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Astellas Pharma
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Biotechnology
The China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for Padcev (enfortumab vedotin) in combination with Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) as neoadjuvant treatment (before surgery), and then continued after cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin-containing chemotherapy. 9 July 2026
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A clinical-stage pharma company with operations in Roswell (GA), Dublin (Ireland), and Hamilton (Bermuda), dedicated to developing therapies for central nervous system and rare diseases, including orphan and pediatric conditions.
Latest News & Features of interest to Astellas Pharma
Pharmaceutical
Last week’s regulatory news saw the US Food and Drug Administration (FDA) accept Swiss biotech Pharmvaris’ new drug application (NDA) for deucrictibant for the treatment hereditary angioedema (HAE) attacks. The FDA also approved Sanofi’s Sarclisa Escensa. On the M&A front, US drugmaker Vertex announced a $10 billion takeover bid for Crinetics and its rare disease drug Palsonify. Also of note, the UK’s AstraZeneca released disappointing Phase III trial results for its Wainua in cardiopathy. 12 July 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved pharma giant Pfizer and Japanese drugmaker Astellas Pharma’s Padcev (enfortumab vedotin-ejfv) plus Merck & Co’s Keytruda (pembrolizumab) as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility. 10 July 2026
Biotechnology
The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all existing indications of Sarclisa intravenous (IV) formulation. 10 July 2026
Biotechnology
Chinese drugmaker Hansoh Pharma says its GSK-partnered antibody-drug conjugate risvutatug rezetecan, or Ris-Rez, has met the primary endpoint of overall survival in a pivotal Phase III trial in small cell lung cancer. 10 July 2026
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has issued final draft guidance rejecting routine National Health Service (NHS) use of Amgen’s Lumykras (sotorasib) for previously treated KRAS G12C-mutated advanced non-small-cell lung cancer. 10 July 2026
Biosimilars
Israeli drugmaker Teva Pharmaceutical Industries has expanded its biosimilars pipeline through a global licensing agreement with Polpharma Biologics for a proposed copy of Roche’s multiple sclerosis drug Ocrevus (ocrelizumab). 9 July 2026
Biotechnology
The China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for Padcev (enfortumab vedotin) in combination with Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) as neoadjuvant treatment (before surgery), and then continued after cystectomy (surgery) as adjuvant treatment (after surgery), for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin-containing chemotherapy. 9 July 2026
Pharmaceutical
The CARDIO-TTRansform Phase III trial for AstraZeneca and Ionis Pharmaceuticals' Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) did not meet the primary efficacy endpoint. 9 July 2026
Biotechnology
UK biotech company Alchemab Therapeutics has secured a £25 million ($34 million) Series A extension from the British Business Bank, in what the Bank says is its largest direct investment in a life sciences company. 9 July 2026
Biotechnology
US precision oncology biotech Stipple Bio has appointed Roland Gendron as chief business officer as it prepares to move lead candidate STP-100 into early clinical studies. 8 July 2026
Latest In Brief for Astellas Pharma
Pharmaceutical
Codis has agreed to acquire Catalent Pharma Solutions’ Nottingham, UK, facility, expanding its contract development and manufacturing organization (CDMO) capabilities in oral solid dose development and manufacturing. The deal is expected to close in the third quarter of 2026, subject to customary conditions. 7 July 2026
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