BioPharma Drive: Drug Pricing

MAY 22, 2024

The deal, only Biogen’s third since the start of 2018, is a sign the company is open to branching out beyond the neurological drugs that have long been its focus.

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BioPharma Drive: Drug Pricing

OCTOBER 4, 2024

Having already been on a winding journey, Enjaymo, which Sanofi acquired through a 2018 buyout of Bioverativ, is now headed to Recordati as part of a deal announced Friday.

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Disease Drugs 167

BioPharma Drive: Drug Pricing

MARCH 17, 2024

The biotech, formed as a successor to a company Roche acquired in 2018, has two drugs in clinical testing for neurological and immune diseases.

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Disease Drugs 201

Covalent Modifiers

FEBRUARY 6, 2024

3c04710 Covalent drug discovery has been a challenging research area given the struggle of finding a sweet balance between selectivity and reactivity for these drugs, the lack of which often leads to off-target activities and hence undesirable side effects. Recent developments in in silico methods provide promise in this direction.

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Drugs Research 182

Crown Bioscience

JUNE 6, 2024

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023.

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FDA Approval FDA Drugs Research 105

Drug Hunter

JUNE 5, 2023

Macrocyclic molecules, containing 12 or more atoms in a ring system, are increasingly prevalent in drug discovery, with over 67 macrocyclic drugs approved so far and several notable examples of clinical success highlighted on Drug Hunter recently, including MK-0616 , repotrectinib , and pacritinib.

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Process Chemistry Drugs Production Clinical Development 206

Agency IQ

SEPTEMBER 22, 2023

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling. Fill out the form to read the full article.

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Drug Hunter

AUGUST 21, 2023

Obtaining adequate drug exposure in the brain is key to treating CNS diseases effectively. Recently, Dennis Koester gave us a crash course in CNS drug discovery in a Drug Hunter Flash Talk. Why Kp,uu is the Most Important Parameter in CNS Drug Discovery What Influences the Kp,uu of Drugs?

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Drugs Disease Targeted Protein Degradation Screening Hits 206

The Pharma Data

NOVEMBER 17, 2020

17, 2020 — From 2009 to 2018, there were increases in diseases-of-despair diagnoses, according to a study published online Nov. The prevalence of alcohol-related, substance-related, and suicide-related diagnoses increased by 37, 94, and 170 percent, respectively, from 2009 to 2018. TUESDAY, Nov. 9 in BM J Open. © 2020 HealthDay.

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Drug Target Review

SEPTEMBER 26, 2023

These cells demonstrate considerable promise for uncovering drug-induced perturbations to neuronal function such as seizure, and their use extends further to sedation, anti-epileptic drug discovery and modelling of neurological diseases.

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Drugs FDA Disease Animal Testing 112

Broad Institute

JANUARY 22, 2024

At the Broad Institute of MIT and Harvard and elsewhere, researchers are also learning how dependencies affect cancer cells and how they influence each other and contribute to drug resistance. You’d need to disable both genes to see how important they are as a drug target. We miss that combinatorial dependence in our current screens.

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Drugs Therapies Regulations RNA 128

Advarra

JULY 26, 2022

However, it’s not legal federally and is considered a Schedule I drug by the U.S. Drug Enforcement Administration (DEA), meaning it has no accepted medical use and a high potential for abuse. The 2018 Farm Bill. The 2018 Farm Bill removed hemp from the Controlled Substance Act. Funding Research on Cannabis.

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Regulations Research FDA FDA Approval 97

Drug Target Review

SEPTEMBER 20, 2023

“AI will not replace drug discovery scientists, but drug discovery scientists who use AI will replace those who don’t” – comment during EFMC meeting 2018 Progressing a drug molecule from concept to commercialisation typically takes 10-15 years and has high associated costs of up to $2 billion per launched drug, if all failures are factored in.

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Drugs Metabolic Stability Computational Chemistry Pharmaceuticals 105

Antidote

JULY 29, 2022

The process of getting a new drug to market is an expensive one. Between 2009 and 2018, U.S. biopharmaceutical companies spent about $1 billion per drug according to an analysis published in JAMA , and other studies have found that it can cost up to $2.8 billion to bring a new therapy to market.

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Clinical Trials Trials Therapies Pharmaceuticals 96

Drug Channels

JULY 6, 2022

The boom in copay accumulators and maximizers has radically shifted payers’ views on manufacturers’ copay support programs for specialty drugs. Below, I review a new survey of commercial plan sponsors and contrast the findings to a comparable survey from 2018. d/b/a Drug Channels Institute. to 1:30 p.m.

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Drugs 98

Drug Patent Watch

NOVEMBER 9, 2023

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2018 to 2023. Companies that successfully challenge patents on branded drugs are granted six… The post Most prolific drug patent challengers appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Companies Drugs Pharmaceuticals 59

Agency IQ

SEPTEMBER 22, 2023

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling.

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Drug Target Review

JULY 13, 2023

Drug discovery is a complex and vital field that continually seeks to identify new therapeutic targets and develop effective treatments. In recent years, a novel approach known as condensate biology has emerged, revolutionising the way researchers think about drug discovery and development.

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Disease Small Molecule Cell Biology Drugs 98

FDA Law Blog: Drug Discovery

JULY 17, 2024

An Opportunity to Leverage the Newly Created Rare Disease Advisory Committee across CDER and CBER In Frank and James’ 2018 proposal there was also a recommendation for the formation of a Rare Disease Advisory Committee, which would allow FDA access to experts in the science of small trials and other aspects of rare disease research.

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FDA Disease Clinical Pharmacology Science 105

PPD

SEPTEMBER 6, 2023

Mixing of service models — a strategy that drug developers are leveraging now more than ever — can bring life-changing therapies to market faster. In 2018, market utilization of FSO models was at 72%, with usage of FSP models lagging at 28%. Growth of the FSP market is steadily increasing.

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Drug Development Clinical Trials Drugs Clinical Research 98

The Pharma Data

JANUARY 27, 2021

27, 2021 — The number of adverse drug reactions (ADRs) associated with hydroxychloroquine and chloroquine more than doubled in 2020 compared with 2018 and 2019, according to a research letter published online Jan. Food and Drug Administration Adverse Event Reporting System database from Jan. 1, 2018, to Sept.

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Drug Patent Watch

JULY 26, 2023

This chart shows the generic pharmaceutical companies that had the most successful drug patent challenges from 2018 to 2023. Companies that successfully challenge patents on branded drugs are granted six… The post Most prolific drug patent challengers appeared first on DrugPatentWatch - Make Better Decisions.

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Pharmaceutical Companies Drugs Pharmaceuticals 52

Eye on FDA

AUGUST 27, 2023

But in fact, as can be seen in previous years such as 2019, 2018 and 2015, the mid-year tally (in red) is not always predictive of what we may see by year’s end (in blue). Other Approvals – Of course, there are many drugs approved that are not NMEs and which do not have Advisory Committee meetings.

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FDA Drugs Treatment Therapies 78

Common Sense for Drug Policy Blog

DECEMBER 14, 2023

Drugs and Social Media "End users seem to be buying their drugs on the dark web to a lesser extent than in previous years.28 28 Qualitative information provided by people who use social media suggests that the use of such media for drug purchasing purposes has been increasing, especially at the retail level.29

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Drugs Marketing Production 52

Elrig

MAY 8, 2024

How does your genetics affect your weight and can drugs help? Insights from Giles Yeo How does your genetics affect your weight and can drugs help? Originally GLP1-like drugs were developed to treat Type-2 diabetes as it also triggers insulin production. If you stop taking the drug, won’t the weight come back?

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Drugs Science Research Disease 59

Drug Target Review

MARCH 3, 2025

The search for effective treatments for neurodegenerative diseases like Parkinson’s disease has long been hindered by the brain’s complexity and the absence of adequate models for drug discovery. “Then, the organoid model would be tested with, say, five, six, or seven drugs available on the market. .

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Disease Treatment Therapies Cell Biology 52

Fierce BioTech

SEPTEMBER 13, 2024

Highlights From the Final ICH Drug Interactions Guideline pesurya Fri, 09/13/2024 - 11:39 Thu, 10/31/2024 - 11:00 Resource Type Webinar Brian Ogilvie Graham Dyck Duration 60 Minutes The ICH M12 Guideline was finalized on May 21st, 2024, after extensive review of industry and other comments.

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Drugs FDA Drug Development 52

Plenge Gen

JANUARY 6, 2019

At the 2018 Annual Atlas Ventures Retreat (AVR), I participated in a panel on Digital Health (along with David Schenkhein, John Reed, Scott Brun). While there are many aspects to digital health, we focused on the application to drug discovery and development. What is digital health in relation to drug discovery & development?

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Drugs Production Drug Development 52

Drug Target Review

NOVEMBER 1, 2023

3 Another recent development is the implication of ATX in neurological diseases, 6,7 as ATX levels are related to metabolic disorders in Alzheimer disease, and thus might be an interesting biomarker and drug target for this devasting pathology. 2018 Jun 13;5. 2018 Sep;37(2–3):509–18. References: Ninou I, Magkrioti C, Aidinis V.

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Clinical Trials Trials Small Molecule Disease 134

NIH Director's Blog: Drug Development

NOVEMBER 15, 2018

They’re synthesized in the lab, allowing Wimley and team to tweak their chemical structures and hopefully create ones with therapeutic potential, particularly as smart-delivery systems to target cells with greater precision and deliver biological cargoes such as drugs [1]. 2018 Jul 2;9(1):2568. [2] How can he tell the difference?

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Science Drugs Disease Therapies 52

Drug Target Review

JANUARY 25, 2024

The peptide in development is based on a 2018 Cleveland Clinic discovery and serves as a proof-of-concept for this type of drug for triple-negative breast cancer. 2 The cells of this cancer lack certain receptors so drugs designed to treat other subtypes of breast cancer will not work.

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Treatment Clinical Trials Science Research 106

Eye on FDA

JULY 28, 2020

By March we were remaining at home, including people who worked at FDA who assess new drugs for approval. Now after six months of the COVID-19 pandemic, one might have expected that the approval of new medicines by the Food and Drug Administration might have been negatively impacted as a result. But of course, that is what happened.

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FDA Drugs 56

DrugBaron

FEBRUARY 16, 2021

More than a hundred antibodies have now been approved as drugs, making up around a third of all approvals over the last three years. Winter, together with George Smith and Frances Arnold, was also duly recognised with a Nobel Prize for this work in 2018. And many times, we don’t do a very good job even still.

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Molecular Biology Small Molecule Engineering Laboratories 130

Common Sense for Drug Policy Blog

AUGUST 22, 2023

Drug Checking Services "One of the consequences of drug prohibition is the lack of knowledge regarding the composition and purity of illicit substances ( Miron, 2003 ; Taylor et al., In the context of harm reduction, drug checking has emerged as a strategy to address this issue.

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Drugs 40

Common Sense for Drug Policy Blog

NOVEMBER 10, 2023

In 2017, the UN Committee on Economic, Social and Cultural Rights recommended that Russia change its punitive policy approach with an 18-month transformation and to consider decriminalising drugs for personal consumption. Drug control and human rights in the Russian Federation. But nothing has really changed. Nordisk Alkohol Nark.

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Drugs Science 40

The Pharma Data

MAY 5, 2021

FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of Generic Drugs (OGD) has increased steadily since FY 2013. In FY 2019, 252 were issued, as were 208 in FY 2018. . FDA webinar on product specific guidance for generic drugs . Source link.

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Drug Development FDA Drugs Production 52

New Drug Approvals

OCTOBER 12, 2024

2018; 32(9): 849–861. [2]. 2018 Mar;57(3):315-333. Tramiprosate was reported to inhibit Aβ42 aggregation into toxic oligomers ( Gervais et al., 2007 ; Kocis et al., Both ALZ-801 and tramiprosate are metabolized to 3-sulfopranpanoic acid (3-SPA), which is normally found in brain and also inhibits Aβ42 aggregation ( Hey et al.,

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Pharmacokinetics Small Molecule Disease Licensing 62