FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

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XTalks

FEBRUARY 8, 2021

In order to fact-check some of these misconceptions, the US Food and Drug Administration (FDA) recently hosted a webinar on biosimilar and interchangeable biological products to help healthcare professionals understand more about these treatment options. Biosimilars are the “generic” drugs of the biopharma world.

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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FDA Law Blog

SEPTEMBER 6, 2021

Typically, generic sponsors carve out a patent-protected indication or patient population, but technically, any method of use can be carved out as long as FDA determines that the product can still be used safely and effectively without the patent-protected information. The catch is, as we have learned from the GSK v. “In

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. The company is comprised of several units, and the largest is Johnson & Johnson’s pharma unit which generated $52.56 billion in pharmaceutical sales from 2021. billion the drug generated in 2021. billion, a 42.74

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The Pharma Data

JANUARY 17, 2021

The Company will continue to leverage its scientific expertise and operations in Europe and North America for product development and optimization while it plans to add significant commercial experience in the fields of manufacturing, distribution, marketing and sales. SOURCE: XPhyto Therapeutics Corp.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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XTalks

FEBRUARY 5, 2024

In the dynamic landscape of oncology therapeutics, understanding the trends and performances of leading drugs is crucial for stakeholders across the healthcare and life sciences sectors. The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research.

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Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. Food and Drugs Act , R.S.C.,

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Pharma in Brief

JUNE 21, 2020

On June 19, 2020, the Patented Medicine Prices Review Board ( PMPRB ) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. Amendments to the Patented Medicines Regulations are scheduled to come into force on January 1, 2021. Background. New patented medicines.

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The Pharma Data

JANUARY 27, 2021

Since its inception, Vektor has worked for major and emerging drug companies to develop new and generic dosage formulations based on its sublingual and transdermal drug delivery platforms. Further, Vektor is currently engaged in the development of a sublingual drug formulation for a major European generic drug company.

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The Pharma Data

MAY 4, 2021

Following the completion of the spin-off of the Upjohn Business (4) in the fourth quarter of 2020, Pfizer now operates as a focused innovative biopharmaceutical company engaged in the discovery, development, manufacturing, marketing, sales and distribution of biopharmaceutical products worldwide. Cost of Sales (1). previously $59.4

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The Pharma Data

MAY 7, 2021

Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales ( STAT ). US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ). International regulators and WHO call for wider public access to clinical data ( EMA ). Generic Drug Cos.

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Pharma in Brief

FEBRUARY 8, 2024

On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product ( CRP ) in the Food and Drug Regulations ( Regulations ). For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.

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The Pharma Data

OCTOBER 14, 2020

Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients. To learn more about Mallinckrodt , visit www.mallinckrodt.com. and foreign tax laws or the impact of disputes with governmental tax authorities; and the impact of Irish laws.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Pharmacy Checkers

DECEMBER 26, 2019

To pick a drug strength and quantity, researchers recorded the first result in a search on www.pharmacychecker.com. sales prices. viii] “FDA’s Drug Importation Data is Wrong,” PharmacyChecker News Release, July 17, 2018. ix] “The Public Health Role of Drug Regulation in the US,” a presentation by Douglas C.

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XTalks

SEPTEMBER 14, 2020

If retail sales were the sole indicator that the US economy is recovering, the country would have something to cheer about. According to the Commerce Department, retail sales rose 7.5 Retail sales in the UK have bounced back to relatively high levels, even though initially, sales were extremely anemic, with only a 0.9

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Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. for drug safety. counterparts. J)(2) Waiver authority.

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