FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. Specifically, Boehringer asked FDA to interpret “strength” for biosimilars to mean “total drug content” to the exclusion of “concentration.” mg/mL) for liquid parenteral drug products.

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The Pharma Data

NOVEMBER 10, 2020

10, 2020 — Even before the coronavirus pandemic began, Americans were already suffering: A new study reports that alcohol and drug misuse were up dramatically, and suicidal thoughts and behaviors were up 170% between 2009 and… Source link. TUESDAY, Nov.

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Elrig

APRIL 7, 2025

ELRIG Appoints Dr Del Trezise as Chair ELRIG Appoints Dr Del Trezise as Chair New leadership to drive continued growth and collaboration in drug discovery Cambridge, UK, 08 April 2025: ELRIG, a not-for-profit, volunteer-led organisation dedicated to the drug discovery community, has appointed Dr Del Trezise as Chair of the Board.

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Eye on FDA

SEPTEMBER 28, 2022

FDA published notice recently that the Office of Prescription Drug Promotion (OPDP) was proposing some new research related to the promotion of medicines by pharmaceutical companies. That is particularly true given that the 2009 framework has only been partially addressed by the agency. A full list can be found here.

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The Pharma Data

AUGUST 21, 2020

The US regulator originally approved the drug in 2009 for the treatment of chronic lymphocytic leukaemia as an intravenous infusion with a high dose that was administered by a healthcare provider. The drug is expected to be available in early September and set for a European regulatory review next year. Conor Kavanagh.

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FDA Law Blog: Biosimilars

MARCH 7, 2024

Sasinowski — In 2009 — 15 years ago — the National Organization for Rare Disorders (NORD) announced the first U.S. In 2009 I served as Chair of NORD and through the hard work of countless colleagues we inaugurated the first Rare Disease Day. By Frank J. recognition of Rare Disease Day.

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Common Sense for Drug Policy Blog

AUGUST 22, 2023

Harm Reduction Services for People Who Use Anabolic-Androgenic Steroids (AAS) and Performance- and Image-Enhancing Drugs (PIEDS) "Creating a bridge between public health and drug policy in the context of AAS would be a significant step towards providing adequate healthcare to this, often overlooked, group of substance consumers ( Dunn et al.,

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The Pharma Data

AUGUST 20, 2020

The FDA has approved its first generic of Biogen’s multiple sclerosis (MS) treatment Tecfidera, awarding authorisation to Mylan which is launching the drug in a dimethyl fumarate delayed-release oral solid formulation, both in 120mg and 240mg doses. The drug generated $3.79 billion for Biogen through 2019. Matt Fellows. Source link.

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The Pharma Data

OCTOBER 23, 2020

Johnson has served as the president and the chief executive officer of the Parenteral Drug Association since 2009. Mr. Johnson specializes in United States and international drug regulatory requirements, quality practices and technical operations.

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The Pharma Data

SEPTEMBER 30, 2020

This followed Jefferson and Cochrane’s years-long campaign which urged Roche to release all the Tamiflu data so the non-profit could assess the drug’s clinical value. The non-profit went as far to push a boycott of the flu drug. . billion on stockpiling the drug. billion in revenue in 2009 as the H1N1 flu spread. .

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Advarra

FEBRUARY 22, 2024

In 2009, the Food and Drug Administration (FDA) released a  guidance document on AE reporting to IRBs. Moreover, the sponsor is more familiar with the drug’s mechanism of action, class effects, and other information. Who Should Assess AEs in Clinical Trials?

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Molecular Design

OCTOBER 20, 2024

Previous Next In an earlier post I considered what it might mean to describe drug design as AI-based. In that earlier post I noted that there’s a bit more to drug design than simply generating novel molecular structures and suggesting how the compounds should be synthesized.

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Eye on FDA

JANUARY 9, 2022

Once again it was a quiet year with respect to the FDA’s Office of Prescription Drug Programs (OPDP). In the latest published guidance agenda from the Center for Drug Evaluation and Research, the advertising and promotion category had no slated guidance efforts listed. in November 2009.

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PLOS: DNA Science

OCTOBER 17, 2024

Miplyffa (arimoclomol), an oral drug taken three times a day, is prescribed for patients with Niemann-Pick disease type 3, aka NPD3, two years of age and older. The first-ever approval of a safe and effective drug option will undoubtedly support the essential medical needs of those suffering.” Bluebird Bio developed the new drug.

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Drug Target Review

OCTOBER 17, 2024

Can you elaborate on the preclinical studies and data that led to development of drug candidates along the CD24/Siglec-10 pathway? We showed that ONC-781 can be used as a platform to develop multiple modalities, including bispecific T cell engager, antibody-drug conjugates and chimeric antigen receptor T cell (CAR-T).

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Broad Institute

OCTOBER 17, 2023

After the startup folded, Deik worked as an analytical chemist at a drug-repositioning company called Gene Logic, where she first met Clary Clish, who would later become the director of the Metabolomics Platform at the Broad Institute of MIT and Harvard.

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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 ). FDORA § 3209(a)(2).

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Common Sense for Drug Policy Blog

JUNE 4, 2023

Problematic drug use among this population has been extensively documented in the scientific literature (O'Flaherty et al., 2009 ; Krupski et al., Homelessness and drug misuse often coexist, and the recorded prevalence of drug use among homeless individuals in different countries is consistently above the national average (Doran et al.,

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Eye on FDA

FEBRUARY 10, 2021

Looking now to a review of enforcement by the Office of Prescription Drug Promotion (OPDP) in 2020, we see a different picture. The Violations – In recent years, there has been an uptick of activity aimed at the promotion of an unapproved drugs.

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Metabolite Tales Blog

JULY 4, 2024

First-ever identification of an aldehyde oxidase-mediated DDI Inhibition of aldehyde oxidase mediated metabolism of OS1-930 by erlotinib Where metabolic pathways have not been interrogated for drugs in development, unwelcome surprises may arise. Drug Metabol Drug Interact. link] Dihel L, Kittleson C, Mulvihill K, Johnson WW.

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Molecular Design

SEPTEMBER 27, 2023

The five days spent discussing computer-aided drug design (CADD) in Vermont are what I’ll be covering in this post and I think it’s worth saying something about what drugs need to do in order to function safely. It is indeed a small world.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

In the veterinary world, where rolling applications are common, the testing phase is usually particularly important because the review phase, which starts only when the last component of the rolling New Animal Drug Application (NADA)—called the Administrative NADA—is submitted, is short, typically around 60 days.

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Drug Target Review

JUNE 21, 2023

1 With novel emerging drug modalities further expanding the druggable genome, connecting the right target genes to a disease will only become more relevant. As most inherited diseases are caused by gene mutations that lead to a defect or loss of function, the benefit of using genetics to find new drug targets is compelling.

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The Pharma Data

JANUARY 20, 2021

CytomX has strategic drug discovery and development collaborations with AbbVie, Amgen, Astellas, and Bristol Myers Squibb. CD166 and CD71 are among cancer targets that are considered to be inaccessible to conventional antibody-drug conjugates due to their presence on many healthy tissues.

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Common Sense for Drug Policy Blog

SEPTEMBER 15, 2023

3 In Denver, Colorado, and Seattle, Washington, the increase in methamphetamine use has predominantly involved a growing proportion of people who inject drugs (PWID) using both methamphetamine and heroin, either separately or in a single injection commonly known as a goofball. 1 , 2 (Goofball can also be smoked.) Am J Addict.

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Molecular Design

JANUARY 16, 2019

I’ll be taking a look at machine learning (ML) in this post which was prompted by AI in Drug Discovery - A Practical View From the Trenches by Pat Walters in Practical Cheminformatics. Pat’s post appears to be triggered by Artificial Intelligence in Drug Design - The Storm Before the Calm? by Ash at Curious Wavefunction. pIC50 = 6.6).

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FDA Law Blog: Biosimilars

OCTOBER 24, 2023

Previous iterations of this guidance from 2009 and 2014 (blogged on here and here ) were known as Good Reprint Practices (GRP).

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The Pharma Data

APRIL 6, 2021

Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD). The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

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Drug Target Review

JANUARY 24, 2024

Although such drugs exist, he continued, they would need to be tested in animal models and improved. 2009 February 20 [2024 January 18]; 136(4):777-793. sRNAs Cellular functions rely on numerous protein-coding and noncoding RNAs and the RNA-binding proteins associated with them, which form ribonucleoprotein complexes (RNPs).

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DrugBank

JUNE 27, 2023

The general notion is that patients should be viewed individually, rather than strictly as members of some larger general population, and that their specific genetic background, environment, and lifestyle choices should be considered throughout drug development to the point of treatment and continuing patient care.

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New Drug Approvals

SEPTEMBER 13, 2024

8] [9] [10] The drug has been found to dose-dependently block fentanyl -induced miosis at 25 mg and 60 mg in humans (with minimal to no blockade at doses of 4 to 10 mg), suggesting that the drug significantly occupies and antagonizes the MOR at a dose of at least 25 mg but not of 10 mg or less. [10] 2] Aticaprant is taken by mouth. [1]

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Drug Target Review

JUNE 29, 2023

Looking back, at the way we approach safety in preclinical testing and in IND (investigation new drug) submissions was really changed by those papers. If you think about how chemotherapy has bloomed in oncology, you think about how antibody protein drugs have bloomed, and I think cell therapy is the next frontier.

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Common Sense for Drug Policy Blog

DECEMBER 28, 2023

A 2001 study of alcohol abuse and dependence among US adults using the National Household Survey on Drug Abuse (NHSDA) — the precursor to the NSDUH — found that the prevalence of alcohol dependence was 7.4% Prevalence of Alcohol Dependence Among US Adult Drinkers, 2009–2011. among men and 7.3% Prev Chronic Dis 2014;11:140329.

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The Pharma Data

MAY 14, 2021

Description: Copyright © 2009 – 2021 BeatKidneyDisease.com All Rights Reserved. These statements have not been evaluated by the Food and Drug Administration. ClickBank is the retailer of products on this site. CLICKBANK® is a registered trademark of Click Sales Inc., a Delaware corporation located at 1444 S.

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The Pharma Data

DECEMBER 8, 2020

” Gilbert added, “Here we have shown for the first time that an adenoviral vectored vaccine — a type of vaccine technology which has been in use since 2009 — is efficacious and could contribute to disease control in the COVID-19 pandemic.” Food and Drug Administration’s website in advance of a Dec.

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The Pharma Data

APRIL 24, 2021

In 1999, Novartis launched the first fixed-dose Artemisinin-based Combination Therapy (ACT) and in 2009, the first dispersible pediatric ACT developed in partnership with Medicines for Malaria Venture (MMV). Novartis is advancing Research & Development of next-generation treatments to combat emerging drug resistance.

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The Premier Consulting Blog

OCTOBER 21, 2024

Accelerated approval is an expedited regulatory pathway designed to hasten the availability of drugs (including biologics) that treat serious conditions, offer advantages over existing therapies, and address unmet medical needs.

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