Drug Channels

JULY 11, 2022

Informa Connect's Hub and Specialty Pharmacy Models West. September 14-15, 2022 Sheraton San Diego Hotel & Marina | San Diego, CA www.informaconnect.com/hub-specialty-pharmacy-west. Copyright © 2006-2022 Pembroke Consulting, Inc. Delivered as a Hybrid Event. Drug Channels, or any of its employees.

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Specialty Pharmacies Pharmacy Biosimilars Compliance 98

Drug Channels

MARCH 5, 2024

WHAT YOU WILL LEARN In 2023, the Inflation Reduction Act of 2022 (IRA) began to alter the Medicare Part D program and trigger changes in beneficiary out-of-pocket spending, drug prices, pharmacy economics, and market access strategies. Pharmacies and Pharmacy Benefit Managers.

Pharmacy 98

Pharmacy Biosimilars Drugs Marketing 98

Drug Channels

NOVEMBER 29, 2022

In this issue: Mark Cuban schools Elon Musk on PBMs Market access lessons from Semglee Gen Z rejects the pharmacy career path A potent call for 340B transparency Plus, get ready to love the ‘90s again! Please join me for my upcoming live video webinar, Drug Channels Outlook 2023 , on December 16, 2022, from 12:00 p.m.

Pharmacy 97

Pharmacy Drugs Marketing Biosimilars 97

Drug Channels

OCTOBER 11, 2022

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022!

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

Drug Channels

NOVEMBER 15, 2021

Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for a new live video webinar: Drug Channels Outlook 2022. The Outlook 2022 marks our third annual outlook webinar. Broadcast live on December 17, 2021. to 1:30 p.m.

Specialty Pharmacies 94

Specialty Pharmacies Biosimilars Pharmacy Drugs 94

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ). 2, 2020 ( DOJ Press Release ).

Pharmacy 52

Pharmacy Regulations Production Laboratories 52

Drug Channels

OCTOBER 17, 2022

December 12-14, 2022 in Philadelphia, PA www.informaconnect.com/trade. Don’t miss Informa Connect's Trade & Channel Strategies Summit , coming up December 12-14, 2022 in Philadelphia! Drug Channels readers will save 10% off when they use code 22DRCH10 and register prior to November 11, 2022.*.

Biosimilars 75

Biosimilars Pharmacy Therapies Production 75

Drug Channels

OCTOBER 10, 2023

Drug Distribution Industry Gaining from Anti-Obesity Drugs and Provider-Administered Biosimilars (press release) We’re offering special discounted pricing if you order before October 20, 2023! reviews the evolving specialty pharmacy industry and discusses emerging challenges from direct distribution models that bypass wholesale distribution.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

Drug Discovery World

MARCH 29, 2023

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. According to EFPIA, RDP protects an innovator’s investment by granting a limited period of exclusivity on the data it generated, starting from marketing authorisation 4.

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Clinical Trials Biosimilars Pharma Companies Production 130

FDA Law Blog: Biosimilars

MAY 13, 2024

Extolling RWE, FDA has said “RWE can be leveraged to bring new products to market, evaluate the safety and effectiveness of existing products for new uses, and assess the continued performance and safety of products once on the market.” Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.

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FDA Production Trials Pharmacy 111

FDA Law Blog: Biosimilars

APRIL 8, 2024

FDA previously analyzed 163 drugs that went into shortage in the 5-year period between 2013 and 2017; 63% (103) were sterile injectables and 67% (109) were drugs that have a generic version on the market. of the White Paper states, accurately, that “factors that cause drug shortages are multi-faceted and involve many market participants.”

Drugs 59

Drugs FDA Hospitals Government 59

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. had Part D expenditures on or before August 16, 2022).

Compliance 105

Compliance Pharmacy Drugs Licensing 105

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. Priority A List.

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FDA Science Biosimilars Production 40

Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. AgencyIQ October 1 Nitrosamine testing due to FDA.

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA 40

FDA Science Regulations Production 40

FDA Law Blog: Biosimilars

JUNE 2, 2023

For 10 high-cost single source covered outpatient drugs selected annually by CMS, manufacturers would be required to respond to a so-called “price verification survey” by providing not only clinical and utilization information about the drug, but also costs of production, distribution, research, and marketing; revenue and profit; and ex-U.S.

Drugs 59

Drugs Regulations Government Vaccine 59

Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

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FDA Science Regulations Production 40