Four years after a private equity acquisition took Parexel private, the contract research organization is being acquired by two private equity firms for $8.5 billion. It’s the latest in a series of acquisitions to hit the CRO sector this year.
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.
Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches.
In a series of tweets, a myeloma expert called the FDA accelerated approval of Karyopharm's Xpovio "baffling" and "incorrect" and the drug's $22,000 monthly price tag "outrageous." A member of ODAC also agreed that the drug should not have been approved so early. The company defended the drug and its pricing.
Data from the ongoing Phase III study, which have not been publicly disclosed, influenced the decision to approve the drug, Xpovio, in "penta-refractory" myeloma.
Shares of the company fell dramatically Tuesday after it announced that the agency had rejected its application for the drug celiprolol in vascular Ehlers-Danlos syndrome.
Shares of the company were down more than 12 percent in premarket trading on the Nasdaq Wednesday. They had already fallen 46 percent Friday after the release of AdCom briefing documents.
As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers.
Drugmaker applies for selinexor in penta-refractory multiple myeloma, in which bluebird's bb2121 has also shown efficacy.
Kidney stones are on the rise. One cause is a condition called hyperoxaluria – a potentially serious metabolic disorder that’s found in about 20-30 percent of patients with recurrent stones. It that lead to chronic kidney disease, end-stage renal disease and dialysis. To date, there’s no approved therapy to treat hyperoxaluria. An enzyme that can degrade oxalates – the […]
Beacon Endoscopic Corp. has raised $1.2 million in debt financing from existing investors to fund commercial growth for its bnx™ fine needle aspiration for EUS in the US and abroad, company CEO and President Bill Densel said. Beacon made its regulatory filing to the SEC on July 22. The bnx™ system is “designed to reduce […]
A medical technology company with electronic medication reminders to improve adherence has raised $1 million for new products that will address health problems like dementia.
The future looks bright for the integrated specialty pharmacy model – for health systems, providers, and most importantly, for patients.