Big pharmas are having a good year so far in terms of FDA approvals.
This opinion piece presents the opinions of the author. It does not necessarily reflect the views of BioSpace.
Novartis has been having a good year, but the past month has seen the Swiss pharma giant facing heightened competition on at least two new fronts. Gilead’s Yescarta becomes the second CAR-T drug approved this year, and addresses a much larger market than Novartis’s Kymriah, at least under its current label. Priced cautiously, both companies are trying to avoid the fate of Dendreon’s Provenge. Also since our last issue, Eli Lilly won approval for Verzenio (abemaciclib), a cyclin-dependent kinase inhibitor in the same class as Novartis’s Kisqali and Pfizer’s Ibrance. Lilly will go after the same HR-positive, HER-2 negative breast cancer market but may struggle with a side effect profile that includes a higher incidence of diarrhea.
Here’s a roundup of these stories and other top FDA actions from the past month.
- Gilead’s $12B Bet Pays Off in Two Months After the FDA Approves Kite’s Revolutionary CAR-T Therapy
- FDA Approves Eli Lilly’s New Treatment For Certain Advanced Or Metastatic Breast Cancers
- Spark Therapeutics Jumps as FDA Panel Backs Breakthrough Gene Therapy
- FDA Calls Novartis’ Melanoma Combo Drug a Breakthrough
- FDA Advisors Officially Turn Down PTC Therapeutics’ DMD Drug, Data Inconclusiv
Read More From Karl Thiel:
Novartis Has Set a Tricky Precedent in Gene Therapy
