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
Biotechnology
Privately-held US firms Tahoe Therapeutics and Alloy Therapeutics are to form a jointly seeded new company focused on developing first-in-class antibody-drug conjugates (ADCs) for hard-to-treat cancers. 15 January 2026
Pharmaceutical
The US Food and Drug Administration yesterday approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease in pediatric patients. The FDA approved Zycubo, previously known as CUTX-101, for Sentynl Therapeutic, a part India’s Zydus Lifesciences which filed the regulatory filing and is partnered with Fortress Biotech.
. 14 January 2026
Pharmaceutical
The Biotechnology Innovation Organization criticized changes to the US childhood immunization schedule, saying the move lacks a scientific basis and could put children’s health at risk. 13 January 2026
Biotechnology
US pharma major AbbVie and China’s RemeGen today announced an exclusive licensing agreement for the development, manufacturing and commercialization of RC148, a novel investigational programmed cell death-1 (PD-1)/V7 vascular endothelial growth Factor (VEGF)-targeted bispecific antibody. 12 January 2026
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A privately held biotechnology platform company based in the Boston, Massachusetts area. It operates as a partner-facing “ecosystem” business supporting biologics discovery and development across multiple modalities, and it also participates in company creation through its venture studio model.
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Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis’ ianalumab for Sjögren’s disease, the second most prevalent rheumatic autoimmune disease, the Swiss pharma giant announced late Friday. 17 January 2026
Pharmaceutical
Japanese drugmakers Mochida Pharmaceutical and Marubeni Pharmaceutical announced that Mochida has obtained new drug approval from the China National Medical Products Administration (NMPA) for Epadel S900 (MND-21). 17 January 2026
Biotechnology
Shares of Danish biotech Genmab fell as much as 5% on Friday, after is released disappointing top-line clinical results for its Epkinly (epcoritamab), which is partnered with US major AbbVie. 17 January 2026
Biotechnology
Sweden’s Sobi has announced that the European Commission (EC) has approved Aspaveli (pegcetacoplan) for adults and adolescents aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated or contraindicated. 16 January 2026
Biotechnology
WuXi XDC has made a bid to buy fellow Chinese firm BioDlink, a fully integrated CDMO offering end-to-end biologics development and manufacturing services. 16 January 2026
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Pharmaceutical
16 January 2026 French pharma major Sanofi is preparing an offer to acquire the US biopharmaceutical firm Ocular Therapeutix, according to a report by French publication La Lettre.
Pharmaceutical
15 January 2026 Swiss pharma company Santhera Pharmaceuticals announced that the Swiss Agency for Therapeutic Products (Swissmedic), has approved Agamree (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.
Conferences
12 January 2026 15 January 2026 California, USA, The Westin St. Francis
30 August 2026 2 September 2026 Montreal, Canada, Montréal Congress Center
28 August 2026 31 August 2026 Munich, Germany, Munich Trade Fair Centre
25 August 2026 27 August 2026 Seoul, South Korea, COEX Convention & Exhibition Center
10 August 2026 12 August 2026 Pennsylvania, USA, Loews Philadelphia Hotel
6 August 2026 8 August 2026 DC, USA, Walter E. Washington Convention Center
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Pharmaceutical
An Expert View from Steve Bulera, CVP and CSO, Discovery and Safety Assessment, Charles River. 8 January 2026
Pharmaceutical
The holiday period typically thins out formal decisions, but several regulators still published material updates spanning approvals, policy consultations, and authorization summaries. 5 January 2026
Pharmaceutical
With 2025's pharma M&A spend exceeding $150 billion—going by deals reported on by The Pharma Letter—the total was higher than the sum spent in both 2024 and 2023. 30 December 2025
Pharmaceutical
The US Food and Drug Administration (FDA) spent much of 2025 in the spotlight. Through steady drug approvals, renewed emphasis on transparency, and concrete steps to modernize its operations, the FDA’s actions this year helped shape expectations for 2026. 30 December 2025
Pharmaceutical
The Russian antitrust regulator – the Federal Antimonopoly Service (FAS) seems to be losing its legal battles with domestic pharmaceutical companies that launched their generics in the market prior to expiration of patents for original drugs, The Pharma Letter’s local correspondent reorts. 30 December 2025
Pharmaceutical
Latin America will need to overhaul how it budgets and finances healthcare if it is to strengthen health systems by 2026 and improve access, quality and efficiency, particularly for patients with chronic and noncommunicable diseases (NCDs), according to a new regional study. 29 December 2025
Biosimilars
This month, Samsung Bioepis announced the European launch of Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. 29 December 2025
One to Watch Companies
One to watch
A privately-held French biotech advancing a clinical pipeline of gamma delta T-cell-focused antibodies for cancer and autoimmune diseases.
One to watch
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.
One to watch
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.
One to watch
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.
Boardroom
Generics
Effective January1, 2026, STADA Arzneimitel’s global head of communications, Frank Staud, is additionally assuming global responsibility for STADA’s global government affairs, the German generics and consumer healthcare major announced today. 16 January 2026
Pharmaceutical
US biologics CDMO Avid Bioservices has appointed Rich McAvoy as chief business officer, as the company talks up “disciplined execution” and on-time delivery in a market where sponsors have little patience for manufacturing surprises. 16 January 2026
Pharmaceutical
Minnesota, USA-based contract development and manufacturing organization (CDMO) and drug delivery innovator Kindeva today announced a series of planned leadership transitions designed to position the company for accelerating growth in its core businesses focused on parenteral and inhaled drug delivery. 15 January 2026
Pharmaceutical
US pharma major Bristol Myers Squibb has announced the appointment of Harald Hampel as senior vice president, worldwide head of medical affairs, Neuroscience. 14 January 2026
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