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Pharmaceutical
The Hellenic Association of Pharmaceutical Companies (SFEE) said Greece’s medicines funding model is drifting further out of balance, pushing up mandatory rebates and clawback payments and, in its telling, risking poorer access to new drugs. 19 January 2026
Pharmaceutical
What started as a pan-African treaty push is now a staffed regulator with a Kigali address and early procedures already being tested. The African Medicines Agency (AMA) was adopted by the African Union in 2019 and its treaty entered into force in 2021. By 2026, 31 countries had ratified it. Rwanda hosts AMA’s headquarters in Kigali, which became operational in late 2024. 15 January 2026
Pharmaceutical
US President Donald Trump’s recent warning of a 25% tariff on countries trading with Iran introduces fresh uncertainty for India’s economic engagement with the West Asian nation. 14 January 2026
Pharmaceutical
As leaders gather in Davos, it can feel like a lifetime since three feet of distance defined daily life. Yet it was only six years ago, and the lessons of the COVID-19 pandemic remain uncomfortably relevant. Preparedness for future pandemics must embed a full range of medical countermeasures into readiness planning. 14 January 2026
Pharmaceutical
Russia will focus on more active import substitution in the domestic pharmaceutical sector, that will be part of a new healthcare development strategy, designed until 2030, which was recently approved by the national government, according to media reports. 14 January 2026
Pharmaceutical
US pharma major AbbVie has signed a voluntary agreement with the Trump administration that it says will lower prices in Medicaid while protecting its ability to invest in American drug innovation. 13 January 2026
Pharmaceutical
Swiss pharma trade body Interpharma has warned that Switzerland’s position as a global pharmaceutical hub is under strain from geopolitics and shifting pricing rules, urging rapid policy action to protect competitiveness, innovation and patient access to new medicines. 12 January 2026
Pharmaceutical
An Expert View from Steve Bulera, CVP and CSO, Discovery and Safety Assessment, Charles River. 8 January 2026
Pharmaceutical
The share of imported drugs in the Russian pharmaceutical market should significantly decline over the next six years, while most of them should be replaced by domestic drugs. 29 December 2025
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) is proposing what is calls a ground-breaking drug payment model to address the increasingly expensive cost of drugs in Medicare Part D while preserving or enhancing Medicare beneficiaries’ quality of care. 22 December 2025
Biotechnology
The US National Security Commission on Emerging Biotechnology (NSCEB) has released a new assessment of the state of the US-China biotechnology competition. 22 December 2025
Pharmaceutical
While it may have been a chaotic year for the US Food and Drug Administration (FDA) due to layoffs, leadership changes and other upheaval, the European Medicines Agency (EMA) has made significant steps forward in performing its key functions in 2025. 19 December 2025
Pharmaceutical
A wave of transformative US drug-pricing agreements and record manufacturing investments from leading biopharmaceutical companies is poised to reshape the global landscape for pharmaceutical access, production, and industrial policy, according to pharma analytics company GlobalData. 17 December 2025
Pharmaceutical
UK-based Bicycle Therapeutics, a pharma company developing a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, has entered into a 15-year contract including an option to renew with the UK Nuclear Decommissioning Authority (NDA) for access to up to 400 tonnes of reprocessed uranium (RepU). 16 December 2025
Biotechnology
New US legislation, backed by trade group Biotechnology Innovation Organization (BIO), to free up capital for small innovative firms by removing regulatory barriers for both companies and investors passed the House of Representative on December 11. 15 December 2025
Pharmaceutical
As many as four out of 10 assessments of new drugs carried out by the Danish Medicines Council had the process stopped midway in 2025, according to pharma industry group Lif. 15 December 2025
Biotechnology
M&A news last week featured Mirum Pharmaceuticals announcing plans to acquire fellow USA-based Bluejay Therapeutics and its kidney disease candidate brelovitug. The US Advisory Committee on Immunization Practices (ACIP) revealed changes to guidance on hepatitis B vaccination for newborns. On the research front, Swiss pharma giant Roche presented strong new data on its giredestrant in early breast cancer, while Rezolute released disappointing Phase III data on its congenital hyperinsulinism candidate ersodetug. 14 December 2025
Pharmaceutical
The UK government has announced that the 2026 payment rate for newer medicines under the Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) will be 14.5%, down from a record 22.5% in 2025. 10 December 2025
Generics
The US Association for Accessible Medicines (AAM) the leading trade association for generic and biosimilar manufacturers, applauds and supports The Skinny Labels, Big Savings Act, which was introduced yesterday in the US House of Representatives. 9 December 2025
Pharmaceutical
Last week the US Center for Biologics Evaluation and Research (CBER) released its plans for evaluating vaccines prompted by deaths associated with COVID-19 jabs. US drug developer Belite Bio announced positive Phase III trial results for its Stargardt disease candidate tinlarebant. Pharvaris released encouraging new Phase III data for its hereditary angioedema (HAE) investigational drug deucrictibant. Also of note, the UK and US governments sealed an agreement whereby British medicines exports to the USA will carry zero tariffs while the UK will pay higher prices for medicines. 7 December 2025
Pharmaceutical
Medicine shortages have shifted over the past two years from a problem managed in hospital pharmacies to a matter of industrial and trade policy on both sides of the Atlantic. Active shortages in the USA peaked in early 2024 and have since fallen, while Europe has built a list of critical medicines, a reporting platform and, in May 2026, a provisional deal on its Critical Medicines Act. 16 September 2026
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the European Commission's newly published proposal for a Public Procurement Act, calling it an important step towards modernizing procurement rules across the European Union (EU). 14 September 2026
Pharmaceutical
Greater government responsibility, faster access for patients and increased public investment in new medicines. A new survey from Swedish pharma trade group Lif shows broad political support for changing how medicines are financed, valued and introduced in Sweden during the next mandate. 14 September 2026
Biotechnology
Pharma industry leaders at Phacilitate Advanced Therapies Europe (ATE) 2026 have this week warned that Europe must address persistent barriers to commercialization, reimbursement, manufacturing scale-up and patient access if it is to maintain its position as a global leader in cell and gene therapy. 12 September 2026
Pharmaceutical
The Medicare Drug Price Negotiation Program is now running three cycles at once. Negotiated prices for the first ten products took effect in January 2026. A second set of 15 takes effect in January 2027. Talks on a third set of 15 close this autumn, and a fourth cycle is already in formal rulemaking. 11 September 2026
Pharmaceutical
The global pharmaceutical industry has committed an additional £2 billion ($2.70 billion) to the UK since September 2025, according to the Association of the British Pharmaceutical Industry (ABPI), which benchmarks the country against 12 leading markets on more than 40 international metrics in its 2026 competitiveness report. 8 September 2026
Pharmaceutical
Medicines Australia has released its proposed solutions to increase the number of new medicines available in Australia on the Pharmaceutical Benefits Scheme (PBS) for patients. 7 September 2026
Biotechnology
Contract development and manufacturing organization (CDMO) Northway Biotech has opened a 61 million euros ($70.8 million) Innovative Cell Therapy and Personalized Medicine Center in Vilnius, Lithuania, describing it as the first dedicated facility of its kind in the Baltic states. 4 September 2026
Pharmaceutical
America’s strong intellectual property (IP) system provides the certainty needed to invest in the risky and costly process of developing new medicines, noted trade group Pharmaceutical Research and Manufacturers of America (PhRMA) in a website posting. 3 September 2026
Pharmaceutical
The White House has announced that nine additional pharmaceutical manufacturers have signed most-favored-nation (MFN) pricing agreements with the Trump administration, bringing the total number of companies with such deals to 26, covering an estimated 89% of the US branded drug market. 1 September 2026
Pharmaceutical
The US Centers for Medicare & Medicaid Services (CMS) enforcement actions have stopped more than $1.6 billion in potentially improper Medicare laboratory payments since the start of the Trump Administration – further evidence that CMS’ efforts to crush fraud are working to protect taxpayer dollars and improve Medicare program integrity. 1 September 2026
Pharmaceutical
Sweden’s Orexo announced that the company has reached a non-binding agreement in principle on the main elements of a settlement with the US Department of Justice (DOJ). 1 September 2026
Pharmaceutical
The UK's National Institute for Health and Care Excellence (NICE) has confirmed it will adopt the EQ-5D-5L value set to measure how medicines affect patients' quality of life. 28 August 2026
Pharmaceutical
The Circle of Goodness Foundation, the Russian public fund, which specializes on the procurements of the most expensive drugs, has significantly increased its procurements this year. 26 August 2026
Pharmaceutical
The US biotech major Amgen's UK Director for Value, Access and Policy tells The Pharma Letter that closing the gap between National Institute for Health and Care Excellence (NICE) recommendation and routine patient access, not further investment alone, will determine whether the government's life sciences ambitions are realized. 25 August 2026
Pharmaceutical
The European Union's Critical Medicines Act has reached the point where its obligations can be read rather than inferred. The European Commission proposed the regulation in March 2025. The Council agreed its negotiating position on 2 December 2025, and the European Parliament adopted its own position in January 2026. 25 August 2026
Pharmaceutical
The World Health Organization's (WHO) new global framework intended to help medicines regulators transition toward greener pharmaceuticals has been welcomed by The Association Innovative Medicines (VIG), the Dutch trade body representing innovative pharma companies. 24 August 2026
Pharmaceutical
New figures from Statistics Denmark show a slowdown in Danish gross domestic product (GDP) growth and a slowing growth in exports. After a strong start to the year, economic progress has slowed down. 24 August 2026
Pharmaceutical
US President Donald Trump has nominated Heidi Overton, deputy director of the White House Domestic Policy Council, as the next commissioner of the Food and Drug Administration (FDA), announcing the choice in a social media post on Wednesday. 20 August 2026
Pharmaceutical
The Health Resources and Services Administration’s (HRSA) announcement of the revised 340B Rebate Model Pilot Program is an important step to bring greater transparency, accountability and integrity to a program that has grown in size and complexity, according to trade group Pharmaceutical Research and Manufacureres of America (PhRMA). 20 August 2026
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