Astellas Pharma Inc. has inaugurated a new $90 million, state-of-the-art center at 480 Forbes Boulevard in South San Francisco, California. This 154,000-square-foot laboratory and office complex is a significant expansion of the company’s commitment to the vibrant biotech ecosystem of South San Francisco and serves as a central hub for its West Coast operations. The […]
In a significant development in the fight against urothelial cancer, Astellas Pharma Inc. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded priority review status to its Supplemental New Drug Application (sNDA) for PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) as a first-line treatment for adults with previously untreated locally advanced […]
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc. await the European Medicines Agency’s (EMA) review of their recent application. This significant step involves a Type II variation application for PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab), targeting first-line treatment of adult patients with previously untreated […]
Japanese pharma company Astellas Pharma has agreed to acquire Nasdaq-listed Iveric Bio in an all-cash deal worth around $5.9 billion with an aim to create a world-class ophthalmology player, while advancing the former’s primary focus on blindness and regeneration. Based in New Jersey, Iveric Bio is a biopharma company engaged in discovering and developing novel […]
Aurobindo Pharma said that its fully-owned subsidiary — Eugia Pharma Specialities has secured final approval for Amphotericin B Liposome for Injection, 50 mg from the US Food & Drug Administration (FDA). The approved product is bioequivalent and therapeutically equivalent to Astellas Pharma US’ AmBisome Liposome for Injection, 50 mg/vial. Amphotericin B Liposome for Injection is […]
Astellas Pharma has signed an agreement to acquire a 15% stake in US-based biotech company Taysha GeneTherapies through an investment of $50 million. As part of the transaction, the Japanese pharmaceutical company will get an exclusive option to license Taysha GeneTherapies’ TSHA-102 and TSHA-120, two clinical-stage, single-gene therapies for rare genetic diseases. TSHA-102 is a […]
Astellas Pharma said that a participant in the ASPIRO clinical trial of AT132, who had developed a serious adverse event earlier this month, has passed away. The Japanese pharma company said that the cause of death is yet to be determined. The ASPIRO clinical trial is being held in patients with X-linked Myotubular Myopathy (XLMTM), which is […]
Roxadustat approval – Astellas Pharma and FibroGen have secured approval for EVRENZO (roxadustat) in Japan for the treatment of anemia associated with chronic kidney disease (CKD) in adults, who are not on dialysis. The approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) is the second in the country for roxadustat through the […]
PADCEV, KEYTRUDA combination : Astellas Pharma and Seattle Genetics said that the combination of PADCEV (enfortumab vedotin-ejfv) and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) has been given breakthrough therapy designation from the US Food and Drug Administration (FDA) in first-line advanced bladder cancer. The FDA breakthrough therapy status for PADCEV, KEYTRUDA combination is for the treatment […]
Astellas acquisition of Xyphos : Japanese pharma company Astellas Pharma has acquired US biotech company Xyphos Biosciences in a deal worth up to $665 million as per the latest pharma acquisition news. The acquisition of Xyphos Biosciences gives Astellas Pharma access to the former’s ACCEL technology platform alongside its immuno-oncology talent to develop new and […]