Johnson & Johnson and Pharmacyclics' new drug Imbruvica won the expanded approval it needed to go beyond a rare disease treatment and reach the blockbuster status it was conceived for. The FDA Wednesday gave Imbruvica accelerated approval for treating chronic lymphocytic leukemia in patients who have received at least one previous therapy.
No one ever climbed the industry ladder without getting some help along the way. And for women, including many of the accomplished top performers in this group, that can be especially important....
Pharmacyclics and Johnson & Johnson are riding high on an accelerated approval for the blockbuster hopeful Imbruvica, and now they've tapped Catalent to aid in commercial manufacturing and ongoing clinical trials for the cancer drug.
Another cancer drug approval, another nosebleed-level price. Johnson & Johnson and Pharmacyclics' breakthrough drug Imbruvica (ibrutinib) won FDA approval yesterday for a rare form of lymphoma. Soon after, the companies said Imbruvica would be priced at more than $90 per pill. At four pills per day, that's about $130,000 per year.
The FDA has come through with an early approval of the BTK drug ibrutinib, a likely new cancer blockbuster from Pharmacyclics (and Johnson & Johnson.
In drug development, everything's a gamble, if you're doing something new and shooting at a big target. But there has to be a reasonable assumption that if safety issues aren't being glossed over and the efficacy data hold up, these top drugs can change standards of care and grab market share. So here's my pick of the likely big winners >>
J&J knows how to do a big licensing deal with some serious short-term incentives tied to it. And that swaggering deal style was on full display this morning when Pharmacyclics announced that the FDA has accepted their NDA on the closely-watched cancer drug ibrutinib, triggering a $75 million milestone payment and bringing its cash tally to at least $375 million.
Two years ago, Quest Diagnostics picked up Celera and its gene-based testing tech for $657 million in cash. And today it cashed in a lottery ticket it picked up in the deal, selling the royalty rights Celera held for the breakthrough cancer drug ibrutinib for $485 million.
In our third annual report on 10 exciting cancer drugs, there are plenty of R&D programs zipping through trials with the blessing of the FDA, which has awarded "breakthrough" status for expedited development to treatments in oncology more than any other field. Read the report >>
Eight months after Johnson & Johnson committed to a $1.1 billion deal package to partner on Genmab's cancer antibody daratumumab, the FDA has blessed the Phase I/II program with its new "breakthrough" designation.