Novo Nordisk announced that it will buy Forma Therapeutics, a clinical-stage biotech focused on rare hematologic diseases, in an deal valued at $1.1 billion. The deal is the second billion-dollar sickle cell disease deal the pharmaceutical industry has seen in the last 30 days — Pfizer forked over $5.4 billion in August to buy Global Blood Therapeutics.
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
The drug, Ayvakit, showed a high overall response rate in patients with advanced systemic mastocytosis, a rare type of blood cancer with limited treatment options. Novartis' Rydapt has been approved for advanced SM for several years.
The companies said Tuesday that the FDA had accepted their application for idecabtagene vicleucel, which they resubmitted in July after the agency initially refused to file it in May. The action date is in March of next year.
BMS received approval for Onureg in the continuation setting of acute myeloid leukemia. The drug uses the same pharmaceutical molecule as Vidaza, a drug given via IV or subcutaneously that is used upfront, but it is not intended as a substitute for it.
In a CRL issued for valoctocogene roxaparvovec, the FDA told BioMarin that differences between its Phase I/II and Phase III studies limited the ability to rely on the earlier trial to support durability of effect, which an analyst said likely referred to a product comparability issue.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.
The FDA approved Monjuvi for second-line diffuse large B-cell lymphoma. Though the drug has the same antigen target as approved CAR-T cell therapies, it is designed for patients unable to tolerate such intensive treatments.
The trial, of Xpovio, showed a positive increase in progression-free survival in patients with second-line disease. Xpovio's accelerated approval last year for heavily pretreated patients attracted controversy from the myeloma physician community.
The biotech company's Kite Pharma subsidiary said the FDA had granted priority review for KTE-X19 in mantle cell lymphoma. The company already markets the CAR-T Yescarta for diffuse large B-cell lymphoma.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Data from 11 patients in an MD Anderson study of a cell therapy that uses natural killer (NK) cells from donors instead of patients' own T cells showed a high response rate and low toxicity. A multicenter, international Phase II study is planned.
A Cannacord Genuity analyst pointed to BMS' large pipeline of BCMA-targeting therapies and advanced data, particularly for its CAR-T. However, GlaxoSmithKline has also asserted its anti-BCMA drug could be first past the FDA finish line. But does it matter?
The ANSWer trial will enroll up to 1,000 patients and follow them for up to a year. A smaller feasibility study conducted with Stanford University and Tempus showed an 84% accuracy rate in predicting patient responses to drugs.
The companies said the FDA's Oncologic Drugs Advisory Committee would review their application for Reblozyl in myelodysplastic syndrome. The drug, which won approval for a blood disorder last month, was developed under a partnership between Acceleron and Celgene, which BMS has since acquired.
Data on four of nine patients in a Phase I/II study presented at a conference in Spain met or exceeded the threshold agreed to with regulators for the company's Phase II trial of the therapy, RP-L102.