Novartis Impresses Where Others Have Failed
There is some good news from the clinic today. Novartis reported data on LCZ696, a combination therapy for congestive heart failure, and the results have really grabbed a lot of attention. (The trial...
View ArticleA VC Firm Touts Its Successes – And Its Failures
Here’s what sounds like a good idea from VC firm Index Ventures, from the latest issue of BioCentury (same one I referenced the other day). Like many others in the biopharma venture capital world,...
View ArticleRemember Vytorin? The Data Are Finally Coming.
If you follow cardiovascular therapies, you’ll no doubt have seen that a bit of information has come out on Merck’s long, long, long-running IMPROVE-IT trial. That is the massive outcomes study for...
View ArticleVytorin Actually Works
The data from the IMPROVE-IT trial on cardiovascular outcomes for Vytorin have been released. And the combination met the primary endpoint: fewer heart attacks and strokes compared to those already on...
View ArticleAmgen Claims It All
There’s plenty of excitement about PCSK9, the latest LDL-lowering pathway to make it deep into the clinic. You can tell that companies (and investors) have high hopes for it, since it’s heading right...
View ArticleHow Not to Handle Your Clinical Data
We turn now to Orexigen, one of the small companies trying to make headway in the obesity market. Earlier this year, a patent application from them published, claiming that their drug (Contrave, a...
View ArticleDefibrillating Dalcetrapib
In 2012, Roche halted development of their CETP inhibitor dalcetrapib, part of what (so far) has been a grim chapter in cardiovascular drug development. At the time, this was put down to lack of...
View ArticlePCSK9 at the FDA
So an FDA advisory committee met yesterday to consider the PCSK9 antibody from Regeneron and Sanofi, and today it’s the turn of Amgen’s candidate. These, as anyone with even a passing interest in...
View ArticleClinical Trials: Getting Much Worse, or Much Better?
Here’s a very interesting overview of the clinical trials funded (55 total) by the National Heart, Lung, and Blood Institute (NHLBI) over the years 1970-2012. Breaking them into pre-2000 and post-2000...
View ArticlePCSK9 In the Details
The PCSK9 inhibitors are a class of drugs from which great things are expected. The first ones hitting the market are antibodies, and blocking this enzyme, which is involved in cholesterol homeostasis,...
View ArticlePrions In the News (Unfortunately)
Let’s talk about proteins for a few minutes – nasty, unfriendly proteins, of the sort that will ball up and crash out of solution the first chance they get. Anyone working in a protein purification lab...
View ArticleCETP Failure: Now It’s Lilly’s Turn
It’s been a while since CETP came up on this site as a drug target. This has been many companies’ best shot at an HDL-raising therapy, to go along with the LDL-lowering effects of the statins (and now...
View ArticleA Low-Cholesterol Vaccination?
We have dueling PCSK9 antibodies on the market – Praluent (alirocumab) and Repatha (evolocumab) – and they’re both out there lowering LDL levels as we speak. (Whether these have the desired long-term...
View ArticleOnward With CETP!
Merck is damning the torpedoes and going ahead with its CETP program. A committee has reviewed the data so far for futility, and recommended no changes, so (as FierceBiotech says), they’re pretty much...
View ArticleWhat a Brief Regeneron Panic Tells Us
Matthew Herper has a good article on a recent (and fortunately short) scare for Regeneron. Several investors had used the Freedom of Information Act to get FDA adverse-event reporting on the PCSK9...
View ArticleUp to Speed on Meldonium
I will freely admit that I had never heard of meldonium (aka mildronate) until yesterday, when it made headlines across the sports pages (and cost Maria Sharapova a great deal of endorsement money)....
View ArticleCETP Finally Heads to the Trash Heap?
The tale of CETP (cholesteryl ester transfer protein) as a drug target has been long, and convoluted, and expensive, and horrendously disappointing. Pfizer failed, Roche failed, several other companies...
View ArticleFrom the Far Corner of the Basement
To go along with that recent CETP trial news, here’s another one for the “We don’t know much about human lipid handing” file. A dietary study originally done back in the 1960s and 1970s has been...
View ArticleOnce More Into the CETP, Friends
So folks, let’s raise a bunch of money and pile back into CETP! You know, that great cardiovascular target that has been an absolute vale of tears for every big drug company that’s tried to develop it?...
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Is Selective Ribosome Stalling Possible? Apparently So
PCSK9 is a drug target that’s famous in several directions. If you’re interesting in human genetics, it’s famous as an example of a “human knockout” – people with nonfunctional PCSK9, and there are a...
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