FDA Approval, Pharmacokinetics and Regulations

FDA Approves First COVID-19 Treatment for Young Children

The Pharma Data

APRIL 26, 2022

Learn more about FDA-approved and authorized COVID-19 vaccines. Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. The only approved dosage form is Veklury for injection.

FDA Approval

FDA Approval FDA Treatment Vaccine

Metabolism of 2022 FDA approved small molecule drugs PART 2

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. Dermavant’s tapinarof is one such friend. 8 This is not the only point of interest.

Small Molecule

Small Molecule FDA Approval FDA Drugs

Advanced 3D cell-based technologies

Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. To this end, the FDA’s newly created iSTAND initiative drives the path toward regulatory approval for devices like organ-on-chips.

Animal Testing

Animal Testing Clinical Trials Pharmaceutical Companies FDA

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] “FDA Approves New Drug for Ulcerative Colitis” Medscape.

FDA

FDA FDA Approval International Pharmacokinetics

Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

The Pharma Data

APRIL 27, 2021

The Phase 1/2 trial aims to evaluate the safety, pharmacokinetics and anti-tumor activity of oral mobocertinib in patients with non-small cell lung cancer (NSCLC). Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. About the Phase 1/2 Trial.

FDA

FDA Treatment Pharmaceutical Companies Therapies

Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis

The Pharma Data

MAY 17, 2023

BTK, also known as tyrosine-protein kinase BTK, is an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS.

FDA Approval

FDA Approval Disease Clinical Trials Trials

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

The Pharma Data

OCTOBER 25, 2020

“We are pleased to continue pursuing additional neuroscience opportunities with BXCL501, targeting agitation associated with delirium, a fifth potential indication for this candidate and a condition for which there is no FDA-approved treatment,” commented Vimal Mehta, Chief Executive Officer of BTI.

Treatment

Treatment Trials FDA Hospitals

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

The Pharma Data

DECEMBER 29, 2020

Patients had the option to receive PRX-102 infusions in a home care setting based on infusion tolerability and country regulation. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. About Fabry Disease. Galactosidase-A enzyme.

Clinical Trials

Clinical Trials Disease Treatment Trials

Advances in the Battle Against Autoimmune Disease

The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Daratumumab already is approved for the treatment of multiple myeloma. The secondary outcome involves pharmacokinetic endpoints. The human monoclonal antibody targets specific immune plasma cells. Bioelectronic Platform.

Disease

Disease Clinical Trials Small Molecule Trials

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

DECEMBER 1, 2023

Over the course of the PHE—which spanned more than three years—the FDA used its expanded authority extensively to issue new direct-to-final guidance documents, creating over 80 in total. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

FDA

FDA Clinical Trials Vaccine Trials

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals.

DNA

DNA RNA Engineering Licensing

Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Agency IQ

SEPTEMBER 22, 2023

In 1972, when regulatory authority for biologic products was transferred from the National Institutes of Health (NIH) to the FDA, the agency extended the two-study framework to biologic regulation as well. Analysis Sponsors should exercise caution when applying this guidance to their development programs.

FDA

FDA Science Trials Clinical Trials

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Therapies

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

The Pharma Data

JANUARY 21, 2021

Hepatic Impairment: EDURANT ® should be used with caution in patients with severe hepatic impairment (Child-Pugh Class C) as pharmacokinetics of EDURANT ® have not been evaluated in these patients. . Please see full Prescribing Information for more details. Use in Specific Populations.

FDA Approval

FDA Approval Treatment RNA FDA

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

Science

Science FDA Clinical Trials Clinical Pharmacology

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

FDA Law Blog: Biosimilars

MAY 21, 2024

The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration. 802(16)) and regulated by 21 C.F.R. d)(23) and marijuana extracts (drug code 7350) regulated by 21 C.F.R. Basis at 18; NPRM at 44,605. Basis at 24. Basis at 63-64.

Regulations

Regulations FDA Treatment Drugs

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

The Pharma Data

APRIL 8, 2021

Food and Drug Administration (FDA) approved EVRYSDI for the treatment of SMA in adults and children 2 months of age and older. EVRYSDI was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by FDA and EMA in 2017 and 2019, respectively. Europe and Japan.

Clinical Trials

Clinical Trials Trials Disease Therapies

Medicare Coverage Analysis Worksheet

Advarra

DECEMBER 14, 2022

FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. Other devices, such as premarket approvals (PMAs) and 510ks, are not considered as qualifying clinical trials and do not require research modifiers to be eligible for coverage. drugs and biologicals.

Clinical Trials

Clinical Trials Trials Compliance Pharmacokinetics

Drug Discovery Digest

FDA Approves First COVID-19 Treatment for Young Children

Metabolism of 2022 FDA approved small molecule drugs PART 2

Trending Sources

Advanced 3D cell-based technologies

Etrasimod

Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

Roche’s BTK inhibitor fenebrutinib significantly reduced brain lesions in people with relapsing forms of multiple sclerosis

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

Advances in the Battle Against Autoimmune Disease

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Codon Digest: Injected Gene Editors

Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Janssen Presents Results from Phase 3 ACIS

Janssen Announces U.S. FDA Approval of CABENUVA (rilpivirine and cabotegravir), the First Long-Acting Regimen for the Treatment of HIV

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Buckle Up: DOJ Initiates Rulemaking to Reschedule Marijuana

2021 AAN highlight impact and breadth of expanding neuroscience portfolio

Medicare Coverage Analysis Worksheet

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