If the FDA follows the advice of its Antimicrobial Drugs Advisory Committee, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will become the first drug approved in the U.S. to treat resistant or refractory cytomegalovirus infection and disease in both solid organ and hematopoietic stem cell transplant recipients.
Selecta Biosciences Inc. joined a licensing agreement with Takeda Pharmaceutical Co. Ltd. to develop AAV-driven gene therapies for two lysosomal storage disorders that could bring Watertown, Mass.-based Selecta up to $1.124 billion. The payments depend upon hitting development or commercial milestones. Selecta is also receiving an undisclosed up-front payment and is eligible for tiered royalties on commercial sales.
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
Takeda Pharmaceutical Co. Ltd. and JCR Pharmaceuticals Co. Ltd. have negotiated a geographically-focused licensing deal to develop and commercialize JR-141 (pabinafusp alfa), a potential therapy for mucopolysaccharidosis type II, also known as Hunter syndrome.
After nearly 20 years in development, Takeda Pharmaceutical Co. Ltd.’s antiviral drug, maribavir, will get its day before the FDA’s Antimicrobial Drugs Advisory Committee Oct. 7. During the course of its development by various companies, the drug’s indication has morphed from a prophylaxis to a treatment of resistant or refractory cytomegalovirus infection in both solid organ and hematopoietic stem cell transplant recipients.
Selecta Biosciences Inc. joined a licensing agreement with Takeda Pharmaceutical Co. Ltd. to develop AAV-driven gene therapies for two lysosomal storage disorders that could bring Watertown, Mass.-based Selecta up to $1.124 billion. The payments depend upon hitting development or commercial milestones. Selecta is also receiving an undisclosed up-front payment and is eligible for tiered royalties on commercial sales.
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
Takeda Pharmaceutical Co. Ltd. has grabbed a slice of the non-small-cell lung cancer (NSCLC) market, becoming the first company to gain FDA approval for an oral drug targeted against a rare form of the disease.
Hillevax Inc., a company developing a vaccine to prevent moderate to severe acute gastroenteritis caused by norovirus infection, has raised $135 million in crossover financing to support further clinical development of the candidate, HIL-214.
Recently published phase II data with Takeda Pharmaceutical Co. Ltd.’s TAK-906 (trazpiroben), a dopamine D2/D3 receptor antagonist, fueled hope for patients as Processa Pharmaceuticals Inc. proceeds with a different – and more focused – approach against gastroparesis.