Drug Channels

APRIL 8, 2024

We intend to bring together people from the entire drug channel: pharmaceutical manufacturers, pharmacy benefit managers (PBMs), health plans, insurers, and plan sponsors, wholesalers and distributors, pharmacies, providers, buying groups, government officials, and more. We will also have a very limited number of sponsors.

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Fierce BioTech

MARCH 29, 2024

Is your pharmacy ready to make the leap? Learn how your pharmacy can prepare today for a future of pharmacy focused on patient outcomes. On Demand Start Date Wed, 05/15/2024 - 15:00 Related Categories Pharma Manufacturing

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Drug Channels

DECEMBER 13, 2023

This week, I’m rerunning some popular posts while I prepare for Fiday's Drug Channels Outlook 2024 live video webinar. For 2023, specialty pharmacies—via white, brown, and clear bagging—retained a meaningful share of the distribution channels for provider-administered oncology drugs. d/b/a Drug Channels Institute.

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National Drug & Alcohol Research Centre Blog

DECEMBER 4, 2023

In Australia, both methadone and buprenorphine have been subsidised by the Pharmaceutical Benefit Scheme (PBS) for the treatment of opioid dependence (termed ‘opioid agonist treatment’ or OAT) for several decades. The use of opioid agonist treatment increased in non-community pharmacy settings from early 2020. Chidwick, K., Farrell, M.,

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Drug Channels

OCTOBER 1, 2024

This week, I’m rerunning some popular posts while we put the finishing touches on DCI’s new 2024-25 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. Last week, the Federal Trade Commission (FTC) released the redacted version of administrative complaint against the three largest pharmacy benefit managers (PBMs).

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Fierce BioTech

JANUARY 19, 2024

The Cardinal Health™ Sonexus™ Access and Patient Support team will explore innovative ways to create efficiencies and improve the patient experience with AI-powered patient access backed by best-in-class pharmacy and operations. On Demand Start Date Wed, 03/06/2024 - 15:00 Listing Image CardinalHealth-Logo-Listing-1022023.png

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Drug Target Review

MARCH 12, 2024

Scientists from the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California San Diego have discovered thousands of bile acids. The team debuted a novel tool to instantly match microbes to the metabolites they produce earlier in 2024. 2023 February 5 [2024 March 11]; 15(1). Gut Microbes.

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Fierce BioTech

DECEMBER 27, 2023

This will allow pharmaceutical companies to reach consumers directly, to reduce costs, increase efficiency, provide patients with faster access to medications, improve adherence, and create a more personalized experience. Discover the value of a white-labeled pharmacy from a marketing messaging and operational perspective.

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The Pharma Data

OCTOBER 27, 2021

GSK Consumer Healthcare today unveils a three-year programme to support the pharmacy profession with additional practical resources, mental health provisions and proposed policy changes as part of its new report Standing with Pharmacists in the Age of Self-Care.

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Broad Institute

JUNE 11, 2024

#WhyIScience Q&A: A biochemist uses mass spectrometry to find proteins involved in cancer By Corie Lok June 11, 2024 Breadcrumb Home #WhyIScience Q&A: A biochemist uses mass spectrometry to find proteins involved in cancer Moe Haines talks about how his open-minded approach to science led him to pursue a career in proteomics.

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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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FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

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Drug Discovery World

AUGUST 8, 2023

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. To many, the country is referred to as the ‘pharmacy of the world’. So, what is driving this success, and will it continue?

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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. With nearly 479,000 trials 6 registered globally as of early 2024, we are facing an outright data avalanche. Accessed Jan 2024. Accessed Feb 2024. Accessed Feb 2024. Accessed Feb 2024. Accessed Jan 2024.

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Agency IQ

JANUARY 4, 2024

BY AMANDA CONTI, CHELSEY MCINTYRE, PHARMD | JAN 3, 2024 5:44 PM CST Background: Benzene impurities The U.S. To help control impurities, the FDA requires all starting materials used in drug manufacturing and final pharmaceutical products to be evaluated for “identity, strength, quality and purity.”

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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. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

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Drug Discovery World

JULY 27, 2023

As reported by the BMJ, Sunak, introducing the Windsor framework at a press conference on 27 February, said, “From now on, drugs approved for use by the UK’s medicines regulator will be automatically available in every pharmacy and hospital in Northern Ireland.”

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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. Pharmaceutical companies asked the FDA to use this opportunity to rethink how much risk information is appropriate for an ad.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

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Agency IQ

JULY 12, 2024

BY KIRSTEN MESSMER, PHD, RAC | JUL 10, 2024 11:16 PM CDT Background on medicines shortages and recent policy making regarding medicines shortages Medicines shortages have been identified as a major health concern in Europe for many years now. active pharmaceutical ingredient, fill/finish, packaging/labeling). points of disruption).

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Agency IQ

MARCH 25, 2024

BY CHELSEY MCINTYRE, PHARMD | MAR 20, 2024 10:32 PM CDT Background: Drug compounding in the U.S. Products compounded by 503A pharmacies are specifically exempt from needing to adhere to Current Good Manufacturing Practice (cGMP) requirements, labeling regulations and new drug approval requirements. What is drug compounding?

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Agency IQ

JANUARY 26, 2024

BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA? Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.”

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Common Sense for Drug Policy Blog

FEBRUARY 20, 2024

13 , 37 A recent study reported benefits of accessing pharmaceutical alternatives, including increased agency regarding how participants consumed their drugs and when they chose to attend the clinic. dwf_admin Tue, 02/20/2024 - 11:25 Source Geoff Bardwell, Andrew Ivsins, Manal Mansoor, Seonaid Nolan, Thomas Kerr.

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Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The rule, will also, if finalized, address communication with State boards of pharmacy. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Elrig

APRIL 29, 2024

I pursued a degree in Pharmacy from the University of Murcia to become a qualified Pharmacist, followed by an MSc in Cancer Pharmacology at London Metropolitan University. Joining Isomorphic Labs in October 2024, I’m thrilled to be part of their mission to revolutionize DD through AI/ML.

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Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The report must be published within 120 days of each new fiscal year.

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Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Codon

FEBRUARY 13, 2024

3 Another considerable obstacle to pharmaceutical companies’ interest (and investment) is the fact that for a product to be patentable — and therefore profitable — it has to be considered new and inventive. Phage therapies are sold at a pharmacy in Georgia. Asimov Press (2024). Cite this essay: Tom Ireland.

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). That meant both the pharmacist and the pharmacy where the vaccine was administered “covered persons” under the act. Forest Pharmaceuticals, Inc. Pacira Pharmaceuticals, Inc. 4th 851 (6th Cir.

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