So much can happen on a daily and weekly basis in the biopharma sphere, and it’s easy to forget what the big stories were a few weeks ago, let alone last year. We thought it would be interesting to look at some of the stories that were making the biopharma news last year at this time (August 12-18, 2018), and see what recent updates there are.
Regeneron was running into issues getting its once-every-12 week dose of Eylea for wet, age-related macular degeneration approved by the FDA, with its application being kicked back due to “ongoing labeling discussions.” This was a particular problem in that Novartis was busy moving forward with its competing treatment, RTH258.
Another story this week last year, was Novartis’ hiring of a new “ethics czar,” in part to deal with fallout from the Cohen mess. Chief Narasimhan had hired Klaus Moosmayer, a prominent German attorney, to the position of Chief Ethics, Risk & Compliance Officer for the company.
What’s the latest? It goes without saying that Novartis is still dealing with ethics issues at this time. Just last week, the latest scandal broke with Novartis being chided by the FDA for not releasing information about data inconsistencies in Zolgensma that they were aware of prior to the drug’s approval in May. Instead, they notified the FDA about potential data manipulation issues in June. Now it’s even coming out that a Novartis insider sold a sizable number of shares before the news became public.
On August 17 of last year, the FDA approved Bristol-Myers Squibb’s Opdivo as the as the first new medication in almost 20 years for certain patients with previously treated small-cell lung cancer. They were approved under the FDA accelerated approval program. The approval was based on overall response rate (ORR) and duration of response (DOR) data. It comes after the FDA reviewed results from the SCLC cohort of the ongoing Phase I/II CheckMate-032 trial.