Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.
Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever.
Ipsen SA withdrew Tazverik (tazemetostat) from the U.S. market after evidence emerged of secondary hematological malignancies in an ongoing phase Ib/III study in follicular lymphoma.
Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.
In an all-cash transaction valued at €780 million (US$920 million), Asahi Kasei Corp. offered to buy Aicuris Anti-infective Cures AG, expanding its infectious disease portfolio with a marketed cytomegalovirus product and a herpes treatment nearing an NDA.
In an all-cash transaction valued at €780 million (US$920 million), Asahi Kasei Corp. offered to buy Aicuris Anti-infective Cures AG, expanding its infectious disease portfolio with a marketed cytomegalovirus product and a herpes treatment nearing an NDA.
Innovacell Inc. launched a ¥14.16 billion (US$91.2 million) stock sale on the Tokyo Stock Exchange Feb. 24, ending a near two-year lull of biotech listings in Japan while signaling a dynamic year ahead for cell-based therapeutics.
Astellas Pharma Inc. and Vir Biotechnology Inc. have signed a global co-development pact to advance VIR-5500, Vir’s PRO-XTEN dual-masked CD3 T-cell engager targeting prostate-specific membrane antigen for treating prostate cancer. Under the deal terms, San Francisco-based Vir will receive $335 million in up-front and near-term payments, including $240 million in cash, $75 million in equity investment and a $20 million near-term milestone. Vir is also eligible to receive up to $1.37 billion in development, regulatory and sales-based milestones plus royalties on ex-U.S. sales.
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveporexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1.