Geron Corporation’s Rytelo is now FDA approved for treating anemia caused by myelodysplastic syndromes. The new drug will compete against Reblozyl, a blockbuster Bristol Myers Squibb medicine.
Eli Lilly’s Jaypirca is now approved for treating three types of blood cancers. While Jaypirca blocks a target already addressed by other cancer therapies, the Lilly molecule does it in a way that sets it apart from the rest of its drug class.
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Servier drug Tibsovo is now approved for treating advanced cases of myelodysplastic syndrome that have an IDH1 mutation. It’s the first approval of a targeted therapy for this type of cancer.
FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.
Swedish Orphan Biovitrum is acquiring CTI Biopharma in a $1.7 billion deal centered on the biotech’s commercialized drug for the blood cancer myelofibrosis. Sobi says the drug, Vonjo, complements one of its own assets approved for a different blood disorder.
Polycythemia vera, a rare blood cancer characterized by the overproduction of red blood cells, now has its first FDA-approved drug treatment. The agency awarded the regulatory nod to a PharmaEssentia drug that reduces the levels of those blood cells.
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The San Francisco-based company aims to complete at least one Phase III study by 2025, and it is weighing an IPO next year to fund more.
New York-based Stemline won Food and Drug Administration approval in December 2018 for Elzonris, a drug for blastic plasmacytoid dendritic cell neoplasm, or BPDCN, an extremely rare but aggressive form of leukemia.
The companies will use Novo Nordisk's experience with hemophilia and bluebird's TALENs-based genome editing technology, megaTAL, with a particular focus on hemophilia A.
Notable CEO Matthew De Silva said the company has been able to successfully replicate its automated system, allowing for the export of the company's technology and growth of its commercial use cases.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
In a phone interview, CEO Jakob Lindberg indicated that data so far showed a study was doing well in terms of progression-free survival.
Bispecific antibodies like Amgen's AMG 420 could present some competition to CAR-Ts. But could sequential use of the therapies - which target the same antigen - be possible?