Drug Discovery World

APRIL 10, 2023

Could India become an important centre of drug discovery innovation? India is traditionally known as ‘the pharmacy of the world’ due to its huge pharmaceuticals manufacturing capacity and high quantity of exports, particularly generic medicines and vaccines. In 2021, a DDW article stated: “There is work to be done.

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Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Click here to download a free report overview (including a summary of industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: U.S.

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Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. pharmaceutical distribution industry. Special preorder and launch pricing discounts will be valid through October 20, 2023.

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Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Electronic security access to the pharmacy and video monitoring. -

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Drug Channels

MAY 21, 2024

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook This event will be broadcast live on Friday, June 21, 2024, from 12:00 p.m. Pharmacies and Pharmacy Benefit Managers.

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Drug Channels

OCTOBER 3, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on our new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Will payers let Humira go?

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Drug Channels

OCTOBER 2, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on DCI's new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Click here to see the original post from May 2023. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Drug Channels

AUGUST 8, 2023

on the overall market, explained channel distortions from 340B contract pharmacies, and offered some policy recommendations. Click here to read the Drug Channels Institute letter to Senators Thune, Stabenow, Moore Capito, Baldwin, Moran, and Cardin. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. I shared my $0.02

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Drug Discovery World

NOVEMBER 8, 2023

This efficiency expedites the identification of potential therapeutic targets, screening of drug candidates, and selecting eligible trial participants, all of which are crucial aspects of clinical trial design and execution. Regulatory bodies can form a global consortium to standardise drug evaluation and approval processes.

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Drug Channels

MAY 24, 2023

In recent years, each of these companies has launched new group purchasing organizations (GPOs) to further consolidate the number of covered lives in rebate negotiations with pharmaceutical manufacturers. Read more » Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. to 1:30 p.m.

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DrugBank

NOVEMBER 7, 2023

EDMONTON, CANADA, November 1st, 2023— DrugBank today kicked off their role as a key distributor of the American Society for Health-System Pharmacists’s (ASHP) data. Discover ASHP Third-Party Packages in the Data Librar y ABOUT DRUGBANK DrugBank is the world’s first intelligent and comprehensive drug knowledge platform.

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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. There are many questions to ask.

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Drug Channels

OCTOBER 23, 2023

Informa Connect’s Trade and Channel Strategies Hybrid Event | December 11-13, 2023 DoubleTree By Hilton | Philadelphia, PA Exclusive Offer–Be sure to use your exclusive promo code 23DC10 to save 10% off* of your registration. Trade and Channel Strategies is back and we have a lot to talk about! What can you expect?

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Drug Discovery World

FEBRUARY 10, 2023

DDW Editor Reece Armstrong explores the Scandinavian drug discovery sector and speaks to key players about Sweden’s place in the market. Scandinavia represents one of the most exciting but perhaps underrepresented markets for the discovery and development of pharmaceuticals. A good part of half of those are within pharma.

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Alta Sciences

OCTOBER 30, 2023

Top 10 Life Science Resources pmjackson Mon, 10/30/2023 - 16:16 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for you. Catch up on what you may have missed below! Listen here. The Altascientist : Issue No.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2.

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Drug Discovery World

DECEMBER 18, 2023

About the author Deepika Khedekar is a Clinical Trial Lead at IQVIA, where she spearheads clinical trial monitoring programmes for major pharmaceutical companies. She holds a Master’s degree in Pharmacy from the University of Mumbai. Why 90% of clinical drug development fails and how to improve it?

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DrugBank

SEPTEMBER 26, 2024

This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles. Food and Drug Administration (FDA) have been instrumental in shaping global regulatory frameworks for biosimilars. in 2023 is projected to erode over 9.2%

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FDA Law Blog: Biosimilars

MAY 30, 2024

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. Novartis Pharmaceuticals v.

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Drug Discovery World

AUGUST 8, 2023

DDW’s Megan Thomas takes a deeper look into why India is ramping up drug discovery research, and explores the country’s innovation hubs of interest. In the global pharmaceuticals market, India ranks third worldwide for production by volume and the domestic pharmaceutical market is expected to reach US$120-130 billion by 2030 1.

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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. appeared first on Drug Discovery World (DDW).

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. 11, 2023 ( DOJ Press Release ). 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ).

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Agency IQ

JANUARY 4, 2024

Pharmacopeia (USP) defines impurities as “any component of the drug substance that is not the chemical entity that is defined as the drug substance” or, “any component of a drug product that is not the drug substance or an excipient in the drug product.” Read AgencyIQ’s analysis of the ICH guideline here ].

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Food and Drug Administration (“FDA”) approval. Food and Drug Administration (“FDA”) approval.

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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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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). The UK is now ‘on the brink’ of re-entering, according to The Guardian 5.

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Drug Discovery World

FEBRUARY 28, 2023

Read more: Rare muscular dystrophy drug to be funded in England and Wales 2. Read more: $5 million to fund trial of therapy for uveal melanoma The post Five 2023 breakthroughs in drug discovery for rare diseases appeared first on Drug Discovery World (DDW).

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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

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

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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Drug Channels

MAY 22, 2023

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new video webinar: PBMs and the Battle Over Patient Support Funds: Accumulators, Maximizers, and Alternative Funding This event will be broadcast live on Friday, June 23, 2023, from 12:00 p.m. to 1:30 p.m.

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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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Elrig

APRIL 29, 2024

Webinar | Ai At The Frontier: Empowering Early Career Professionals In Drug Discovery WEBINAR – ARE YOU CURIOUS ABOUT THE CUTTING-EDGE INTERSECTION OF ARTIFICIAL INTELLIGENCE AND DRUG DISCOVERY? Are you curious about the cutting-edge intersection of Artificial Intelligence and Drug Discovery?

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Agency IQ

JULY 12, 2024

In response to even more acute drug shortages during the Covid-19 pandemic, the European Commission issued proposals to set up a “European Health Union” meant to address drug shortages in several ways. The non-paper also suggested three potential actions to address drug shortages. medicines supply chain and its vulnerabilities.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Non-applicable drugs (e.g.,

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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 week, CDER published its guidance agenda for 2024.

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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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