FDA Law Blog: Biosimilars

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. Final Guidance at 2.

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pharmaphorum

JANUARY 13, 2023

Everyone agrees that cell and gene therapies are poised for an explosion, with far more drugs in the pipeline than are currently approved, and the FDA predicts it will clear 10 to 20 per year by 2025. “We need to fix this fast, or else there is going to be more legislation that is going to target us.

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Pharma in Brief

JANUARY 10, 2024

Expected highlights for 2024 include a final PTA regime, more details on PMPRB drug pricing guidelines and national pharmacare, and fall-out from the US mass drug importation program targeting Canadian medicines. The amendments are scheduled to come into force no later than January 1, 2025. Rare disease strategy.

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Pharmaceutical Technology

JULY 21, 2022

Pharma giant AstraZeneca also plans to make its supply chain carbon-negative by 2030; to reduce its Scope 1 emissions by 20%, Scope 2 emissions by 95%, and Scope 3 emissions by 25% per $1m of sales by 2025. According to the World Health Organization (WHO), two billion people lack access to essential or basic drugs.

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Express Pharma

FEBRUARY 10, 2025

India trends: The power of AI and data analytics is ushering generative AI, along with AI and ML, into the Indian biopharma industry, contributing to areas such as disease understanding and vaccine development. It will continue to be a trend in 2025. There’s two ways.

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European Pharmaceutical Review

FEBRUARY 20, 2025

The American Hospital Association has warned that increased costs and delays in sourcing critical drugs could lead to shortages of essential medicines, including antibiotics, oncology treatments, and cardiovascular drugs. Generic drug manufacturers, which operate on slim profit margins, are likely to be most affected.

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Express Pharma

JANUARY 30, 2025

anti-vaccine stance. per cent decline in market capitalisation in 2024, following its acquisition of Vifor Pharma in August 2022, aimed at diversifying its portfolio of vaccines and blood plasma products. Kennedy Jr.s However, three companies achieved growth greater than 10 per cent: Lilly (32.4 per cent), AbbVie (14.8

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