FDA Law Blog

MARCH 6, 2024

Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

Pharma in Brief

APRIL 29, 2021

Among the new prohibitions was one that would prohibit a manufacturer from offering any financial assistance to patients to help cover the cost of a drug on the provincial List of Medications (Quebec’s formulary). The lowest price method also does not apply to biosimilars.

Manufacturing 52

Manufacturing Drugs Regulation Branding 52

XTalks

JUNE 8, 2022

Novartis’ biosimilars and generics drug division Sandoz has announced a new global campaign called ‘Act4Biosimilars’ to help raise awareness about biosimilars and increase their adoption by at least 30 percent in over 30 countries by the year 2030.

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Generic Pharmaceutical Production Medicine Branding 69

XTalks

JANUARY 31, 2023

The list of available medicines includes about 50 generic drugs. Prior to that, in a major move, the online retail behemoth acquired online pharmacy retailer PillPack in 2018 for around $750 million and branded it Amazon PillPack. The program also offers 24/7 assistance provided by pharmacists or support staff.

Pharmacy 52

Pharmacy Drugs Branding Generic Drugs 52

Pharma in Brief

NOVEMBER 5, 2023

Background A manufacturer can apply to have a drug product listed on Ontario’s Formulary for coverage under the Ontario Drug Benefit ( ODB ) program. For a generic or biosimilar product, the manufacturer may also apply to have the drug product designated on the Formulary as interchangeable with the original brand product.

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Drugs Regulation Production Generic Drugs 52

Delveinsight

FEBRUARY 5, 2021

Moreover, the generic drugs of Zyban are also approved, while for Chantix, its patent is soon going to expire in 2021 in the EU and in 2022 in Japan. Generics in the Market. Whenever the branded drugs go off-the-market, it paves the way for the entry of generics in the market.

Marketing 52

Marketing FDA Approval Branding Production 52

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. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. mg implant) is around $1,006.

FDA Approval 101

FDA Approval Drugs Sales Development 101

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. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. mg implant) is around $1,006.

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FDA Approval Drugs Sales Development 52

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. These medicines comprise about 10% of all generics approved each year. Still, the FDA does prioritize the review of submissions for first generics.

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Generic Drugs Branding Drugs Production 246

XTalks

SEPTEMBER 14, 2020

For example, Tailored Brands, the parent of Men’s Wearhouse and K & G, have declared they may have to file for bankruptcy protection, joining almost 7,000 other companies that filed for Chapter 11 bankruptcy protection last year. Meanwhile, the Congressional Budget office predicted that the US economy would expand at an annual rate of 12.4

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Vaccine Vaccination Antibody Life Science 92