Alta Sciences

JUNE 26, 2025

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Pharmacokinetics Testimonials Biosimilars Drug Development 40

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.

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Pharmacokinetics Therapies Treatment Trials 40

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.

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Packaging Pharmacokinetics Therapies Marketing 52

Alta Sciences

JULY 3, 2025

All Rights Reserved. Cookie Policy | Privacy Policy Have a question? × Id be happy to help. No, thanks. Captcha is required.

Marketing 40

Marketing Pharmacokinetics Testimonials Biosimilars 40

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.

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Trials Treatment Pharmacokinetics Clinical Trials 40

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.

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Drugs Pharmacokinetics FDA Production 52

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.

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FDA Approval FDA Treatment Therapies 40

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).

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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.

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Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

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.

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FDA Clinical Trials Treatment Trials 62

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 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

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.

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Treatment Clinical Trials Therapies Molecular Biology 59

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 40

Science FDA Production Drugs 40

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 40

FDA Trials Therapies Regulations 40

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 40

Clinical Trials Clinical Development Small Molecule Trials 40

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 40

Biosimilars Science FDA Production 40

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.

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Pharmacokinetics Vaccine Disease Drugs 130

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.

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Small Molecule Pharmacokinetics Treatment Compliance 52

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 52

Immune Response Pharmacokinetics Clinical Trials Therapies 52

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.

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FDA Pharmacokinetics Clinical Pharmacology Government 40

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.

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Clinical Trials Trials Clinical Pharmacology Drug Development 52

Agency IQ

FEBRUARY 15, 2024

Priority A List.

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FDA Science Biosimilars Clinical Trials 40

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)).

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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.

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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.

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Vaccine Therapies Trials Clinical Trials 52

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).

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Pharmacokinetics FDA FDA Approval Treatment 62

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 52

Clinical Development Small Molecule Drugs FDA Approval 52

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.

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Treatment Drugs Clinical Trials Trials 59

Metabolite Tales Blog

FEBRUARY 20, 2025

Three of these are circulating active metabolites which have similar pharmacological activity to the parent drug, and may contribute to the overall efficacy. Excretion through faeces The drug is primarily excreted through faeces and was shown to be stable in a faecal microbial environment under anaerobic conditions. Engelen, A.,

Pharmacokinetics 52

Pharmacokinetics Treatment Drugs 52

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

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FDA FDA Approval Production Treatment 62

New Drug Approvals

MAY 11, 2025

3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] 3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9] Retrieved 17 April 2025.

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FDA FDA Approval Disease Production 57

New Drug Approvals

APRIL 21, 2025

1] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 3] The US Food and Drug Administration (FDA) granted the application for revumenib priority review , breakthrough therapy , and orphan drug designations. [3] Food and Drug Administration (FDA) (Press release). 17 (1): 113.

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FDA Approval FDA Clinical Trials Pharmaceuticals 67

New Drug Approvals

MAY 27, 2025

PATENT Journal of the American College of Cardiology (2018), 72(5), 489-497 American Heart Journal (2022), 253, 20-29 Expert Opinion on Investigational Drugs (2020), 29(1), 1-4 EP4119137 WO2016165014 WO2023108146 EP-2170050-B1 US-9737503-B2 US-4968717-A EP-0231003-A2 [1]. 2025 Apr 1:10915818251327963. Stambler BS, et al. Int J Toxicol.

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Pharmaceuticals Small Molecule Pharmacokinetics Treatment 67

New Drug Approvals

MAY 10, 2025

3] [4] The drug can be administered with or without food. [5] M+1] References ^ “Monthly Report: New Drug Approval in China, May 2024” ^ “” PhIRDA. Retrieved 26 April 2025. ^ 2] In the United States, it is in Phase III trials as of 2023. [3] 0460] 1 H NMR(400MHz,MeOD)7.83(m,2H),7.42(m,3H),3.31(dt,4H),2.86(m,1H),2.55(d,2H),2.48(ddd,1H),2.32(dd,1H),2.15(m,1H),2.04(m,1H),1.77(m,1H),1.62(m,4H),1.45(m,1H),1.28(dt,1H)

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International Production Pharmacokinetics Treatment 62

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.

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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.

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FDA Approval FDA Production Treatment 62

Codon

FEBRUARY 23, 2025

By Kamal Nahas Scientists had no antiretroviral drugs when the AIDS crisis began in 1981. In January 2025, the incoming Trump administration issued a 90-day freeze on PEPFAR while it conducts a “programmatic efficiencies” review. This article concludes Issue 05. We’ll see you in a few weeks for Issue 06!

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