Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

Biosimilars 130

Biosimilars Drug Pricing Compounding Drug Development 130

Pharmaceutical Technology

SEPTEMBER 15, 2022

However, the FDA's approval of Lumakras for metastatic non-small cell lung cancer in May last year has a global analyst consensus sales forecast of $336m for this year, according to GlobalData’s Drugs Database. BioNTech (18,644.5%) and Moderna (1,842.3%) had more than 100% YoY operating income growth last year due to Covid-19 vaccine demand.

Vaccines 108

Vaccines Drug Pricing Biosimilars Documentation 108

Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

Biosimilars 100

Biosimilars Drug Pricing Compounding Drug Development 100

European Pharmaceutical Review

JANUARY 18, 2024

Insomnia market Dual orexin receptor antagonists (DORAs) [dual orexin receptor antagonists (DORAs)]… offer a new mechanism of action [in treating insomnia]” Across the seven major markets, the insomnia market is anticipated to grow at a compound annual growth rate (CAGR) of 2.6 percent from $3.2 billion in 2022 to $4.1

Drug Pricing 98

Drug Pricing Biosimilars Compounding 98

European Pharmaceutical Review

JUNE 24, 2022

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. It is too early to say because we have not seen the whole package of measures yet.

Compounding 105

Compounding Drug Development Drug Pricing Dosage 105

pharmaphorum

AUGUST 27, 2020

Regulatory pressures, lengthy drug development times, and the fact that drug prices have become politicised have raised risks and cut revenue projections, leading to the biotech sector falling out of fashion.

Vaccines 122

Vaccines Drug Pricing Compounding Immunity 122

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. The primary manufacturer of a selected drug may also request CMS to terminate its agreement if they are unwilling to participate in the Medicare Drug Price Negotiation.

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

Ramblings of a pharmacist

FEBRUARY 16, 2022

For example, “In the compounding period of 1941, the average pharmacy filled about 5,000 prescriptions a year, approximately 15 a day.” Each choice has bearing on the final result that Drug Channels calls out - “IQVIA data show that for 2020, the GDR for unbranded generics in the overall market was 88.5%.

Independent Pharmacies 52

Independent Pharmacies Compounding Specialty Pharmacies Prescription Filling 52

pharmaphorum

FEBRUARY 18, 2021

Drug prices to plummet in wave of expiring patents”. Price decay after loss of brand exclusivity”. These are just three headlines that come up when you Google “drug patent expiry”. Eli Lilly’s Humalog compound and formulation patents expired in 2013 and 2014, respectively. “Patent losses could sink Allergan”.

Prescription Filling 52

Prescription Filling Drug Pricing Biosimilars Compounding 52

pharmaphorum

JUNE 2, 2022

While in 2021, orphan drugs made up over half of all the US FDA’s approvals, with the figures in European being similarly high – 19 out of 54 approved new active substances. The report estimates that the orphan drug market will grow twice as fast as the non-orphan market, with a 2021 to 2026 compound annual growth rate of 12%.

Compounding 52

Compounding Pharmaceutical Companies Pharmaceutical Companies Drug Pricing 52

Proxsys Rx

DECEMBER 11, 2023

Given that, why would a drug company want to reimburse the price of a 340B-covered specialty drug costing tens of thousands of dollars, if the provider isn’t dispensing it correctly and the patient doesn’t benefit?

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Labelling 52

STAT

AUGUST 15, 2024

… Medicare unveiled the results of the program’s first 10 drug price negotiations and estimated that if the prices for all of the medicines had been in effect in 2023, the U.S. Lilly and Novo previously sued more than three dozen spas, clinics, and compounding pharmacies. And of course, do keep in touch.

Compounding 265

Compounding Compounding Pharmacies Drug Pricing 265

Proxsys Rx

MARCH 1, 2024

Given that, why would a drug company want to reimburse the price of a 340B-covered specialty drug costing tens of thousands of dollars, if the provider isn’t dispensing it correctly and the patient doesn’t benefit?

Specialty Pharmacies 40

Specialty Pharmacies Hospitals Drug Pricing Labelling 40

STAT

MARCH 7, 2025

Today, we unpack Marty Makary’s Senate  confirmation hearing, see a new ruling against GLP-1 compounders, examine the effects of the NIH patent freeze, and explore the tumultuous biotech job market.   Sign up  to get our biotech newsletter in your inbox. Read the rest…

Compounding 250

Compounding Drug Pricing Drug Development 250

STAT

DECEMBER 18, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Good morning, my colleagues were diligently roaming the halls of Congress yesterday, talking to senators about their thoughts on RFK Jr. Read on to hear what the lawmakers said. Read the rest…

Compounding 248

Compounding Drug Pricing Drug Development 248

STAT

FEBRUARY 20, 2025

” In particular, they pointed to counterfeiters, online retailers selling active ingredients without requiring a prescription, and some compound pharmacies that “cut corners” in preparing custom-made versions of the drugs. Read the rest…

Compounding Pharmacies 288

Compounding Pharmacies Compounding Drug Pricing 288

STAT

JANUARY 6, 2025

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Today, we have a new biotech scorecard, which lays out the next quarter’s worth of the sector’s expected stock-moving events.

Compounding 281

Compounding Drug Pricing Drug Development 281

Drug Patent Watch

DECEMBER 18, 2024

Each stage of drug development can potentially yield patentable inventions. From initial compound discovery to formulation improvements, every step offers opportunities for patent protection.” Balancing Profit and Public Health Pharmaceutical companies face increasing scrutiny over drug pricing and access.

Drug Development 98

Drug Development Compounding Dosage Pharmaceutical Companies 98

Drug Patent Watch

DECEMBER 19, 2024

Let’s explore the key components: Active Pharmaceutical Ingredients (APIs) Patents on APIs are the foundation of any drug patent portfolio. These protect the core molecule or compound that gives a drug its therapeutic effect. Q: What role does patent portfolio management play in drug pricing?

Pharmaceutical Companies 92

Pharmaceutical Companies Pharmaceutical Companies Dosage Drug Pricing 92

Ramblings of a pharmacist

FEBRUARY 20, 2022

At the same time, we see our neighbors complain about rising drug prices, and the rising cost of health insurance: Restaurateurs complain a lot about GrubHub and their seller fees, their menu stealing, and their ghost kitchens. We complain about DIR fees. About financial middlemen who add no value but extract plenty.

Health and Personal Care Stores 40

Health and Personal Care Stores Independent Pharmacies Drug Pricing Packaging 40

Pharma Marketing Network

JUNE 8, 2020

Well the power of compound interest, you know, created a very different scenario. I think both the two major parties in the United States are really taking aim at pharma and telling them you’ve got to reduce prices. I’d like you to touch base on this a little bit of the film that you were crowdsourcing.

Health and Personal Care Stores 40

Health and Personal Care Stores Hospitals Mayo Clinic Specialty Pharmacies 40

STAT

MARCH 11, 2025

The Pharmaceutical Research and Manufacturers of America led a delegation of executives to the White House last month to ask Trump for changes to a Biden-era law that allows the government to negotiate certain drug prices.

Compounding 237

Compounding Drug Pricing 237