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. Oxidation of adagrasib occurs on the methylpyrrolidine group 4. Gut 1996; 38: 439-446.

Small Molecule

FDA Law Blog: Drug Discovery

DECEMBER 7, 2022

Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

Therapies

The Pharma Data

MARCH 11, 2021

Eli Lilly and Company (NYSE: LLY) today announced that data from programs across its oncology portfolio and pipeline will be presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, to be held virtually April 10-15, 2021. Pipeline Highlights. Retevmo (selpercatinib). Abstract Number: CT011.

Research

FDA Law Blog: Biosimilars

NOVEMBER 5, 2023

This prestigious four-day conference promises to deliver a wealth of cutting-edge insights, featuring presentations by eminent scientists and clinicians, all unified under the thought-provoking theme, “Towards Better Speech Perception and Beyond.” The comprehensive agenda for the symposium can be accessed in its entirety here.

Science

The Pharma Data

SEPTEMBER 2, 2020

New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Clinical Trials

FDA Law Blog: Biosimilars

MARCH 3, 2024

The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. The legislation may be revised, and the below is not an exhaustive list of our questions and concerns, but at present we have several observations and questions about how the Act may be implemented and potential consequences.

Government

Pharmaceutical Development Group

JANUARY 7, 2022

Effective and consistent use and application of Data Standards can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services, 505(b) NDA, IND Consulting , NDA Consulting, BLA Consulting , and effective FDA Pre-Submission collectively resulting in FDA Approval. Spanogle, Ph.D.

FDA

Pharmaceutical Development Group

DECEMBER 19, 2021

Effective use of Real World Data (RWD) and Real World Evidence (RWE) can reduce costs of Pharmaceutical Drug and Biologic Products and Process Development, Drug Development Services , expedite a FDA Pre-Submission Review, and lead to FDA Approval. Author Information William E. Spanogle, Ph.D.

FDA Approval

The Pharma Data

OCTOBER 15, 2020

The findings were presented at TCT Connect , the 32nd annual scientific symposium of the Cardiovascular Research Foundation. In the first study, presented by Hemindermeet Singh, MD, of Ascension St. This press release features multimedia. View the full release here: [link]. Figure 1 (Graphic: Business Wire). The Impella 2.5,

Hospitals

The Pharma Data

JULY 21, 2021

– Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new data from its leading portfolio of eye care medicines at the 2021 ASCRS (American Society for Cataract and Refractive Surgery) Annual Meeting being held July 23-27 in Las Vegas, NV. Details about Allergan’s presentations are as follows: .

Treatment

FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.

Compliance

Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. The result was the addition of Section 503A to the FD&C Act.

FDA

The Premier Consulting Blog

DECEMBER 28, 2023

Under section §812.10, a sponsor may request a waiver of any requirement of the IDE regulations through an application with supporting documentation. The FDA may grant a waiver if the requirement is not stipulated by the Federal Food, Drug, and Cosmetic (FD&C Act) or if it is not necessary for the protection of human subjects. [3]

FDA

The Premier Consulting Blog

OCTOBER 11, 2022

The treatment had been granted breakthrough therapy designation, but FDA approval would ultimately rest on the sponsor’s ability to demonstrate clinically meaningful improvement. The agency requested that data be further standardized and presented by primary functional endpoint. The FDA also granted a second meeting for review.

Disease

PPD

AUGUST 5, 2024

Food and Drug Administration (FDA)-approved therapies for treating PAH were primarily vasodilators, designed to overcome the imbalance between vasoactive and vasodilator mediators and to restore endothelial cell function. RHC: Right heart catheterization presents various challenges that can be addressed through specific solutions.

Clinical Trials

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

FDA explained that its bioequivalence regulations at 21 C.F.R. Those regulations break “concentration” out from strength but only in certain contexts. solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.” It was not too long ago that FDA punted on BI’s petition.

FDA

FDA Law Blog: Biosimilars

OCTOBER 1, 2024

The ramifications of the Federal Claims case and some of the other lawsuits brought by Vanda could be significant to regulated industry and to the food and drug bar. FOOD AND DRUG ADMINISTRATION et al Challenge to FDA approval of generic Hetlioz (tasimelteon) Pending 1:2023cv00629 (COFC) VANDA PHARMACEUTICALS, INC.

Government

FDA Law Blog: Biosimilars

JANUARY 18, 2024

The company asserts that carbadox residues fall below dangerous levels before the products hit consumers’ plates, and that the Agency’s anti-carbadox bias and failure to follow the mandated regulatory procedures violated the “the FDCA, FDA’s regulations, the APA, and due process.” Carbadox has had a tortured approval history.

FDA

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 Law Blog: Biosimilars

APRIL 21, 2024

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ).

FDA

The Pharma Data

JANUARY 5, 2021

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. A live webcast presentation can also be accessed via the Investors section of the Radius’ corporate web site at: [link].

Disease

The Pharma Data

APRIL 8, 2021

Additional presentations on investigational programmes, including Alzheimer’s disease and Huntington’s disease, help advance scientific understanding of neurological disorders. Roche will present data from five studies from the EVRYSDI clinical development programme, which was designed to represent a broad spectrum of people living with SMA.

Clinical Trials

FDA Law Blog: Biosimilars

AUGUST 17, 2023

This statutory provision requires generic drugs to have the same labeling as that approved for the listed drug “except for changes required because of differences approved under a [suitability petition, allowing for certain differences] or because the new drug and the listed drug are produced or distributed by different manufacturers.”

FDA

Drug Target Review

JULY 5, 2024

Secondly, organoids lack a functional blood-brain barrier (BBB) and so a drug showing a response in the organoid might not be active in vivo where a BBB is present. Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene.

Drugs

The Pharma Data

SEPTEMBER 7, 2020

Novartis will present 48 abstracts from its leading MS portfolio, including new data on recently FDA-approved Kesimpta ® (ofatumumab) — the first and only self-administered, targeted B-cell therapy for relapsing forms of MS (RMS )— Mayzent ® (siponimod) and Gilenya ® (fingolimod) .

Therapies

Vial

JUNE 12, 2024

PROs, included in clinical trials as primary or secondary endpoints , are increasingly recognized by regulators, clinicians, and patients as valuable tools. Role of PROs in drug approvals A recent review sought to comprehensively characterize the inclusion of PROs and regulatory considerations in FDA-approved novel oncology drugs.

Clinical Trials

The Pharma Data

JANUARY 13, 2021

Brilacidin’s robust antimicrobial properties might also help to fight secondary bacterial infections, which can co-present in up to 20 percent of COVID-19 patients. and other pro-inflammatory cytokines and chemokines, which have been identified as central drivers in the worsening prognoses of hospitalized COVID-19 patients.

Clinical Trials

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

Agency IQ

JUNE 7, 2024

BY CHELSEY MCINTYRE, PHARMD | JUN 3, 2024 8:43 PM CDT Regulatory background: DSHEA and dietary supplements The Dietary Supplement Health and Education Act ( DSHEA ) of 1994 defines the FDA’s authority in the regulation of dietary supplement products and dietary ingredients. See AgencyIQ’s analysis of the draft guidance here. ]

FDA

The Pharma Data

NOVEMBER 5, 2020

FDA approval, and customary exceptions). The publication presents real-world evidence related to abuse, misuse and diversion of Xtampza ER assessed using Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS ® ) system data sources. Collegium’s headquarters are located in Stoughton, Massachusetts.

Pharmaceuticals

The Pharma Data

FEBRUARY 4, 2021

“We successfully completed the transformative Allergan acquisition and delivered another year of strong results in 2020, despite the challenges presented by the global pandemic,” said Richard A. NORTH CHICAGO, Ill., Gonzalez , chairman and chief executive officer, AbbVie. ” Fourth-Quarter Results.

Production

Agency IQ

JANUARY 4, 2024

For regulators, there are two primary concerns associated with impurities – that they may cause a drug substance to degrade (thereby reducing its efficacy or safety) and that the impurities (or their effects on the drug substance) may be harmful to patients. Read AgencyIQ’s analysis of the ICH guideline here ].

FDA

Agency IQ

APRIL 26, 2024

For context, while prescription drug products are required to comply with FDA’s regulatory requirements around labeling and approval (see 21 CFR 201 ), promotional materials and advertisements are regulated differently (under 21 CFR 202.1(1)(2) Yes, the guidance confirms.

Biosimilars

The Pharma Data

OCTOBER 29, 2020

ULTOMIRIS – Atypical Hemolytic Uremic Syndrome (aHUS): In September 2020 , Japan’s MHLW approved ULTOMIRIS for adults and children with aHUS. FDA approved the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS. A global Phase 3 study of ULTOMIRIS in children and adolescents with aHUS is underway.

Clinical Trials

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

Regulations

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval

The Pharma Data

JANUARY 21, 2021

Results from these trials were presented at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI). “CABENUVA once-monthly injections showed comparable efficacy to daily oral antiretroviral treatment in maintaining viral suppression – a first in the treatment paradigm.”

FDA Approval