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EMA publishes EU strategy to 2028

European Pharmaceutical Review

A draft joint EU network strategy to 2028 has been published by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). The overarching theme of our updated strategy to 2028 is that of change – rapid, somewhat unpredictable but nonetheless full of promise.

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Moderna’s Covid-19 vaccine sales forecast slashed amidst strong competition

Pharmaceutical Technology

Despite this, Spikevax’s average annual sales forecast has plummeted by 23% between H1 and H2 2022 according to GlobalData’s Coronavirus Disease 2019 (COVID-19) Sector Forecast reports, due to increasing competition from Pfizer’s Comirnaty, Novavax’s Nuvaxovid, and Covid-19 therapeutics.

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Pharma’s reputational high will be short-lived

World of DTC Marketing

Pharma has gone to court again and again to delay generic competition of biologic drugs. One company AbbVie has used the courts to stop competition of its top drug Humira. Another biologic, Enbrel, on the market since 1998, will not have its $5 billion in sales challenged until the end of 2028.

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Top biopharmaceutical Covid-19 vaccine companies boosted with over 80% revenue growth

Pharmaceutical Technology

According to GlobalData’s report, Paxlovid, the company’s small-molecule Covid-19 oral therapy, was shown to reduce Covid-19 infections by 32% in adults and is forecast to be the top-selling drug by total sales, generating $81bn between 2021 and 2028. AbbVie reported a 22.7% Bristol Myers Squibb (BMS) documented a 9.1%

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The EU AI Act: will regulation drive life science innovation away from Europe?

European Pharmaceutical Review

Without sufficient support systems and experienced reviewers, the implementation timelines were extended, with final compliance dates now pushed to December 2028 (from May 2024 originally). This situation raises concerns that similar delays could impact the EU AI Act, creating uncertainty for companies relying on clear, consistent timelines.

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EU tax compliance proposals to streamline business investment

European Pharmaceutical Review

Ultimately, this puts European businesses at a competitive disadvantage compared to other companies worldwide. Once adopted by the Council, the regulatory proposals are planned to come into force on 1 July 2028 (for BEFIT) and on 1 January 2026 (for the transfer pricing proposal).

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Amgen splashes out on ChemoCentryx and its blockbuster hopeful

pharmaphorum

The deal comes as Amgen has been under pressure from competition to its big-selling arthritis therapy Enbrel (etanercept) and blood cell booster Epogen (epoetin alfa), and a patent expiry for psoriasis blockbuster Otezla (apremilast) in 2028.