had not plateaued at the 52-week mark , indicating the drug’s potential to drive continued weight reduction beyond one year.

Trials

The Pharma Data

JUNE 25, 2025

These studies demonstrated that the BRUKINSA tablet formulation is bioequivalent to the existing capsule form, confirming that patients switching between formulations can expect comparable pharmacokinetics and clinical outcomes. Alignment with U.S. Earlier this month, the U.S.

Packaging

The Pharma Data

JUNE 11, 2025

Food and Drug Administration (FDA). Conducted in healthy adult volunteers, these studies were designed to evaluate the pharmacokinetics and establish bioequivalence between the new tablet and the original capsule form. a global oncology-focused biopharmaceutical company, has received a significant regulatory milestone from the U.S.

FDA Approval

New Drug Approvals

JULY 19, 2025

CZA rapidly converts into the active drug CZD in vivo. In a pharmacokinetic (PK) rat model, the exposure of active drug CZD after IV administration of the prodrug CZA was similar to or higher than that from the IV administration of CZD. Drugs 2021, 81, 1587− 1591. (34) “Contezolid: First Approval” Drugs.

Clinical Trials

New Drug Approvals

JULY 2, 2025

Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] Orforglipron ( LY-3502970 ) is an oral, non-peptide, small-molecule GLP-1 receptor agonist developed as a weight loss drug by Eli Lilly and Company. [1] April 17, 2025.

Small Molecule

New Drug Approvals

JULY 25, 2025

The distinction between it and traditional corticosteroid drugs lies in its capacity to specifically activate particular signaling pathways of corticosteroids. In individuals diagnosed with DMD, the primary mechanism through which corticosteroid drugs exhibit their effectiveness is by exerting anti-inflammatory effects. Nagaraju, J.M.

FDA

Covalent Modifiers

AUGUST 9, 2025

2025 [link] Resulting in several million deaths globally, the COVID-19 pandemic has highlighted the criticality of antiviral drugs during a viral pandemic. Compound 18 demonstrated dose-dependent efficacy in a mouse-adapted SARS-CoV-2 infection model, with favorable pharmacokinetic profiles in mice, rats, dogs, and monkeys.

Pharmacokinetics

New Drug Approvals

AUGUST 7, 2025

5] Repotrectinib was approved for medical use in the United States in November 2023, [5] [6] and in the European Union in January 2025. [3] These mutations restrict the ability of drugs to bind to their targets, ultimately resulting in the advancement of tumors. Retrieved 23 May 2025. 14 January 2025. in DMF (4.0

FDA

New Drug Approvals

APRIL 18, 2025

2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 1] [2] Adverse effects The US Food and Drug Administration prescription label for crinecerfont has a warning for acute adrenal insufficiency or adrenal crisis. [2] Retrieved 25 January 2025. Food and Drug Administration (FDA).

FDA

Covalent Modifiers

JULY 8, 2025

2025 [link] The coronavirus disease 2019 (COVID-19) pandemic crisis has been mitigated by worldwide efforts to develop vaccines and therapeutic drugs. Subsequent optimization efforts yielded S-892216, which combined a favorable pharmacokinetic profile and high off-target selectivity.

Pharmacokinetics

Alta Sciences

APRIL 24, 2025

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study pmjackson Thu, 04/24/2025 - 21:43 For emerging therapies with pronounced pharmacological effects, thoughtful study design is critical to ensuring reliable and interpretable data. This blog was originally published in April 2025.

Small Molecule

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

Alta Sciences

JUNE 26, 2025

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Pharmacokinetics

Alta Sciences

JUNE 26, 2025

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Pharmacokinetics

Alta Sciences

JULY 3, 2025

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Marketing

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.

Drugs

PPD

OCTOBER 12, 2023

There are over 2,000 CGTs currently being evaluated in clinical trials, with more than 200 in Phase III and 10-20 per year estimated to come to market by 2025. Click to enlarge At several steps during CGT development and testing, sensitive, accurate and precise quantitation of CGT drug vectors is required.

Laboratories

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] 10] However, a more recent study assessing neuroendocrine effects of the drug in normal volunteers and subjects with a history of cocaine dependence reported observations consistent with modest MOR antagonism at the 10 mg dose. [11]

Treatment

Drug Target Review

JULY 1, 2024

Can you explain the mechanism of action of SRP-001 and how it differs from traditional analgesics like acetaminophen (ApAP) and non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute, chronic and neuropathic pain? We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment

Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. What does that mean: a “new drug”?

Science

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. First, nearly all psychedelics are Schedule I drugs under the Controlled Substances Act (CSA).

FDA

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. The company submitted its Biologic License Application to the FDA which has set a Prescription Drug User Fee Act (PDUFA) date for June 25, 2021.

Clinical Trials

Agency IQ

JULY 26, 2024

In its Fiscal Year 2025 budget proposal , the FDA requested that Congress “eliminate the statutory distinction between the approval standard for biosimilar and interchangeable biosimilar products” and “deem all approved biosimilars to be interchangeable with their respective reference products.” Any CMC changes (e.g.,

Biosimilars

Alta Sciences

APRIL 11, 2025

Best Practices for Preclinical Dose Range Finding Studies pmjackson Fri, 04/11/2025 - 20:05 Dose range finding (DRF) studies are the foundation of preclinical drug development, providing crucial information on safety data to assist in the dose level selection before advancing into toxicology studies.

Immune Response

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

Agency IQ

FEBRUARY 15, 2024

Priority A List.

FDA

Alta Sciences

JULY 31, 2024

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. Genetic variations observed in different racial groups' genomic profiles can also be a contributor to adverse therapeutic responses to drugs.

Clinical Trials

FDA Law Blog: Drug Discovery

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)).

FDA

Agency IQ

JUNE 28, 2024

The overhauled guidance, which was entirely re-written after FDA obtained new authority from Congress in 2022, offers granular recommendations on how sponsors of both drug and device programs should interpret compliance with the new legal requirements, and also answers questions about how FDA intends to waive certain requirements.

FDA

The Pharma Data

SEPTEMBER 15, 2020

27 key programs highlighted, including assets that could potentially contribute revenue by 2025 and others in the 2026-2028 time frame. Major revenue contributions through 2025 anticipated from Oncology, Vaccines, Rare Disease and Inflammation and Immunology.

Vaccine

New Drug Approvals

MAY 14, 2025

7] This pharmacokinetic property has supported its investigation for the treatment of deep-seated Candida infections, including osteomyelitis. [8] It is an echinocandin, a quaternary ammonium ion, an antibiotic antifungal drug, an azamacrocycle, a homodetic cyclic peptide and an aromatic ether. Albanell-Fernndez M (January 2025).

Pharmacokinetics

Drug Target Review

APRIL 21, 2025

LB Pharmaceuticals is making significant strides in the field of drug discovery, particularly in the development of therapies for neuropsychiatric diseases such as schizophrenia. Through their work, LB Pharmaceuticals showcases how early-stage therapeutics in drug discovery can lead to solutions for longstanding medical challenges.

Treatment

Drug Target Review

APRIL 25, 2025

Recent advancements in human-relevant 3D models have paved the way for early predictive insights into pre-clinical drug discovery. 4 Liver CIVMs offer several benefits over conventional in vitro systems including prolonged functional activity, enhanced expression of various drug-metabolising enzymes and transporters.

Clinical Development

New Drug Approvals

APRIL 5, 2025

9] It belongs to the family of drugs called alkylating agents. [9] 7] Treosulfan was authorized for medical use in the European Union in June 2019, [9] and approved for medical use in the United States in January 2025. [7] 9] It belongs to the family of drugs called alkylating agents. [9] TREOSULFAN C 6 H 14 O 8 S 2 MW 278.29

FDA