FDA Law Blog: Biosimilars

MARCH 12, 2025

Raimondo Exploring the On-Sale Bar and Applicability of Prior Art Orange Book Delisting Attempts Navigating ODP and Patent Family Dynamics Hyman, Phelps & McNamara, P.C.s

Drug Pricing 59

Drug Pricing 59

FDA Law Blog: Biosimilars

MARCH 18, 2025

Even though the PTE provisions established in the Drug Price Competition and Patent Restoration Act are forty-plus years old, courts are still grappling with questions about how to best implement the Patent Term Extension.

Drug Pricing 59

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 59

Definitive Healthcare

FEBRUARY 23, 2024

Resource Type E-Books & How-To Guides Blog How-To Guide Healthcare Insight Medical claims 101: What you need to know How to sell effectively to healthcare facilities and executives using the right… Hospital payor mix by state Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pauseOnHover":false,"pauseOnDotsHover":false,"autoplay":false,"rows":0},"sm":{"slidesToS

Drug Pricing 52

Drug Pricing Hospitals Drug Development 52

Integra X Files

APRIL 3, 2023

Regulatory Landscape Prior to 1984, generic drugs were required to undergo the same level of scrutiny as the drugs they were intended to substitute. In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act, more commonly known as the Hatch Waxman Act.

Biosimilars 78

Biosimilars Drug Pricing 78

Pharma Leaders

JUNE 1, 2023

It makes sense of everything successful drug and device manufacturers must know and do, delivering the news, analysis and interpretation of industry changes you need to stay in compliance and thrive.

Drug Pricing 40

Drug Pricing Documentation 40

European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book. September 10, 2021.

Biosimilars 96

Biosimilars Dosage Drug Pricing Pharmaceutical Companies 96

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S.

Dosage 59

Dosage Drug Pricing 59

STAT

JULY 5, 2024

Or maybe read a book. … A new observational study reported for the first time a potential link between Novo Nordisk’s GLP-1 drugs Ozempic and Wegovy and an eye condition that can cause vision loss , STAT tells us. This is a lovely time to enjoy the great outdoors, but choose carefully if crowds are not your thing.

Diabetes 294

Diabetes Drug Pricing 294

Pharmaceutical Technology

JANUARY 6, 2023

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

STAT

MARCH 18, 2025

Some booked stays at a nearby Comfort Inn in order to avoid a six-hour round-trip commute. In conversations with U.S. Some are signaling a willingness to expand manufacturing in the U.S., while pressing for tax breaks and regulatory changes that would make it easier to make that happen. At the main campus in Silver Spring, Md.,

Drug Pricing 191

Drug Pricing 191

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

You said prices not costs, could you elaborate a little bit more on that and what the difference is for our listeners? Dave (HR): Yeah, I actually have a chapter in my book on this. You’ve written a book about the opioid crisis. Don (PMN): Sure, if we could, I want to drill down a little bit on something that you said.

Health and Personal Care Stores 40

Health and Personal Care Stores Hospitals Mayo Clinic Specialty Pharmacies 40

STAT

OCTOBER 18, 2024

Or you could hide indoors with a good book. drug prices and repeal the Affordable Care Act, leaving something of a vacuum in his health policy agenda. One drug prices to a basket of payments made by similarly wealthy countries, but has retreated from that approach. Well, whatever you do, have a grand time.

Drug Pricing 265

Drug Pricing Pharmaceutical Companies Pharmaceutical Companies 265