Drug Discovery World

NOVEMBER 29, 2022

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering. Starting with the drug. Pharmacokinetics: How the body handles drugs.

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Fierce BioTech

JUNE 22, 2023

Accelerating Patient Identification and Improving Health Outcomes for Orphan Drug Candidates in Europe. pesurya Thu, 06/22/2023 - 12:49 Wed, 08/02/2023 - 14:00 Resource Type Webinar Duration 60 Minutes Identifying orphan drug candidates and optimizing treatment adherence can be challenging in the best of circumstances.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products.

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Drug Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

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The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales ( STAT ). US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ). What happens now?

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Common Sense for Drug Policy Blog

JANUARY 5, 2024

Part of this 'performance' has to do with adapting to the different temporal demands of the labor market—in other words, the management of sleep and wakefulness. Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. As Crary ( 2013 , p. As Crary ( 2013 , p. 2020;183-213.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Biosimilars marketed in the U.S. More than 34 million people in the U.S.

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The Pharma Data

MAY 27, 2022

Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. Today, the U.S. We continue to work closely with our U.S. as quickly as possible.

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Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below.

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Agency IQ

NOVEMBER 27, 2023

The changes, which should take effect in mid-2024, should result in drug ads with fewer distracting elements and more emphasis on the major risks of the drug. These requirements are further established under 21 CFR 202.1 , which outline FDA’s expectations for prescription drug advertising.

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The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. . DMT (N,N-dimethyltryptamine). Prof. ” Prof. XPhyto Therapeutics Corp.

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The Pharma Data

MAY 13, 2021

Indian states turn to anti-parasitic drug to fight COVID-19 against WHO advice ( Reuters ). Japan vaccine chief blames drug approval system for slow inoculation drive ( Reuters ). Vaccine waiver talks can make drug firms the heroes, US trade chief says ( Reuters ) ( Law360 ). Medtech.

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The Pharma Data

JANUARY 24, 2021

Food and Drug Administration (“FDA”) approval. Sairiyo is advancing the clinical development of its lead drug candidate, Cepharanthine, a repurposed and reformulated naturally derived compound for the potential treatment of cancer, neurological, inflammatory and infectious diseases. PharmaDrug Inc.

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The Pharma Data

JANUARY 17, 2021

The new drug would provide immediate post-exposure protection against the virus and would be especially useful as a complement to the vaccine in the early phase after vaccination. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services in more than 100 countries.

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Drug Discovery World

JULY 27, 2023

Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). This agreement is called the Windsor Framework.

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The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If In July, finerenone was approved under the name Kerendia® by the us (U.S.)

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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 anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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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. What is drug compounding?

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

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FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

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Drug Discovery World

JUNE 20, 2024

billion 1 is the estimated cost of bringing a new drug from the drawing board to pharmacy shelves today. The fusion of LLMs with clinical research processes marks a significant evolution and can help us reshape our approach to drug development and patient care. RBC Capital Markets. Accessed Jan 2024. Accessed Feb 2024.

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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. December also typically brings end-of-year perspectives on the agency’s accomplishments.

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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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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

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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. There are as many PDUFA dates in November and December as we’ve seen all year.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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The Pharma Data

MAY 13, 2021

I’ll also show you why their top scientists are now saying that this breakthrough treatment could replace traditional medical approaches for a wide range of painful conditions… What this means is that you can now say goodbye to your daily aches and pains without harmful drugs or having to resort to painful surgery. he continued.

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This list is known as the FDA’s “guidance agenda.”

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Codon

APRIL 9, 2023

Sponge cells double in population quite quickly — around 40 minutes — and could be engineered to manufacture drugs. Read Probe-based bacterial single-cell RNA sequencing predicts toxin regulation. A programmable and red light-regulated CRISPR-dCas9 system for the activation of endogenous genes in Saccharomyces cerevisiae.

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Agency IQ

DECEMBER 11, 2023

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. As more data have been collected on products previously approved, regulators have started to look back at them with a more critical gaze.

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Agency IQ

FEBRUARY 15, 2024

Priority A List.

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Advarra

DECEMBER 14, 2022

Pharmacy manual. drugs and biologicals. The investigational agent in the trial has an FDA-issued investigational new drug (IND) approval and associated six-digit number. The investigational agent is considered IND exempt per the following criteria : The drug is lawfully marketed in the United States. Lab manual.

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Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

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Drug & Device Law

MAY 19, 2023

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN. In GenBioPro, Inc.

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Drug & Device Law

JULY 18, 2022

841’s “knowingly or intentionally” scienter (that’s legal Latin for the degree of intent required for a crime or tort) requirement for illegal drug distribution. ii) adulterated or misbranded drugs that are –. * * * *. (II) Emphasis added). 21 U.S.C. §§321(i), See , e.g. , 21 C.F.R. 201.128, 801.4.

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