Alta Sciences

FEBRUARY 19, 2025

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

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New Drug Approvals

MAY 9, 2025

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 2] The FDA granted the application for elacestrant priority review and fast track designations. [2] Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1] 3] [7] PATENTS Cruskie MP, et al. 8 February 2023. 27 January 2023.

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The Pharma Data

JUNE 27, 2025

The GEMZ study is a randomized, double-blind, placebo-controlled, fixed-dose, multi-center clinical trial designed to assess the safety, efficacy, and pharmacokinetics of fenfluramine in children and adults aged 1 to 35 years diagnosed with CDD who experience uncontrolled seizures.

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New Drug Approvals

JUNE 11, 2025

4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5]

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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. Earlier this month, the U.S.

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Alta Sciences

DECEMBER 31, 2024

The issue also features a drug-drug interaction case study, in which the effects of two doses of a sponsors investigational product on the pharmacokinetics of multiple oral doses of clopidogrel, and a single dose of warfarin in healthy adult subjects were evaluated. The FDA, 2024 FDA guidance M12 Drug Interaction Studies , pg.

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DrugBank

JUNE 18, 2025

Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Before a therapy can be approved for patient use, it must undergo extensive clinical testing and strictly adhere to regulatory guidelines.

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Conversations in Drug Development Trends

JANUARY 21, 2025

Regulatory bodies such as the FDA oversee clinical trials to ensure that studies’ design, conduction, analysis, and reporting are per established guidelines and laws. Rigorous procedures to ensure that drugs are effective and safe.

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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] 2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 2] The FDA granted the approval of Crenessity to Neurocrine Biosciences, Inc. [2] Food and Drug Administration (FDA).

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New Drug Approvals

JULY 12, 2025

The safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-3248 are currently being evaluated in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. Therefore, the broad inhibition of FGFR isoforms may be effective against different types of tumors.

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New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. 32 (2): 828.

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The Premier Consulting Blog

DECEMBER 16, 2024

Pharmacokinetics and pharmacodynamics :Pharmacokinetics (PK) assess how a drug is absorbed, distributed, metabolized, and excreted by the body. Independent advice from experts.Obtain additional perspectives from consultants, advisors, or even a second opinion from the FDA. Consider using a risk-benefit analysis format.

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Quanticate

JUNE 29, 2025

The development of oncology drugs is a complex, multi-phase process, where safety, efficacy, and optimal dosing are determined progressively through clinical trials.

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PPD

APRIL 14, 2025

Food and Drug Administrations (FDA) diversity and inclusion in clinical trials mandate. For example, the SELECT trial enrollment comprised just 28% of women participants and 12% Black participants. It is worth noting that trial ran from 2018 to 2021, before the U.S.

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Drug Patent Watch

JANUARY 14, 2025

The Thyroid Association’s Concerns The American Thyroid Association (ATA) had raised concerns about the FDA’s methods for determining bioequivalence between levothyroxine products[2]. In the world of generic drugs, we have something even better: Physiologically Based Pharmacokinetic Modeling (PBPK). The results?

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Common Sense for Drug Policy Blog

OCTOBER 29, 2024

Limited Evidence for Nalfmefene "In 2021, due to the widespread availability of high-potency synthetic opioids like fentanyl, the US FDA approved two high-dose naloxone products, an 8 mg IN spray (Kloxxado) and a 5 mg IM injectable (Zimhi). In 2023, the FDA approved a 2.7 In 2023, the FDA approved a 2.7

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FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. does not use this term.

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Broad Institute

JULY 17, 2024

Together, the tools estimate how a drug may impact diverse outcomes of interest to drug developers: general cellular health, pharmacokinetics, and heart and liver function. Since the FDA released these datasets, we wondered if we could use them to predict toxicity using machine learning," said Seal.

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Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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ASPET

AUGUST 8, 2024

Lenacapavir (LEN), a long-acting injectable, is the first approved human immunodeficiency virus type 1 capsid inhibitor and one of a few FDA-approved drugs that exhibit atropisomerism.

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Drug Patent Watch

DECEMBER 10, 2024

The Importance of Scientific Expertise Generic drug development involves a deep understanding of the scientific principles underlying drug development, including pharmacology, pharmacokinetics, and bioequivalence. Scientific experts in these fields are critical in ensuring that generic drugs are developed to meet the required standards.

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ASPET

SEPTEMBER 28, 2023

These protocols were then used to determine the plasma pharmacokinetics of agmatine and the extent of distribution to the CNS. Precision and accuracy of the protocol met Food and Drug Administration (FDA) standards in surrogate matrix, as well as in corrected concentrations in appropriate matrices.

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thought leadership

DECEMBER 10, 2024

On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms.

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ASPET

JUNE 27, 2024

Secondary VAS and pharmacokinetic (PK) endpoints and adverse events were assessed. Drug Liking and all other VAS outcomes were greatest for nabilone 3mg and 6mg, which is a currently FDA-approved medication. Three doses of lenabasum (20, 60, and 120mg) were compared to placebo, and nabilone (3 and 6mg).

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Metabolite Tales Blog

APRIL 10, 2024

Table 1: Small molecule drugs approved by the FDA in 2023 with reported involvement of phase II mechanisms In vitro : In vivo differences Incubation of the SGLT2 (sodium-glucose co-transporter-2) inhibitor bexagliflozin in human liver microsomes points to metabolism through both oxidation and glucuronidation to 6 main metabolites.

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The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. The therapeutic dose of pirfenidone approved by the US Food and Drug Administration (FDA) for the treatment of IPF is 801 mg three times a day.

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The Premier Consulting Blog

APRIL 15, 2024

It is critical that the nonclinical program outlined in the PIND briefing document is presented in a manner that allows FDA to provide relevant input on the required IND-enabling studies. For example, if the nonclinical data presented in the PIND briefing document lacks information on the potential toxicity profile of the drug (e.g.,

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. are major metabolites according the FDA Metabolites in Safety Testing guidelines). 2] Iversen et al.,

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The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

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Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. 16 This concludes our exploration of metabolism of last year’s FDA approved small molecule drugs.

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Conversations in Drug Development Trends

DECEMBER 20, 2023

His presentation covered various aspects of oncology clinical programs, focusing on study design trends, with reference to both the recently implemented FDA Project Optimus guidance and studies we have seen from sponsors.

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The Pharma Data

JUNE 7, 2022

New Indication for Amgen’s Fifth FDA-approved Biosimilar. The randomized, double-blind, comparative clinical study compared the efficacy, safety, pharmacokinetics and immunogenicity of RIABNI versus rituximab reference product (RP) in patients with moderate to severe RA. Now Approved to Treat All Available Rituxan ® Indications.

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Agency IQ

AUGUST 11, 2023

FDA looking to beef up its remote assessments with artificial intelligence According to a new FDA contract notice, the agency is interested in procuring a new artificial intelligence-based Optical Character Recognition system to extract data from PDFs obtained during remote regulatory assessments. What does the FDA want to do, anyways?

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Quanticate

OCTOBER 27, 2024

Successful completion of each phase and approval by the appropriate regulatory authority or authorities (the European Medicines Agency [EMA] in the European Union, Food and Drug Administration [FDA] in the United States, Health Canada in Canada, or the Ministry of Health, Labour and Welfare in Japan) is required for progression to the next phase.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. For more on FDORA’s other provisions, see HPM’s complete summary here ). 21 U.S.C. § 355(i)(1)(A).

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Agency IQ

AUGUST 16, 2024

The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways On August 9, Lykos Therapeutics received a Complete Response Letter (CRL) from FDA stating the agency will not currently approve its application for midomafetamine (MDMA) to treat post-traumatic stress disorder.

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The Pharma Data

JUNE 28, 2021

Food and Drug Administration (FDA) for the use of the oral anticoagulant Xarelto (rivaroxaban) in pediatric patients. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure. for use in appropriate pediatric patients.

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