The US Federal Trade Commission has hailed what it calls a ‘landmark settlement’ with one of the nation’s largest pharmacy benefit managers (PBMs), Express Scripts, and its affiliated entities. 5 February 2026
The US Department of Health and Human Services (HHS) has sharply expanded its use of artificial intelligence, listing around 450 AI use cases across the department in a newly published fiscal 2025 inventory. 4 February 2026
US genomics specialist Illumina has completed its acquisition of proteomics company SomaLogic, adding large-scale protein analysis to its multiomics portfolio and strengthening its push beyond sequencing into faster drug discovery and biomedical research. 2 February 2026
Health Canada has authorized Livmarli (maralixibat) oral solution and tablet formulation for the treatment of cholestatic pruritus in patients aged 12 months or older with progressive familial intrahepatic cholestasis (PFIC), Mirum Pharmaceuticals announced on Friday. 7 February 2026
Swiss pharma giant Novartis on Friday revealed it has broken ground on a new, state-of-the-art global Biomedical Research center in San Diego, California, USA, designed to provide world-class scientific infrastructure and drug-discovery capabilities to advance the company’s pipeline for patients. 7 February 2026
US biotech Eikon Therapeutics has raised about $381 million in the largest biotech IPO of the year so far, but the market’s first reaction was cautious. Shares fell nearly 17% on their first day of trading, closing at $15. 6 February 2026
Chinese biotech Kelun-Biotech has won a new approval from China’s National Medical Products Administration for sac-TMT (sacituzumab tirumotecan), a TROP2-directed antibody-drug conjugate. 6 February 2026
Pfizer today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review for the company’s supplemental Biologics License Application (sBLA) for Hympavzi (marstacimab) to expand the approved indication to include the treatment of hemophilia A or B patients 6 years and older with inhibitors, and pediatric patients (ages 6 to 11) with hemophilia A or B without inhibitors. 6 February 2026
2 February 2026 French pharma major Sanofi has breached the Association of the British Pharmaceutical Industry (ABPI) Code of Practice for the Pharmaceutical Industry and brought discredit upon, and reduced confidence in, the pharmaceutical industry.
27 January 2026 The US Department of Health and Human Services (HHS) has ended the permitted use of human fetal tissue from elective abortion in agency-funded research, applying the policy across all grants, contracts, and programs it oversees.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has spent the past decade trying to make the country a more attractive place to develop and launch innovative drugs and biologics. The most visible signal is the Sakigake designation program, which offers priority consultation and a faster review target for eligible products, plus policy incentives that can support earlier market entry. 2 February 2026
On January 6, 2025, the US Food and Drug Administration (FDA) issued draft guidance titled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products.” The guidance outlines the FDA’s expectations for the use of AI in supporting regulatory assessments of safety, effectiveness, and quality. 2 February 2026
The India-European Union (EU) Free Trade Agreement (FTA) represents a significant opportunity for India's pharmaceutical sector, opening doors to a $572.3 billion market while reinforcing India's global healthcare leadership, reports The Pharma Letter’s India correspondent. 2 February 2026
It is becoming evident that German oncology start-up CatalYm has a highly promising asset on its hands in the shape of visugromab, a first-in-class anti-growth differentiation factor-15 (GDF-15) antibody. 29 January 2026
Study startup, and specifically, feasibility, site selection and activation, remains one of the most critical yet challenging early phases of clinical trial delivery. Despite technological and operational advances, startup can often be a bottleneck, resulting in delaying the point at which the first participant can be enrolled. These delays can have significant consequences for trial momentum and overall timelines. 26 January 2026
Ossama Anter Abo Arab, chief executive of MultiCare Egypt for Pharmaceutical Industries, talks with The Pharma Letter about pharmaceutical growth in Egypt. 26 January 2026
In an industry where many companies claim to be reinventing the wheel, it is rare to find one that is truly doing something different—and winning recognition from big pharma for doing so. 26 January 2026
MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases.
Privately-held GAIA is focused on the development of evidence-based, safe and accessible AI-powered digital therapeutics (DTx) that help patients restore and maintain their mental and physical health.
Exsilio Therapeutics is developing genomic medicines that can be delivered in lipid nanoparticles to durably and safely treat a broad range of diseases, including genetic diseases, cancer, and autoimmune conditions.
Privately-held San Diego biotech ADARx Pharmaceuticals announced the appointment of Dr Donald Fong as chief medical officer (CMO) to lead the advancement of its clinical-stage pipeline. 6 February 2026
California-based Braveheart Bio, a biotech developing next-generation therapeutics for hypertrophic cardiomyopathy (HCM) and related cardiovascular conditions, has announced that Marc Evanchik has been promoted to chief scientific officer (CSO). 5 February 2026
Danish pharma major Novo Nordisk said on Tuesday it had appointed Jamey Millar head of its US business, and Hong Chow head of product and portfolio strategy. 5 February 2026
UK biotech Levicept, which is focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), today announced the appointment of James Sandy as chief development officer (CDO). 4 February 2026