Drug Channels

MAY 29, 2024

Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Register now for The 340B Drug Pricing Program: Trends, Controversies, and Outlook , a new live video webinar with Adam J. Click here to learn more and reserve your spot at the June 21 event. All rights reserved.

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

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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Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year.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. We have tried to sort guidance documents by topic area.

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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. and national regulators.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 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. and national regulators.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

The FIE determination released in fall 2023 involves the Reference Product AbbVie’s Humira (adalimumab) and two interchangeable biosimilars—first approved is Cyltezo (adalimumab-adbm), filed by Boehringer Ingelheim Pharmaceuticals, Inc, which was followed by Abrilada (adalimumab-afzb), filed by Pfizer.

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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. and national regulators.

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Agency IQ

MARCH 29, 2024

What we expect European regulators to do in April 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. and national regulators.

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FDA Law Blog: Biosimilars

JUNE 30, 2024

RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at improving the medical device commercialization landscape.

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Drug Discovery World

FEBRUARY 20, 2024

billion in 2024 to $6.06 The new report says the anticipated growth to 2028 will be fuelled by the expansion of precision medicine, advancements in drug-drug interaction prediction, analysis of patient-derived data, development of biosimilars, and the increasing number of drug candidates.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

AUGUST 24, 2023

HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®. Hyman, Phelps & McNamara, P.C. (“HP&M”) Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA Law), Sara W. Koblitz (FDA Law), Allyson B.

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Fierce BioTech

MARCH 28, 2024

dfarris Thu, 03/28/2024 - 15:39 Early involvement of Medical Affairs in advanced therapies is pivotal. Rare Disease Therapeutics biosimilars drug manufacturing Resource Type Whitepaper Eversana-250x190.png png Thu, 03/28/2024 - 16:00 Pharma Drug Delivery Manufacturing Pharma Landing Page Url [link] Byline Sponsored by: Eversana

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Drug Channels

FEBRUARY 21, 2024

Just another IRA-inflicted hit for biosimilars? Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. Below, I explain why the IRA will encourage Part D plans to prefer high-list, high-rebate specialty drugs , even as the government and manufacturers will prefer a low-list-price version.

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Drug Channels

MARCH 5, 2024

Fein, president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s latest live video webinar: Drug Channel Implications of the Inflation Reduction Act This event will be broadcast live on Friday, April 5, 2024, from 12:00 p.m. This event is part of The Drug Channels 2024 Video Webinar Series.

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FDA Law Blog: Biosimilars

DECEMBER 21, 2023

Both are celebrating their 75th anniversaries in 2024. 2024 brings a host of Hyman, Phelps & McNamara, P.C. 2024 brings a host of Hyman, Phelps & McNamara, P.C. (“HPM”) In other exciting news — in 2024 FDLI will be getting a make-over! What do Gene Autry’s Rudolph the Red-Nosed Reindeer and FDLI have in common?

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FDA Law Blog: Biosimilars

MARCH 19, 2024

Fellow HPM Director Jeff Gibbs to Speak at the 2024 AMDM Annual IVD Regulatory Meeting HP&M Director Jeff Gibbs will present at the 2024 AMDM Annual IVD Regulatory Meeting held in Bethesda, MD on April 24-25, 2024, at the Bethesda North Marriott. Mr. Gibbs’ presentation, entitled “U.S.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

(HP&M) proudly announces that Director Anne Walsh will be a featured panelist at the highly anticipated 2024 Women’s White Collar Defense Association (WWCDA®) Leadership Retreat and Annual Attorney Meeting. The event is set to take place from March 4-6, 2024, in San Francisco, California.

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Drug Discovery World

FEBRUARY 22, 2024

Regeneron’s market capitalisation growth was attributed to the FDA approval of its high-dose Eylea – a VEGF fusion protein – for eye diseases, which may likely offset standard Eylea’s expected sales decline following looming biosimilar competition.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

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FDA Law Blog: Drug Discovery

DECEMBER 20, 2023

At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings. This will apply to all meeting requests received on January 22, 2024, or later. In June 2023, the list expanded to include Type B End-of-Phase 2 meetings (which we blogged about here ).

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Agency IQ

JANUARY 19, 2024

BY KIRSTEN MESSMER, PHD, RAC | JAN 17, 2024 9:16 PM CST Quick background: EMA annual new medicines reports At the beginning of each calendar year, the EMA publishes a New Medicines Highlights report, providing a high-level overview of new medicines reviewed by the EMA’s Committee for Medicinal Products of Human Use (CHMP).

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FDA Law Blog: Biosimilars

JULY 1, 2024

Karst — The Drug Enforcement Administration (“DEA”) has received more than 2 7 ,000 public comments in response to its May 21, 2024 , Notice of Proposed Rulemaking (“ NPRM ”) to reschedule marijuana from schedule I to schedule III. Letter to DEA Administrator Anne Milgram, from Peter Bensinger, et al., ( June 19, 2024 ).

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Drug Channels

JUNE 5, 2023

Join peers this August to discover the evolving specialty pharmacy marketplace, build multi-stakeholder partnerships, and explore frameworks to inform your 2024 distribution and patient service strategies.

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The Pharma Data

JULY 28, 2021

Combining its strength in generic medicines and knowledge of specialty drugs, Teva is developing its pipeline and portfolio to increase access to affordable medicines, including through the development of biosimilars—highly similar less-costly versions of the reference branded biologic drugs, which are made from living cells or organisms.

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Agency IQ

DECEMBER 1, 2023

This effort will most likely be set up in early Q1 of 2024. This December look-ahead includes all activities that we anticipate will occur through January 1, 2024. Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U.

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FDA Law Blog: Biosimilars

JUNE 12, 2024

FDA seemingly dismissed most of these concerns, and, the Report notes, “[a]s of February 2024, FDA did not have any plans to revise its OTC hearing aid regulations. FDA does, however, expect to issue a report on OTC hearing aid adverse events to Congress by August 2024.

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FDA Law Blog: Biosimilars

JUNE 10, 2024

DEA, Palomar Hospital Pays $250,000 for Diverting Fentanyl ( June 3, 2024 ). DOJ, Iowa Surgical Center Agrees to Pay $125,000 to Resolve Allegations It Violated the Controlled Substances Act ( June 4, 2024 ). Employee diversion can result in unwanted local and national publicity.

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FDA Law Blog: Biosimilars

AUGUST 7, 2023

By Véronique Li, Senior Medical Device Regulation Expert — The Center for Devices and Radiological Health (CDRH) offers learning opportunities for new and experienced CDRH staff through the Experiential Learning Program (ELP).

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FDA Law Blog: Biosimilars

MAY 15, 2024

On April 29, the FDA issued their long-awaited, controversial Final Rule governing the oversight of laboratory developed tests ( LDTs ). This new rule will dramatically alter the LDT regulatory landscape, while at the same time requiring significant operational changes and posing strategic challenges for many LDTs.

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Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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Agency IQ

MARCH 1, 2024

In November, Congress passed a short-term CR that extended some federal funding (at current levels) through March 1, 2024. Notably, this explanation of what “excepted staff” does is different in both version of the 2024 contingency plan than what appeared in the 2023 contingency plan. What is happening now?

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount.

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FDA Law Blog: Biosimilars

JUNE 10, 2024

Director Larry Houck will participate as a panelist focusing on this timely topic in the Food and Drug Law Institute’s (“FDLI’s”) “High Time for a Change: Implications of DEA’s Proposed Marijuana Rescheduling” webinar June 12, 2024, 2:00-3:30 pm ET.

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Agency IQ

SEPTEMBER 15, 2023

While fees payable for OTC Monograph Order Request (OMOR) submissions have previously been published in March, six months after the start of the fiscal year, the fees are now being published prior to the start of the 2024 fiscal year. This likely means that industry will have to wait until March 2024 for facility fee information.

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