Drug Channels

MARCH 18, 2024

Informa Connect’s Life Sciences Pricing & Contracting USA May 21-23, 2024 | New Orleans Drug Channels readers save 10% with code 24DRCH10* Whether your daily focus is on Medicaid, Government Pricing, 340B, Drug Price Transparency, Commercial Contracting or Chargebacks , we have you covered!

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Science Government Regulations Drugs 98

Drug Channels

FEBRUARY 21, 2023

On March 14, 2023, Drug Channels Institute will release The 2023 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. we highlight potential implications of the IRA for the drug channel. Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. In Subsection 12.5.1.,

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Pharmacy Specialty Pharmacies Licensing Licensing 97

Drug Channels

DECEMBER 17, 2021

This week, I’m rerunning some popular posts while I prepare for today's live video webinar: Drug Channels Outlook 2022. This tale neatly summarizes why so many people hate our healthcare system—and why the average patient will have trouble benefiting from transparency regulations. d/b/a Drug Channels Institute. See you soon!

Hospitals 75

Hospitals Regulations Drugs 75

Drug Channels

FEBRUARY 22, 2022

On March 15, 2022, Drug Channels Institute will release The 2022 Economic Report on U.S. drug pricing, reimbursement, and dispensing system. We also present a more unified outlook for specialty drugs, including specialty generics and biosimilars. Copyright © 2006-2022 Pembroke Consulting, Inc.

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Pharmacy Specialty Pharmacies Biosimilars Licensing 96

Drug Channels

SEPTEMBER 15, 2021

This tale neatly summarizes why so many people hate our healthcare system—and why the average patient will have trouble benefiting from transparency regulations. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc.

Hospitals 75

Hospitals Regulations Marketing Drugs 75

Drug Channels

OCTOBER 6, 2020

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. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Biosimilars Marketing Regulations FDA 52

Drug Channels

JANUARY 22, 2021

He introduces us to the Wolters Kluwer drug data solutions. These solutions promote interoperability and help healthcare businesses meet regulations related to health information exchange. Read more » Copyright © 2006-2021 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. d/b/a Drug Channels Institute.

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Drug Channels

AUGUST 18, 2020

The enormous profit opportunities from the 340B Drug Pricing Program offer further encouragement for hospitals. Manufacturers would be wise to incorporate hospitals into channel strategy planning for their specialty drugs. Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. d/b/a Drug Channels Institute.

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Specialty Pharmacies Pharmacy Hospitals Regulations 52

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 latest data show that provider-administered biosimilar drugs are successfully displacing their reference biological products.

Biosimilars 52

Biosimilars Marketing Regulations FDA 52

FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Laboratories FDA Regulations Licensing 81

Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well.

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Drug Channels

AUGUST 21, 2020

As regular readers know, I believe the 340B Drug Pricing Program needs to evolve into a more transparent, properly regulated program. Regards, Adam Read more » Copyright © 2006-2020 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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Compliance Regulations Drugs 52

Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite. Drug Channels, or any of its employees.

Pharmacy 75

Pharmacy Biosimilars Marketing Production 75

Drug Channels

AUGUST 9, 2021

Informa Connect’s Medicaid Drug Rebate Program — MDRP 2021 Hybrid. View the complete agenda , then register for the All Access Pass (in-person + virtual) or Virtual-Only Pass using the exclusive Drug Channels discount code 21MDRP10 to receive 10% off! Drug Channels, or any of its employees. d/b/a Drug Channels Institute.

Government 40

Government Drugs Regulations Therapies 40

Advarra

DECEMBER 1, 2022

In the past several years, Health and Human Services (HHS) Office of Human Research Protections (OHRP), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) have announced and/or implemented new regulations to address the challenges of conducting clinical trials involving multiple research sites.

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Regulations Compliance FDA Clinical Trials 52

Drug Channels

OCTOBER 30, 2023

Drug Channels, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@drugchannels.net). Copyright © 2006-2023 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

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Pharmaceutical Companies Regulations Pharmaceuticals Drugs 74

Drug Channels

JULY 17, 2023

Drug Channels readers will save 10% off when they use code 23DRCH10 and register prior to August 11, 2023.* Drug Channels readers will save 10% off when they use code 23DRCH10 and register prior to August 11, 2023.* * Cannot be combined with other offers or used towards a current registration. Drug Channels, or any of its employees.

Drugs 40

Drugs Government Regulations Science 40

Advarra

MARCH 19, 2024

The Food and Drug Administration’s (FDA’s) February 2024 draft guidance Use of Data Monitoring Committees in Clinical Trials signals a significant shift in approach. In its latest DMC draft guidance, the agency introduces several noteworthy updates and clarifications to its 2006 guidance.

Clinical Trials 52

Clinical Trials Trials FDA Regulations 52

FDA Law Blog: Biosimilars

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).

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FDA Laboratories Regulations Compliance 59

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

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Research FDA Approval Drugs FDA 52

Advarra

NOVEMBER 10, 2022

On September 28, 2022, the Food and Drug Administration (FDA) released two Notices of Proposed Rulemaking (NPRM). In addition to the harmonization goal, these additional elements help modernize the regulations with current scientific and participant expectations. . Again, this is similar to what HHS regulations currently permit. .

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Regulations FDA Research Trials 52

Drug Channels

NOVEMBER 30, 2020

With drug pricing and benefit coverage top of mind for many Americans, coupled with a volatile election and overall healthcare landscape, the stakes are incredibly high for bio/pharma manufacturers. Staying on the pulse of industry trends, policies and changing regulations has never been more crucial. d/b/a Drug Channels Institute.

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Government Pharma Companies Regulations Drugs 52

Drug Channels

SEPTEMBER 16, 2024

Informa Connect's Patient Support Services Congress November 20-21, 2024 | Hilton Penn’s Landing, Philadelphia, PA Drug Channels readers save 10%* with code 24DC10. Drug Channels subscribers — Save 10% off the current registration rate with promo code 24DC10*. Register today. All rights reserved.

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Compliance Regulations Pharmaceuticals Drugs 52

Drug Channels

OCTOBER 12, 2020

Informa Connect-CBI’s 6th Edition Drug Pricing Transparency Congress. November 16-17, 2020 | Virtual Event www.informaconnect.com/drug-pricing-transparency. Drug Channels Readers: View the complete agenda and register today. Drug Channels, or any of its employees. Copyright © 2006-2020 Pembroke Consulting, Inc.

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Compliance Drugs International Regulations 40

Drug Target Review

JUNE 6, 2023

This suppressive mechanism involves a negative regulator – a protein called IL-18BP or IL-18 binding protein, that works as a “decoy receptor” by binding to IL-18 and preventing it from binding to its functional receptor. American Association for Cancer Research; 2006 [cited 2023 Jun 6]. Available from: [link]

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Engineering Immune Response Biochemical Pharmacology Clinical Trials 98

Drug Channels

SEPTEMBER 3, 2024

The content of Sponsored Posts does not necessarily reflect the views of HMP Omnimedia, LLC, Drug Channels Institute, its parent company, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@DrugChannels.net). All rights reserved.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceuticals Government Regulations 52

National Institute on Drug Abuse: Nora's Blog

JULY 22, 2024

Volkow, National Institute on Drug Abuse Image ©Getty images/ seb_ra Over the past several years, the increasing prevalence of fentanyl in the drug supply has created an unprecedented overdose death rate and other devastating consequences. in that period. with mainstream medicine.

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Pharmacy Treatment Community Pharmacies Trials 78

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). Specifically, FDA is looking to remove a drug called carbadox from the market. Used for over 50 years, carbadox is an antimicrobial drug used to treat gastrointestinal disease in pigs.

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FDA FDA Approval International Production 59

Common Sense for Drug Policy Blog

JANUARY 5, 2024

Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. It was only when its use grew further, and more evidence about its addictive potential came to light, that the United States finally passed the 1974 Drug Control Act (Rawson et al. As Crary ( 2013 , p. Chemical 24/7.

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Pharmacy Regulations Production Marketing 52

Drug Target Review

FEBRUARY 28, 2024

These include engineering the cells to express cytokines that promote their maturation and/or differentiation, and engineering drug-resistant γδ T cells that can be combined with chemotherapies, which stress cancer cells but would otherwise also deplete the T-cell population. Regulation of cutaneous malignancy by gammadelta T cells.

Therapies 105

Therapies Engineering Molecular Biology Science 105

Drug Channels

DECEMBER 19, 2022

Drug Channels, or any of its employees. To find out how you can promote an event on Drug Channels, please contact Paula Fein (paula@drugchannels.net). Copyright © 2006-2022 Pembroke Consulting, Inc. d/b/a Drug Channels Institute. Drug Channels® is a registered trademark of Pembroke Consulting, Inc.

Regulations 52

Regulations Science Pharmaceuticals Drugs 52

The Pharma Data

MAY 12, 2021

When the Pediatric Regulation (EC No. 1901/2006) came into effect in 2007, the goal was to create an environment where pediatric medicines could be researched and made available without “studies on children or delaying authorization for adults.” Here, “the submission of PIPs is a binary item,” he said. .

Compliance 52

Compliance Regulations Clinical Trials Trials 52

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Broadly, the rule sought to require the use of certain safeguards in the production, storage, and use of medical gases.

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FDA Regulations Production Packaging 40

Advarra

DECEMBER 15, 2022

Policies and Regulations Affecting Single IRB Review. Health and Human Services (HHS) regulations as much as practicable, which includes sIRB requirements. This requirement entered the regulations as part of a broader update in 2017, commonly referred to as the Revised Common Rule. This proposal is intended to require all U.S.

Clinical Trials 52

Clinical Trials Regulations FDA Trials 52

Advarra

FEBRUARY 24, 2023

Sometimes, it can be as simple to determine as comparing drug A to placebo and measuring the physiological result with an approved assay. How do you strategically plan your therapy and research objectives to improve the chances you will satisfy what the regulators are looking for and ultimately get your therapy approved for marketing?

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Clinical Trials Trials FDA Therapies 52

The Premier Consulting Blog

DECEMBER 28, 2023

Under section §812.10, a sponsor may request a waiver of any requirement of the IDE regulations through an application with supporting documentation. The FDA may grant a waiver if the requirement is not stipulated by the Federal Food, Drug, and Cosmetic (FD&C Act) or if it is not necessary for the protection of human subjects. [3]

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FDA FDA Approval Regulations Compliance 52

Drug Channels

SEPTEMBER 29, 2020

Exclusive Offer for Drug Channels Readers – View the complete agenda and register today – Be sure to use your exclusive promo code USAVE3 to save $300 *. As managing copay programs continues to be significantly more complex, it is imperative to stay on top of current trends, emerging regulations and future legislation.

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