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Morning! Today, we learn there are some serious safety concerns around an experimental blood cancer drug from MorphoSys that has been the centerpiece of Novartis’ plan to acquire the company for $3 billion. Also, Doctors Without Borders is challenging the pharmaceutical industry to be more transparent about its dollars and cents, and we see more movement in the BIOSECURE Act.
The need-to-know this morning
- Ono Pharmaceutical of Japan is buying Boston-based Deciphera Pharmaceuticals, a maker of cancer drugs, for $2.4 billion.
- Daiichi Sankyo and AstraZeneca said their targeted cancer drug Enhertu showed a statistically significant and clinically meaningful slowing of tumor progression in a randomized, Phase 3 study involving patients with hormone-positive, HER2-low metastatic breast cancer.
- The FDA approved a new treatment from X4 Pharmaceuticals for the treatment of WHIM Syndrome, an immune disorder that leads to serious and frequent infections. The new drug will be marketed under the brand name Xolremdi.
- Repertoire Immune Medicines, a startup backed by Flagship Pioneering, announced a research partnership with Bristol Myers Squibb to develop therapeutic vaccines for autoimmune diseases.
- Prime Medicine said it received FDA clearance to start the first clinical trial of a therapy based on prime editing, an emerging gene-editing technology. The drug, called PM359, will be investigated in a Phase 1-2 study of chronic granulomatous disease.
Safety issues emerge with MorphoSys blood cancer drug
There’s concern over the safety of pelabresib, an experimental treatment made by MorphoSys, STAT’s Adam Feuerstein reports. The drug, which is being studied in myelofibrosis, is the linchpin of a $3 billion acquisition by Novartis. Physicians are reporting that patients given pelabresib have rapidly progressed from myelofibrosis, a bone marrow cancer, to acute myeloid leukemia, a more aggressive and deadly blood cancer.
