It seems safe to say we are officially done with snow. Winter is finally at our backs. In the rear view mirror. Yes, we have shifted gears into that very, very short time of the spring – at least here in the Mid-Atlantic region – when you can wear a smart cotton sweater. Earlier it was too cold. In a few weeks it will be too hot. So this is the very narrow fashion window. It is a new day.
But it is the old week and we are at the end of it. This week we had a new approval in oncology, reports of a banner year in generic approvals, and an update to Zika news and new progress against an old killer.
- FDA Approves CLL Treatment - The agency announced the approval of Venclexta (venetoclas) for use in the treatment of patients with chronic lympohcytiuc leukemia (CLL), one of the most common forms of leukemia in adults, who have a chromosomal abnormality called 17p deletion, ascertained through an approved companion diagnostic test, and who have been treated with at least one other prior therapy. The drug targets a protein that supports cancer cell growth and is overexpressed in many patients with CLL. Venclexta had breakthrough therapy, priority review, and accelerated approval as well as orphan drug status.
- Banner Year for Generic Approvals – The good folks at the Regulatory Affairs Professionals Society (RAPS) reported this week that with over 700 approvals and tentative approvals, the ok for generic drugs hit an all-time high during 2015. As is well known, the more generics in a category that are on the market, there accordingly is a downward pressure on the price and as RAPS noted in their piece, generic drugs account for 88 percent of all prescriptions written on the U.S. This follows a year in which approvals for new drugs was also in full gear.
- Zika Developments of Note - As regular readers may deduce, I believe that as we approach summer, the unfolding developments related to Zika are important to note and so from time to time here, newsworthy updates may be provided in the Weekly Roundup. This week, comments from CDC indicated that understanding of the impacts of Zika were unfolding and that more clearly demonstrated links between the virus and potential effects on those it infects, including the phrase that Zika was “scarier than initially thought”. More evidence appeared regarding the sexual transmission of Zika.
- NIH Maps Gene for Pneumocystis – In the earliest days of the AIDS epidemic in the 1980s, there was no test for infection and one of the signs that gay men everywhere tried to self detect was whether or not they were experiencing a shortness of breath. That is because it was a symptom of one of the worst opportunistic infections brought on by a compromised immune system, pneumocystis pneumonia. As one of the more prevalent opportunistic infections, it killed thousands but culturing it in the lab to research it evaded science. This week NIH announced that it had sequenced the genome which, the agency said, could facilitate efforts to culture the organism, facilitating the pathway to screen for effective treatments.
That’s it for me this week folks. We are in store for a beautiful weekend and I hope wherever you are, your’s is as well, indoors and out.