Company news: Gilead and Janssen

Share this article:

Gilead filed NDAs for two new HIV-infection fighters, the integrase inhibitor elvitegravir and the “boosting” agent cobicistat. Both drugs are also components of the Quad once-daily single tablet HIV regimen, currently under review by US and European authorities. The filings follow Gilead agreements with Bristol-Myers Squibb and Janssen to develop fixed-dose combinations of cobicistat with darunavir and atazanavir, respectively. The Quad contains four Gilead compounds: elvitegravir, cobicistat and Truvada, which itself is a combination of Gilead's emtricitabine and tenofovir disoproxil fumarate.

Janssen submitted an NDA for bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults. The firm is seeking accelerated approval. Bedaquiline would be the first drug with a new mechanism of action for TB in more than 40 years and the first and only one specifically indicated for MDR-TB.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.

Baxter seeks Cambridge, Mass. HQ

Illinois may be tempted to offer tax incentives for the firm to stay put.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.