Drug Development, Protocols

Protocols: With Ninlaro sales suffering, Takeda launches huge multiple myeloma study; Medivir splitting, spinning R&D into a separate company

Takeda is rolling out a major new study involving multiple myeloma patients. Researchers are recruiting 5,000 patients to track their real world experience in being treated for the disease. Takeda bagged an FDA approval for Ninlaro last fall, but they’ve experienced disappointing sales so far. It’s also been blocked in Europe.

Sweden’s Medivir is pushing ahead with plans to divide the company into two independent entities, splitting its commercial operations and R&D portfolio. The move is expected to wrap up by the end of this year.

The University of Minnesota is suing Gilead over the patents for its blockbuster hep C drug Sovaldi. The university claims that Gilead infringed on patents assigned to the institution by one of its professors, Dr. Carston Wagner. Gilead, though, is disputing the suit.

Shares of The Medicines Company $MDCO slid a bit after the biotech said that it would have to continue with its study of the anticholesterol drug MDCO-216 after failing to qualify for an early success during the interim analysis.

Celgene has selected a NASH program that its discovery partner Forma will now take into Phase I later in the year. If successful, Celgene will then have the option to move forward on its own.

The FDA has accepted CSL Behring’s BLA for its C1-Esterase Inhibitor (C1-INH) Human replacement therapy, CSL830, as prophylaxis to prevent hereditary angioedema attacks.

Now rivals in the PARP field, Clovis has amended its licensing package with Pfizer for rucaparib, deferring milestones as it prepares to follow up on its marketing application and field its first drug.


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RAPS Regulatory Convergence 2017