ProRelix Research

NOVEMBER 27, 2023

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

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Drug Discovery World

AUGUST 13, 2024

Animal models (AMs) have generally been seen as useful for drug development and biomedical research for many years. These assumptions have led to the development of a common orthodoxy within the pharmaceutical community – that AMs help to de-risk drug development by providing a way of assessing translatability into humans.

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Drug Discovery World

NOVEMBER 8, 2023

KT-110’s mode of action is novel to Alcohol Use Disorder (AUD) and works by simultaneously modulating the noradrenergic and serotonergic brain receptors that counteract the neurobiological processes involved in addiction by regulating the secretion of dopamine.

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BioPharma Drive: Drug Pricing

JULY 9, 2024

On Tuesday, regulators updated the public on their yearslong probe of PBM's business practices. The report faults PBMs for profiting at the expense of patients and independent pharmacists.

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Chemical Biology and Drug Design

SEPTEMBER 30, 2023

Abstract Epigenetic regulation of genes through posttranslational regulation of proteins is a well-explored approach for disease treatment, particularly in cancer chemotherapy. Histone deacetylases have shown significant potential as effective drug targets in therapeutic studies aiming to restore epigenetic normality in oncology.

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BioPharma Drive: Drug Pricing

JULY 26, 2024

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

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Cytel

OCTOBER 11, 2023

Moving beyond static evidence development to ensure local market access success; responding to recent changes in governmental drug regulations and the role of automation Written by Grammati Sarri and Radek Wasiak The worldwide drug regulation landscape is rapidly changing.

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Drug Discovery World

JANUARY 4, 2024

The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) new International Recognition procedure (IRP) will allow it to draw on the expertise of regulators in other countries when authorising medicines. The post New UK authorisation procedure will draw on international drug approvals appeared first on Drug Discovery World (DDW).

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Common Sense for Drug Policy Blog

JUNE 6, 2024

Image and Performance Enhancing Drugs and Social Media Marketing "The final theme emanating from this exploration is the notable affordances and ‘malaffordances’ of both platforms that facilitate IPED supply. This has potentially negative consequences for the safety of users and the regulation of the market."

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Common Sense for Drug Policy Blog

JUNE 6, 2024

The Market for Image and Performance Enhancing Drugs (IPEDs) "The market for image and performance enhancing drugs has undergone seismic changes in the last two decades and, as has been alluded to above, its partial digitisation has created something of a dual space of commerce (Gibbs, Forthcoming ). 2014 ; Begley et al.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? Just over a month ago, the European Commission released its proposal for the new pharmaceutical directive and regulation. Fill out the form to read the full article.

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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. Even though CBD doesn’t meet criteria for IND exemption or the FDA’s OTC drug review, it still can be studied in humans.

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Drug Discovery World

FEBRUARY 19, 2024

Dr Julie Warner is Vice President of Regulatory Affairs at drug development consultancy, Boyds. In this article, she provides her expert insights into the key trends and developments expected to shape the global drug development industry this year. antibody-drug conjugate [ADC] pipelines in some oncology settings).

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Drug Discovery World

MAY 6, 2024

In this article, DDW’s Diana Spencer highlights several prominent hotspots that are taking the lead on advancing European drug discovery and development. During the period 2016-2021, the Brazilian, Chinese and Indian markets grew by 11.7%, 6.7% respectively compared to an average market growth of 5.8% for the US market 2.

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Drug Discovery World

FEBRUARY 12, 2024

DDW’s Megan Thomas spoke to experts from the drug discovery industry about their predictions on what 2024 holds for our sector. In the upcoming year, we will see the expansion of new, more complex markets and updated requirements from regulators. The challenge is harnessing the power of AI within a highly regulated industry.

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Common Sense for Drug Policy Blog

FEBRUARY 14, 2024

Growth of Novel Potent Opioids (NPOs) in the Unregulated Drug Market "Novel potent opioids (NPOs) are novel nonfentanyl opioids in the illicit opioid supply. Synthetic opioids are one of the fastest growing classes of opioids being detected in patients in the emergency department (ED) with opioid overdose (OD).

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The Premier Consulting Blog

DECEMBER 28, 2023

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. Resources [1] US Food and Drug Administration. Available at [link]. [2]

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Drug Discovery World

NOVEMBER 3, 2023

News round-up for 30 October – 3 November by DDW Editor Reece Armstrong My news highlights this week feature a variety of exciting clinical trial results and launches that are examining therapies for much-needed disease areas, new drug approvals and even a space mission with a pharma twist.

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BioPharma Drive: Drug Pricing

JULY 10, 2024

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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The Premier Consulting Blog

JANUARY 22, 2024

In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval. Products which integrate devices with drugs and/or biologics present unique regulatory challenges.

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Elrig

JUNE 15, 2023

We're Hiring - Marketing & Sales Assistant We’re Hiring! We are looking for an Events Marketing & Inside Sales Assistant to support the Marketing Manager, Business Development and Operations Team in all ELRIG’s marketing and sales activities, as well as day to day implementation of marketing tasks.

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BioPharma Drive: Drug Pricing

DECEMBER 19, 2023

A decision by European regulators to revoke approvals for five generic versions of Biogen's multiple sclerosis medicine helps cement the drug's monopoly there through early 2025.

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FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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Common Sense for Drug Policy Blog

JUNE 13, 2023

We were unable to assert a causal relationship between law enforcement drug market disruptions and overdose, and our study was not designed to, but our results are consistent with other evidence of this association. 25 " dwf_admin Tue, 06/13/2023 - 15:57 Source Ray, B., Korzeniewski, S. Carroll, J. Del Pozo, B., doi.org/10.2105/AJPH.2023.307291

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Agency IQ

JULY 8, 2024

What we expect European regulators to do in July 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Agency IQ

AUGUST 2, 2024

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

JULY 20, 2023

The EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. The use of AI is rapidly developing in society and as regulators we see more and more applications in the field of medicines.

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

A review of FDA’s Postmarketing Requirements and Commitments database reveals that one of the most common reasons FDA requires postmarketing studies is to assess the impact of a drug on maternal and fetal outcomes when taken by pregnant women. For many drugs, both a registry and an outcomes study are required.

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Agency IQ

MAY 31, 2024

What we expect European regulators to do in June 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

MARCH 7, 2023

DDW Editor Reece Armstrong takes a look at Qatar’s drug discovery and life sciences market, exploring how the country is utilising innovative technologies in its approach to healthcare. The Middle East represents one of the world’s most lucrative markets for pharmaceuticals.

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Drug Channels

OCTOBER 6, 2020

The biosimilar market is finally beginning to fulfill its promise. The latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products. What’s more, manufacturers of reference products are cutting drug prices to defend their market shares.

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Drug Discovery World

OCTOBER 5, 2022

DDW Editor, Reece Armstrong, sits down with Brinter CEO Tomi Kalpio to learn about the company’s approach to bioprinting and how it can be used throughout drug discovery. . RA: How can bioprinting be used to shorten drug discovery timelines? . This allows researchers to identify the best individual drugs to treat the disease. .

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Agency IQ

MARCH 1, 2024

What we expect European regulators to do in March 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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Drug Discovery World

FEBRUARY 22, 2023

Craig Caceci, Managing Director at Terebellum, offers guidance to pharmaceutical companies that are in the position to take their drugs to market. The challenges are even greater in the case of orphan drugs where patients need to be identified; therefore, emphasis is on diagnosis. before 18 months.

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Drug Target Review

JULY 4, 2023

Over the last two decades, an increasing number of Antibody Drug Conjugate (ADC) therapeutics have been approved for oncology indications. These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. 3D rendering of Antibody Drug Conjugate Molecules.

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Drug Channels

DECEMBER 17, 2020

This week, I’m rerunning some popular posts while I prepare for this Friday’s video webinar: Drug Channels Outlook 2021. Drug pricing perceptions always seem to lag reality. The biosimilar market is finally beginning to fulfill its promise. d/b/a Drug Channels Institute. As you will see below, Dr. Gottlieb was right.

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Drug Discovery World

MAY 22, 2024

The keynote speakers will be Luis Serrano from the Centre for Genomic Regulation, Serrano Lab, and Maria Flocco PhD, from AstraZeneca. Diana Spencer, Senior Digital Content Editor, DDW The post SLAS Europe reveals New Product Award finalists appeared first on Drug Discovery World (DDW).

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