Drug Channels

SEPTEMBER 13, 2021

Informa Connect’s Drug Pricing Transparency Congress. Delivered as a Hybrid Event In-Person: November 9-10 | Philadelphia, PA Virtual: November 16-17 www.informaconnect.com/drug-pricing-transparency. Exclusive Offer for Drug Channels Readers: Use Promo Code 21DPT10 to Receive 10% off Your Registration.

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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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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!

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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.

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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 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.

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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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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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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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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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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.

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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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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.

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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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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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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.

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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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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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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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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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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.

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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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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. .

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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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Agency IQ

JANUARY 12, 2024

BY WALKER LIVINGSTON, ESQ | JAN 8, 2024 9:33 PM CST TSCA and PFAS The Environmental Protection Agency (EPA) implements the Toxic Substances Control Act (TSCA), which provides the basis for much of the chemical regulation in the United States. statues such as pesticides, cosmetics, drugs, food, and food additives, among others.

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Drug Channels

AUGUST 14, 2021

Benefit from crucial and timely updates addressing access challenges and exploring the impact of copay accumulators, maximizers and drug pricing legislation on patient affordability. Analyze State and Federal Progress Regulating Copay Programs DOJ Updates:?Government Drug Channels, or any of its employees.

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FDA Law Blog: Drug Discovery

MARCH 7, 2024

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. One notable change in the new draft guidance is the language regarding when a DMC is recommended, reflecting the much broader adoption of DMCs since 2006.

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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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Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

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The Pharma Data

SEPTEMBER 9, 2020

Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. Additional applications are under review with numerous regulators, including in the EU and China. ENSPRYNG has been designated as an orphan drug in the U.S., ENSPRYNG has been designated as an orphan drug in the U.S.,

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The Pharma Data

JANUARY 18, 2021

OKYO has previously announced that it anticipates making an investigational new drug submission with the US Food and Drug Administration for the use of chemerin in the treatment of DED. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. Gary S. .

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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.

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The Pharma Data

AUGUST 16, 2020

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved ENSPRYNG (satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

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New Drug Approvals

JANUARY 9, 2024

2006 Mar 1; 20(5):601-12, 2006), in contrast with CDK9, which phosphorylates both Ser-2 and Ser-5 of the CTD heptad (Pinhero et al., In addition to CDK7, other CDKs have been reported to phosphorylate and regulate RNA pol (II) CTD. 1004-1014, 2004). Oct 1 5;24(20):2303-16, 2010; Blazek et al., Konig et al., Cancer Res.

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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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Agency IQ

JUNE 7, 2024

The devil is in the details: a deep dive into the state of Notified Body designations While the European Commission has been laser-focused on the number of medical device and IVD certificates, AgencyIQ is taking a look at progress toward designating Notified Bodies to the European medical device and diagnostics regulations.

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Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

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