Drug Target Review

MARCH 12, 2024

Bile acids are crucial signalling molecules that aid the regulation of the immune system and have essential metabolic functions, like controlling lipid and glucose metabolism. 2023 February 5 [2024 March 11]; 15(1). 2023 December 9 [2024 March 11] Available from: [link] 3 Abiead Y, Aiosa N, Antunes E, et al. Gut Microbes.

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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] Food and Drug Administration (FDA). Retrieved 18 October 2023.

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DrugBank

MAY 6, 2024

A Wave of Innovations The year 2024 has already proven to be significant for the field of biologics, witnessing a notable increase in FDA approvals. In the first quarter alone, the FDA approved 9 new biologics, a substantial rise from the 5 approvals during the same period in 2023.

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Drug Discovery World

APRIL 14, 2023

Pettit Nassi and Perlmutter will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. The team will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. Wherry’s award lecture will be held on Monday April 17 at 3:30pm ET.

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Drug Discovery World

AUGUST 3, 2023

Medical cannabis is often a first-thought when regarding plant-based medicines, but there remains public scepticism, arguably due to the regulations relating to the substance. For example, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition to date 1.

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FDA Law Blog: Biosimilars

MAY 15, 2023

By Riëtte van Laack — For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials. AAFCO develops model regulations, that serve as model for the states.

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FDA Law Blog: Biosimilars

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. In fact, federal law and regulation appear to require AbbVie to list these patents.”

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FDA Law Blog: Biosimilars

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. 10,968,453 (November 29, 2023) Pursuant to 37 C.F.R. 27, 1995); aff’d , 109 F.3d

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The Premier Consulting Blog

NOVEMBER 12, 2023

This feedback prompted the FDA to release a second paper in 2021 titled “ Artificial Intelligence/Machine Learning (AI.ML)-Based Software as a Medical Device (SaMD) Action Plan ,” which outlined the agency’s five-pillar approach to regulating AI/ML. AI will be able to identify trends in manufacturing-related deviations. (

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FDA Law Blog: Biosimilars

MARCH 26, 2024

In a seemingly run of the mill patent suit, Teva sued Amneal for infringement of 5 patents arising from the submission of Amneal’s ANDA referencing Teva’s combination product ProAir HFA NDA in fall 2023. Because a “drug product” is defined by regulation as a “Finished dosage form.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). FDA regulations, at 21 C.F.R. Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling. 355(j)(2)(A)(v).

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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Drug Target Review

JULY 5, 2024

Interneuron migration is regulated by L-type calcium channels (LTCCs), encoded by the CACNA1C gene. Recently, a network-based drug-screening platform has been developed to test FDA-approved drugs for Alzheimer’s disease (AD) using 1,300 iPSC-derived organoids from 11 sporadic AD patients. 12(3) (2023). 23(24):9842 (2023).

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

That Policy Statement , issued on September 14, 2023, warns companies that improper listing of patents in the Orange Book could be “ an unfair method of competition in violation of the FTC Act ”. The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the.

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Agency IQ

SEPTEMBER 15, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 11, 2023 6:44 PM CDT Regulatory background: User fees and over-the-counter (OTC) drug reform Quick background: The FDA collects user fees as part of an essential bargain between regulators and industry. Industry wants its products reviewed quickly, efficiently and predictably.

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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. According to the FDA , this contract was awarded and is nearing completion.

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KIF1A

JULY 1, 2023

This activity may be regulated by the K-loop, which is known to be important for KIF1A’s long-range movement. Taking a drug that shelved during development or didn’t receive FDA approval, and assessing its application for another disease, is called drug repositioning.

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Agency IQ

NOVEMBER 3, 2023

BY CHELSEY MCINTYRE, PHARMD | OCT 30, 2023 10:57 PM CDT Background: What are microbiome-based therapies? In 2022, the FDA approved the first LBP – Rebyota (RBX2660; Ferring Pharmaceuticals) – but has yet to approve a recombinant LBP. The regulation of dietary supplements in the U.S. What is the microbiome itself?

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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.,

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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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 latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Drug Discovery World

JUNE 12, 2024

In March 2024, Novo Nordisk’s anti-obesity GLP-1RA drug, Wegovy, received FDA approval for its potential to reduce cardiovascular risks in patients without diabetes.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Codon

AUGUST 26, 2024

Nature Materials (2023). Broad-spectrum antiviral drugs often have trouble finding pre-existing markets because regulators and consumers favor drugs that treat specific diseases, rather than drugs that have broad applicability. As a result, it is classified as a “drug-free” product and does not require FDA approval.

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FDA Law Blog: Biosimilars

APRIL 30, 2023

Senate Committee on Health, Education, Labor and Pensions (“Senate HELP”) is scheduled to take up legislation that could significantly limit access to the courts and immunize critical FDA decisions from timely judicial review. That bill is S.

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The Anticancer Fund

JUNE 23, 2023

23 June 2023 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. They screened 20 FDA approved AEDs against a panel of six patient-derived IDHmut glioma stem-like cells. It is one of the focus areas of the Anticancer Fund.

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Agency IQ

DECEMBER 1, 2023

Revisions to this guidance reflect both the growing body of knowledge related to Covid-19 and some subtle shifts in FDA policy over the past few years. 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.

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KIF1A

JUNE 3, 2023

2023 This study has a small sample size from a single hospital, and there were patients who did not have available genetic data, so we can’t generalize these statistics too much. Read the Article The post #ScienceSaturday: June 3, 2023 appeared first on KIF1A. Genes associated with Pure and Complex HSP. Ikeda et al.

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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Drug Discovery World

APRIL 17, 2023

DDW’s Megan Thomas rounds up highlights from Monday 16 April at AACR 2023, from promising trial results for colorectal cancer patients to updates on Biden’s Cancer Moonshot initiative. The post Monday 17 April at AACR Annual Meeting 2023 appeared first on Drug Discovery World (DDW). Read more here.

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Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. A few months later in January 2023, the agency released a “ BsUFA Research Roadmap ,” which further outlined the specific action items under the pilot.

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Agency IQ

JANUARY 12, 2024

After lengthy review, FDA approves Florida’s drug importation plan After a years-long review process, the FDA today announced its approval of Florida’s proposal to import certain prescription drug products from Canada.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812 (b)(1).

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New Drug Approvals

DECEMBER 16, 2023

1 Factor B is a positive regulator of the alternative complement pathway, where it activates C3 convertase and subsequently C5 convertase. 2 On December 6th, 2023, Iptacopan under the brand name Fabhalta was approved by the FDA for the treatment of adults with PNH. 5 December 2023. 6 December 2023.

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The Pharma Data

JANUARY 24, 2021

Sairiyo recently received FDA orphan drug designation for Cepharanthine in the treatment of esophageal cancer. billion during 2019-2023 (Technavio 2019). Persons”, as such term is defined in Regulations under the U.S. The global esophageal cancer drugs market is estimated to grow by USD $1.5

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. By Larry K.

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