Novartis
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Maryland-based REGENXBIO is expanding its gene therapy pipeline to include a new treatment for late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, one of the most common forms of Batten disease.
The United Kingdom’s government-funded health service isn’t being so nice to Gilead Science’s CAR-T blood cancer treatment Yescarta. The country’s National Institute for Health and Care Excellence (NICE) said the therapy is too expensive for the agency to justify.
Who made a splash in the biotech world this week? Here are some notable people.
Novartis announced that its BYL719 (alpelisib) met the primary endpoint of progression-free survival (PFS) in its Phase III SOLAR-1 trial. The drug is an alpha-specific PI3K inhibitor, a category of cancer drugs that has a troubling history of adverse events.
By many standards, and certainly by the way the media covers it and industry promotes it, immuno-oncology therapies using CAR-T are revolutionizing cancer treatments. But what if, as the saying goes, they threw a revolution and nobody came? Or more precisely, what if they threw a revolution and no one was willing to pay for it?
According to the National Cancer Institute (NCI), pancreatic cancer is relatively rare, with about 55,440 cases diagnosed annually, representing about 3.2 percent of new cancer cases. But each year, 44,330 Americans die from the disease, or about 7.3 percent of cancer deaths.
The U.S. Food and Drug Administration (FDA) granted Merck & Co.’s Keytruda another approval, this one in combination with Alimta (pemetrexed) and platinum chemotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
H. Gilbert Welch, a health care policy scholar at Dartmouth College, reportedly plagiarized part of the contents in a 2016 New England Journal of Medicine article. The article focused on breast cancer screening and the increased likelihood of tumors being overdiagnosed.
The U.S. Food and Drug Administration has done another about-face. Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA has now approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
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