Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.
Responding to COVID-19’s wakeup call as it exposes the risks of relying heavily on foreign biopharma supply chains, the U.S. Department of Health and Human Services (HHS) signed a four-year, $354 million agreement with a team of private industry partners, led by Phlow Corp., to expand U.S. manufacturing of essential medicines at risk of shortage during the pandemic and in future public health emergencies.
Except for breakthrough devices and qualifying infectious disease drugs, the footwork for getting Medicare's new technology add-on payment (NTAP) can be more challenging than that needed to win FDA approval. It could be even tougher for products that use artificial intelligence (AI) or that follow a subscription model for pricing.
“Our window of opportunity is closing. If we fail to develop a national coordinated response, based in science, I fear the pandemic will get far worse and be prolonged, causing unprecedented illness and fatalities,” Rick Bright, former director of the Biomedical Advanced Research and Development Authority, said today as he testified at a House subcommittee hearing on the U.S. response to COVID-19.
Innovation is being rewarded under Medicare’s proposed fiscal 2021 Inpatient Prospective Payment System (IPPS) that was unveiled Monday. For starters, the Centers for Medicare and Medicaid Services (CMS) is proposing a new Medicare-severity-diagnosis related group (MS-DRG) specifically for CAR T therapies.
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
DUBLIN – The Innovative Medicines Initiative (IMI), a public-private research partnership between the European Commission (EC) and Europe’s pharmaceutical industry, has boosted funding for a fast-track response to the COVID-19 pandemic from €45 million (US$48.8 million) to €72 million.
Having a COVID-19 therapy approved through an emergency use authorization (EUA) is not the same as having access to it, even if it’s free. Accounting for one-third of the nearly 4 million COVID-19 cases confirmed globally as of Monday and 28.5% of the 278,957 deaths, the U.S. is getting 40% of the 1.5 million vials of remdesivir Gilead Sciences Inc. is donating worldwide.
Three biopharma drugs are up for FDA approval this week, including one new chemical entity, dasotraline, from Sunovion Pharmaceuticals Inc. to treat binge eating disorder, and two other candidates that are part of supplemental filings for expanded indications.
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
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