Pharmaceutical Market Europe • Ocber 2025 • 8-10
NEWS
Pfizer agrees pricing and distribution deal with US government
Pfizer has finalised an agreement with the US government that will make a broad range of its medicines available in the US at discounted prices via a federal direct-purchasing platform. The agreement also serves to secure temporary relief for the company from forthcoming US tariffs.
While the full terms of the arrangement remain confidential, Pfizer confirmed that the move is a voluntary response to US President Donald Trump’s 31 July letter to pharma companies urging lower prices for US patients.
Under the agreement, Pfizer has committed to aligning US drug prices more closely with international markets and to ensuring price parity for newly launched products. Pfizer is the first big pharma company to reach a formal arrangement with the US government following the letter.
Medicines covered under the agreement will be listed on the government’s direct-to-consumer purchasing site, TrumpRx.gov. The majority of primary care treatments and certain specialty products are expected to be offered at an average 50% discount compared with current prices, while some reductions could be as high as 85%.
EU medicine shortages hit record highs in 2023 and 2024
A new report from the European Court of Auditors (ECA) has found that medicine shortages across the EU reached record levels over the past two years. Although measures have been introduced to address the issue, auditors warn that delays in implementation could leave the region exposed to further disruption.
Medicine shortages can affect both innovative and off-patent products, and can become critical when no suitable alternatives are available. In such cases, coordinated EU-level action is required. According to the ECA, shortages peaked in 2023 and 2024, with 136 medicines being categorised as being in critical shortage between January 2022 and October 2024.
Supply chain vulnerabilities have been highlighted by the European Commission as a driver of shortages. Heavy reliance on outsourced production in Asia, particularly for antibiotics and painkillers, leaves EU supply susceptible to regional and global trade disruptions. Additional risks arise from stockpiling and the lack of cross-border coordination on critical medicine availability.
Several initiatives have been introduced to mitigate these risks, including incentives for localised production and the launch of the EU’s first common list of critical medicines.
AstraZeneca announces agreement with US government to reduce medicine costs
AstraZeneca has announced an agreement with the US government aimed at lowering the cost of prescription medicines for US patients and expanding the company’s domestic manufacturing footprint.
The announcement follows a meeting between AstraZeneca CEO Pascal Soriot, the US President and members of the US government. The company confirmed it has voluntarily met all requests outlined in the President’s 31 July letter to the healthcare and pharmaceutical sectors, which called for reduced medicine costs.
Under the terms of the agreement, AstraZeneca will launch direct-to-consumer sales programmes targeting eligible patients with prescriptions for chronic diseases. Selected medicines will be offered at discounts of up to 80% less than list prices. The company will also make certain medicines available at reduced cash prices via the government’s TrumpRx.gov direct purchasing platform.
AstraZeneca also reached an agreement with the US Department of Commerce to delay Section 232 tariffs for three years. The extension will enable the company to complete its plans to onshore medicines manufacturing within the US.
Earlier this year, AstraZeneca announced a $50bn investment in its US manufacturing and R&D infrastructure. The company already has 19 manufacturing, R&D and commercial sites in the US.
Lilly to invest $5bn in US manufacturing facility
Eli Lilly has announced that it plans to build a $5bn manufacturing facility in Virginia, US. The planned Virginia facility is part of the company’s $50bn capital expansion commitments in the US since 2020.
The new site will be the company’s first dedicated, fully integrated active pharmaceutical ingredient (API) and drug product facility for Lilly’s emerging bioconjugate platform and monoclonal antibody portfolio.
Earlier this year, Lilly announced plans to bolster its domestic medicine production across therapeutic areas by building a total of four new pharmaceutical manufacturing sites in the US.
The new site in Virginia will develop active pharmaceutical ingredients for cancer, autoimmune and other advanced therapies, and is expected to be completed within the next five years.
To maximize the latest technology, digital integrations and automation, the company plans to engage locally, partnering with local universities and supporting community educational initiatives in Virginia.
The company plans to announce the three remaining US manufacturing sites this year and expects to start production at these four facilities within the next five years.
AstraZeneca to invest $4.5bn in US manufacturing facility
AstraZeneca has announced the next phase of its $50bn investment programme to strengthen its US manufacturing network, with plans for a new $4.5bn facility in Virginia.
The site was initially designed to produce drug substances for AstraZeneca’s weight management and metabolic disease portfolio, including oral GLP-1, baxdrostat, oral PCSK9 and combination small-molecule therapies.
The expanded investment – an additional $500m beyond the original commitment – will broaden the site’s remit to include antibody-drug conjugate (ADC) manufacturing, supporting AstraZeneca’s growing oncology pipeline.
The facility is expected to become operational within five years and will significantly enhance the company’s US-based manufacturing capacity. Around 600 high-skilled roles will be created in Virginia, including positions for engineers, scientists and process facilitators. The expansion is also projected to generate a further 3,000 jobs during the development and construction phases.
Pascal Soriot, CEO, AstraZeneca, said: “With our $4.5bn investment in Virginia, the largest in AstraZeneca’s history, we are not only building a state-of-the-art manufacturing facility, but also driving life sciences innovation and economic growth.”
Amgen commits $650m to US manufacturing expansion
Amgen has announced a $650m expansion of its US manufacturing network, focused on its Juncos, Puerto Rico site. The investment is expected to create around 750 jobs, spanning construction roles and long-term, highly-skilled manufacturing positions.
The expansion will enhance biologics production capacity and introduce new technologies across the Juncos facility. While specific applications have not yet been disclosed, the company indicated the upgrades will strengthen resilience across its global supply chain.
“This expansion underscores Amgen’s commitment to US biomanufacturing and strengthening the resilience of our global supply chain,” said Robert A Bradway, chairman and chief executive officer at Amgen.
The announcement builds on Amgen’s ongoing investment in its US operations. Since 2017, following the introduction of the Tax Cuts and Jobs Act, the company has invested more than $40bn in domestic manufacturing and R&D.
Recent projects include a $600m science and innovation centre in California, a $900m manufacturing expansion in Ohio and a $1bn manufacturing expansion in North Carolina.
“By growing our capacity to deliver innovative medicines with cutting edge technology in our manufacturing plants, we will not only better serve patients but also create high-quality jobs,” Bradway added.
Lilly and WHO Foundation partner to support global dementia action plan
Eli Lilly and the WHO Foundation have partnered to support the World Health Organization’s (WHO) global action plan on the public response to dementia.
Established in 2020, the WHO Foundation is an independent organisation that mobilises philanthropic investment and fosters collaborations between public and private sectors to address global health challenges and advance health equity. Under the new agreement, Lilly will provide financial support to the Foundation to strengthen the implementation of the WHO’s dementia strategy.
Dementia is the seventh leading cause of death globally and a major contributor to disability and dependency among older adults. As of 2021, an estimated 57 million people worldwide were living with dementia, with more than 60% residing in low- and middle-income countries.
Member States at the United Nations General Assembly on the prevention and control of non-communicable diseases and the promotion of mental health and well-being have recognised dementia and Alzheimer’s disease – the most common form of dementia – as public health priorities.
Key priorities of the partnership include enhancing risk reduction strategies, improving early detection and diagnosis, and raising standards of care.
MHRA marks 100 years of patient safety through biological standards
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has marked the centenary of the first biological standard being introduced on World Standards Day.
Biological standards provide scientific benchmarks that ensure medicine development and manufacturing are consistent across different companies and countries.
These standards were first introduced in the early 20th century to regulate diphtheria treatments, where variability in antitoxin potency between manufacturers posed significant safety risks. The first international biological standard, established in 1925 for insulin, ensured consistent treatment for people with diabetes.
Today, scientists at the MHRA’s science campus prepare and distribute more than 95% of the biological standards endorsed by the World Health Organization (WHO). Between October 2024 and September 2025, the agency supplied over 100,000 ampoules or vials to 1,500 organisations across 81 countries.
The MHRA also contributes to the development of biological standards for emerging therapies, such as monoclonal antibodies and cell and gene therapies. The agency currently provides more than 450 WHO standards used to develop and evaluate biological medicines, ensuring accurate and reproducible results. Similarly, the British Pharmacopoeia – a division of the MHRA – sets legally binding quality standards for medicines used by the NHS, guiding safe and reliable administration.
MHRA and FDA expand collaboration on AI and medtech regulation
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced plans to deepen its collaboration with the US Food and Drug Administration (FDA) to enhance patient access to innovative medical technologies.
MHRA chief executive Lawrence Tallon outlined joint initiatives between the two agencies during a fireside chat with Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, at the Advanced Medical Technology Association (AdvaMed) conference in San Diego, US.
Among the key developments is a move towards greater regulatory alignment between the two agencies. Under the MHRA’s proposed new framework, international reliance routes will be introduced, allowing medical devices approved by trusted overseas regulators to gain faster and more efficient access to the UK market.
While initially focused on products authorised by the FDA, the MHRA confirmed that these routes could later extend to devices approved by regulators in Australia, Canada and other comparable markets.
The UK’s new medical technology regulations are expected to come into force in 2026, with the reliance routes anticipated to launch the following year.
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