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Pharmaceutical
15 January 2026 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.
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Biotechnology
Madrigal Pharmaceuticals last week expanded its portfolio with the acquisition of ervogastat from Pfizer, and AbbVie inked a licensing with China’s RemeGen for the bispecific antibody RC148, in a deal worth a potential $5 billion. On the research front, Johnson & Johnson posted new data on its Tecvayli for the treatment of multiple myeloma, and Denmark’s Genmab released mixed results for its blood cancer drug Epkinly (epcoritamab). 18 January 2026
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
Pharmaceutical
Russian customers are forced to save on drug purchases these days due to the ever-growing prices, falling incomes, and the overall deterioration of business environment in the country. 16 January 2026
Biotechnology
Italian non-profit organization Fondazione Telethon today announced the European Commission’s decision of January 9, to grant marketing authorization for Waskyra (etuvetidigene autotemcel), an ex vivo gene therapy for the treatment of Wiskott-Aldrich syndrome (WAS), a rare and severe genetic immunodeficiency. 16 January 2026
Pharmaceutical
As many as four decisions under the US Food and Drug Administration’s (FDA) new fast-track program have been delayed, Reuters has reported. 16 January 2026
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
Biotechnology
Indian drug major Sun Pharmaceutical Industries yesterday announced that Unloxcyt (cosibelimab-ipdl) is now available in the USA for healthcare professionals to prescribe for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. 16 January 2026
Pharmaceutical
DelveInsight says the US hemophagocytic lymphohistiocytosis (HLH) market was worth about $140 million in 2024, reflecting a small but high-need patient population and outcomes that remain challenging even with aggressive care. 16 January 2026
Pharmaceutical
President Donald Trump on Thursday unveiled what the White House calls the “Great Healthcare Plan,” an affordability-first package that he says would lower prescription drug prices and insurance premiums, while increasing transparency in the health system. 16 January 2026
Pharmaceutical
Japanese drugmaker Tanabe Pharma said its oral candidate dersimelagon met the primary endpoint and showed a favorable safety profile in INSPIRE, a global Phase III trial in erythropoietic protoporphyria and X-linked protoporphyria, two ultra-rare disorders marked by painful reactions to light. 16 January 2026
Biotechnology
Japan’s Eisai has reached a license agreement with Nuvation Bio, a global oncology company focused on tackling some of the toughest challenges in cancer treatment, that significantly expands the long-term global footprint of Ibtrozi (taletrectinib) in the USA and Japan.. 16 January 2026
Pharmaceutical
iiDiagnostics (iiDX), a company formed by the Infection Innovation Consortium, and Canadian biotech Eyam Health have launched a collaboration to bring forward Eyam Health’s novel vaccine technology using advanced automated organoid models. 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
Tech giant Nvidia and pharma major Eli Lilly have announced a first-of-its-kind AI co-innovation lab focused on applying AI to tackle some of the most enduring challenges in the pharmaceutical industry. 15 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
All news
Pharmaceutical
Japanese drug developer Renalys Pharma yesterday announced positive top-line results from its Phase III clinical study of sparsentan (development code: RE-021), an orally administered dual endothelin and angiotensin II receptor antagonist (DEARA), in Japanese patients with IgA nephropathy (IgAN). 27 November 2025
Pharmaceutical
The global market for intratumoral cancer therapies is set for a long growth runway, according to new sector analysis from DataM Intelligence, outlining rising clinical use of oncolytic viruses, adenoviral vectors, and localized immunomodulators. 27 November 2025
Pharmaceutical
Danish drugmaker Novo Nordisk has asked the US Food and Drug Administration regulator to assess a stronger 7.2 mg version of its obesity drug Wegovy (semaglutide) under the Commissioner's national priority voucher scheme, potentially clearing the way for a rapid decision. The filing targets adults needing chronic weight-management support. 27 November 2025
Biotechnology
US biotech Lunai Bioworks has signed its first letter of intent to license its off-the-shelf immune cell therapy after reporting complete tumor regression in preclinical pancreatic-cancer models. 27 November 2025
Pharmaceutical
US biotech Kura Oncology and Japanese specialty pharma Kyowa Kirin have secured early guideline recognition for Komzifti (ziftomenib), their new treatment for a subset of adults with relapsed or refractory acute myeloid leukemia. 27 November 2025
Biotechnology
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) yesterday approved Swiss pharma giant Roche’s
Itovebi (inavolisib (for the treatment of adults with a type of breast cancer called HR-positive, HER2-negative breast cancer. 27 November 2025
Biotechnology
Australia’s Therapeutic Goods Administration (TGA) has issued a safety warning regarding the discontinuation of Prolia (denosumab), originated by US biotech major Amgen, and biosimilar versions of the drug. 27 November 2025
Biotechnology
The UK BioIndustry Association (BIA) has welcomed key measures in yesterday’s Autumn Budget that that broadly support the growth of life science and biotech scale-ups, while flagging concerns over rising costs for laboratory space. 27 November 2025
Pharmaceutical
The US regulator has reported a sharp rise in expected savings after completing its second round of Medicare drug price negotiations, putting a focus on high-spend treatments for cancer and chronic disease. 26 November 2025
Pharmaceutical
The American medicines regulator has approved a reformulated version of ranitidine from USA-based VKT Pharma, restoring the acid-reducing drug to the market after a five-year gap. 26 November 2025
Biotechnology
India’s Sun Pharmaceutical Industries today announced the US Food and Drug Administration (FDA) approved an updated label for Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. 26 November 2025
Biotechnology
Chinese biotech companies are pivoting from "fast-follow" to "smart" first-in-class (FIC) innovation, a shift that is reshaping global licensing deals and driving multinational corporations (MNCs) to integrate more deeply with China’s R&D ecosystem. 26 November 2025
Biotechnology
The US Food and Drug Administration approved AstraZeneca’s Imfinzi (durvalumab) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). 26 November 2025
Biotechnology
Chinese biotech Akeso has secured Breakthrough Therapy Designation for Idafang (ivonescimab) in triple-negative breast cancer, positioning the bispecific antibody to become China’s first next-generation immuno-oncology option in the first-line setting. The Phase III HARMONi BC1/AK112 study is due to complete in December 2026. 26 November 2025
Pharmaceutical
Neurizon has appointed Justine Conway, global head of business development at US animal-health group Elanco, as board observer, further tightening the companies’ partnership. She will join all board and committee meetings without voting rights, bringing long-running transaction and strategy experience from roles in Sydney, London and New York. 26 November 2025
Biotechnology
The US Food and Drug Administration (FDA) has granted accelerated approval of Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. 26 November 2025
Pharmaceutical
In a show of rare bipartisan agreement in the US Congress, lawmakers raised concerns over how the 340B program is driving up costs for patients, taxpayers and employers, and stressed the need for reforming the program, commented trade group Pharmaceuticals Research Manufacturers of America (PhRMA). 26 November 2025
Pharmaceutical
Cantor Fitzgerald analysts have connected with Danish biotech Ascendis Pharma’s on the three-month Prescription Drug User Fee Act (PDUFA) extension of TransCon hGH) CNP (navepegritide) for achondroplasia, which is now scheduled for February 28, 2026. 26 November 2025
Biosimilars
Israel’s Teva Pharmaceutical Industries has announced that the European Commission (EC) has granted marketing authorizations for its two denosumab biosimilar candidates. 25 November 2025
Pharmaceutical
Japanese drugmaker Otsuka has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for centanafadine, an investigational compound for the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents, and adults. 25 November 2025
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