July 18, 2024

Novartis hedges on filing plans for MorphoSys drug

From my colleague Drew Joseph: Last year, when MorphoSys announced Phase 3 data for its experimental myelofibrosis drug, it said it planned to file for approval for the medicine, called pelabresib. And in February, when Novartis announced it was buying MorphoSys for nearly $3 billion, the Swiss pharma giant said it planned to submit the drug to the FDA this year.

But on Thursday, amid questions about the strength of the drug's data profile, Novartis CFO Harry Kirsch said "it's too early to say" whether the company would indeed apply for approval this year. Not only that, Kirsch said the company needed to see additional, longer-term data.

Kirsch's remarks, on a press call tied to the company's second quarter earnings, are sure to inflame the scrutiny over Novartis's purchase of MorphoSys, a deal that led to internal concern at the company, as STAT previously reported.

lobbying

BIO's new CEO talks vaccines and China

My colleagues Rachel Cohrs Zhang and John Wilkerson sat down with John Crowley to talk about his role leading the biotech industry's largest trade group.

They discussed how Crowley, a Republican, feels about growing anti-vax sentiment and the Republican party's mistrust of entities like the FDA and NIH. They also talked about the BIOSECURE Act and how he's thinking about members who have ties to China.

people moves

Gilead to switch up R&D leadership

Gilead said yesterday that its chief medical officer, Merdad Parsey, will be leaving. He'll stay on until the first quarter of next year as the company looks for a successor.

This change comes as Gilead has struggled to move beyond its core portfolio of HIV medicines and into new areas like oncology. Gilead shares rose yesterday following the announcement, indicating investors' hopes that a new research chief could spur a turnaround in Gilead's R&D efforts.

oncology

A drug to expand access to bone marrow transplants

Receiving a bone marrow transplant for blood cancer treatment can be very difficult since patients want to find donors who are a perfect match. A new study suggests that a chemotherapy called cyclophosphamide could make the process of finding a donor easier.

The study found that donors whose bone marrow did not as closely resemble that of the patient's provided similar outcomes as matched donors, so long as patients received cyclophosphamide.