Biosimilars, Pharmacy and Therapies - Drug Discovery Digest

The Competitive Edge of Biosimilars

DrugBank

SEPTEMBER 26, 2024

Biosimilars Biosimilars, while highly similar to their reference biopharmaceuticals, offer distinct advantages that position them as preferred therapeutic options in many cases. This is because biosimilars are not new drugs but highly similar versions of already approved therapies with established safety and efficacy profiles.

Informa Connect's Hub and Specialty Pharmacy Models West

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. Delivered as a Hybrid Event. Drug Channels readers will save 10% off the current registration rate when they use code 22DC10 *.

Specialty Pharmacies

Specialty Pharmacies Pharmacy Biosimilars Compliance

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

Pharmacy

Pharmacy Government Treatment Compliance

The Evolution of Medical Benefit Contracting: How Pharma Can Prepare

Drug Channels

JANUARY 27, 2023

Saket discusses market access and contracting strategies for medical benefit products when pharmacy benefit biosimilar therapies launch. Today’s guest post comes from Saket Patel, Consultant, Advisory Services at MMIT. He then describes how to automate formulary and medical policies to protect manufacturers from overpayment.

Drug Channels News Roundup, November 2020: Rebate Rule Redux, MFN (maybe), Amazon’s Pharmacy Customers, Drug Spending, GPO M&A, and RxTrace

Drug Channels

NOVEMBER 24, 2020

In this issue: Rebate rule redux Most Favored Nation and healthcare benchmarking Amazon’s pharmacy customer opportunity Drug spending realities updated GPO consolidation Plus, I congratulate Dirk Rodgers of RxTrace on his retirement. P.S. Join the more than 10,600 followers of my curated links published on @DrugChannels on Twitter.

Pharmacy

Pharmacy Specialty Pharmacies Biosimilars Doctors

Informa Connect’s Trade & Channel Strategies Summit

Drug Channels

OCTOBER 17, 2022

Don’t miss the chance to unite with colleagues and master the complexities of pharmacy and distribution models to accelerate patient access!

thINc’s Specialty Networks and Patient Support Services Summit

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.

Specialty Pharmacies

Specialty Pharmacies Pharmacy Biosimilars Compliance

Informa Connect’s Health Systems & Pharma Partnering Summit

Drug Channels

JUNE 26, 2023

View the agenda for Health Systems & Pharma Partnering 2023 to see the complete picture – the program, speakers, and more, and visit www.informaconnect.com/health-systems-partnering for further details and to register.

Biosimilars

Biosimilars Pharmacy Science Therapies

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science

Science Biosimilars FDA Production

Six Crucial Trends Facing U.S. Drug Wholesalers

Drug Channels

DECEMBER 1, 2020

Pharmacy and healthcare provider markets experienced unprecedented volatility. During 2020, the COVID-19 pandemic disrupted every aspect of the pharmaceutical channel—and our lives. If all goes well, 2021 will begin our return to normalcy, as vaccines roll out across the country. This year has demonstrated the underlying resilience of U.S.

Pharmacy

Pharmacy Vaccine Drugs Pharmaceuticals

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

FDA

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

FDA Science Regulations Production

DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

FDA Law Blog: Biosimilars

JUNE 23, 2024

However, the well-intentioned statutory language enacted in 1970 did not anticipate important changes in clinical therapies and advances in medical technology, and in some cases has created obstacles both to ensuring needed patient access and successful medical outcomes. 2] Why is this an issue? Highly concentrated opioid formulations (e.g.,

Nurses

Nurses Therapies Regulations Pharmacy

Drug Discovery Digest

The Competitive Edge of Biosimilars

Informa Connect's Hub and Specialty Pharmacy Models West

Trending Sources

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

The Evolution of Medical Benefit Contracting: How Pharma Can Prepare

Drug Channels News Roundup, November 2020: Rebate Rule Redux, MFN (maybe), Amazon’s Pharmacy Customers, Drug Spending, GPO M&A, and RxTrace

Informa Connect’s Trade & Channel Strategies Summit

thINc’s Specialty Networks and Patient Support Services Summit

Informa Connect’s Health Systems & Pharma Partnering Summit

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Six Crucial Trends Facing U.S. Drug Wholesalers

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Top Ten most popular articles on Pharmafile.com this week

DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

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