DRUG DEVELOPMENT DECONSTRUCTOR MANIFESTO: : “Tell me how you read and I'll tell you who you are.” ― Martin Heidegger
Tuesday, December 31, 2013
Monday, December 30, 2013
Sunday, December 29, 2013
Saturday, December 28, 2013
Targeted failure of the week. Post No 129. AXL1717
Axelar AB (Solna, Sweden) said twice-daily oral AXL1717 missed the primary endpoint of improving the 12-week progression-free survival (PFS) rate vs. docetaxel in the Phase II AXL-003 trial to treat non-small cell lung cancer (NSCLC) (25.9% vs. 39%, p=0.19). AXL1717 also missed the secondary endpoints of improving median overall survival (OS) (7.52 vs. 9.41 months, p=0.91) and PFS (2.83 vs. 2.85 months, p=0.32) vs. docetaxel. Axelar said some early episodes of neutropenia in the AXL1717 arm developed into serious events, some of which were fatal.
In April, Axelar reported interim data from the trial showing that AXL1717 led to a "similar" 12-week PFS rate as docetaxel, but the company declined to disclose details. The open-label, international trial enrolled 99 evaluable patients with previously treated, locally advanced or metastatic NSCLC.
On a conference call to discuss the data, the company said a "rational way forward" would be to evaluate AXL1717 as third-line treatment of NSCLC. Axelar said it is "planning future studies in parallel with ongoing partner discussions," but could not be reached for details. AXL1717 is an oral small molecule insulin-like growth factor-1 (IGF-1) receptor (IGF1R; CD221) inhibitor, though the company said there is evidence that AXL1717 also suppresses tumor cell division by arresting cells in mitosis.
Friday, December 27, 2013
Thursday, December 26, 2013
Wednesday, December 25, 2013
Drop in UK death rates from cancer
Research is the key cause behind the 22% drop in UK death rates from cancer
reported between 1990 and 2011, says new research.
In 1990, 220 in every 100,000 people died of cancer ,but this figure fell
to 170 per 100,000 in 2011, due to improved knowledge about preventing the
disease, surgical techniques, precisely-targeted radiotherapy and more effective
drugs all boosting the outcome for patients
Tuesday, December 24, 2013
Monday, December 23, 2013
Sunday, December 22, 2013
Saturday, December 21, 2013
Friday, December 20, 2013
Well, really BIG deals for Big Pharma!
The pharmaceutical giant AstraZeneca said on Thursday that it would pay up to $4.1 billion to acquire Bristol-Myers Squibb’s stake in an alliance to jointly develop diabetes drugs.
Thursday, December 19, 2013
Wednesday, December 18, 2013
When erection is painfull...
For parents who worry those ADHD pills may not be appropriate, here is another reason for concern – the FDA has just issued a notice saying methylphenidate products, which include Ritalin and Concerta, may cause prolonged and sometimes painful erections known as priapism. If there is any good news it would be this sort of thing is rare. Still, who wants to learn the hard way? Pardon the pun.Tuesday, December 17, 2013
Monday, December 16, 2013
Sunday, December 15, 2013
Saturday, December 14, 2013
Friday, December 13, 2013
Your Vote Counts: Who Is the Worst Biotech CEO of 2013?
What a nice approach! The next to come should be:- the worst targeted drug
- the worst Big Pharma Company
- the worst indication (just like bent penis or painful sex)
Avastin - bad news again
Patients treated with chemotherapy plus trastuzumab (Herceptin) had 92% iDFS with or without the bevacizumab. Subgroup analysis did not identify any group of patients that benefited from the addition of the angiogenesis inhibitor.
Thursday, December 12, 2013
Tuesday, December 10, 2013
Monday, December 9, 2013
Sunday, December 8, 2013
Saturday, December 7, 2013
Bent penis? 5%of U.S. men are affected! Not a problem anymore!
Post-modern Health problems - not a joke!!!
WASHINGTON (AP) -- The Food and Drug Administration on Friday approved the first drug to treat an unusual condition that causes painful, curved erections in men.
FDA says the injectable drug is the first non-surgical treatment for the disease.
Drugmaker Auxilium Pharmaceuticals estimates 5 percent of U.S. men are affected. - It sounds like an epidemic!
Xiaflex was previously approved in 2010 to treat a hand disease that interferes with patients' ability to straighten their fingers. The FDA said in its release that Xiaflex is believed to treat Peyronie's disease by breaking down collagen plaque that builds up in the penis and causes the deformity.
The FDA said it is limiting distribution of the drug to certified physicians and health care centers due to serious potential side effects, including injury of the penis. Health care professionals must enroll and complete a training program before prescribing the drug.
The FDA approved Xiaflex for its new use based on two studies of 832 men with Peyronie's disease. Patients received up to eight injections of the drug and were then followed for a year to see if their condition improved. Patients who received the drug reported significantly fewer problems than those who received a dummy injection.
The drug was developed by BioSpecifics Technologies Corp. of Lynbrook, N.Y., and submitted to the FDA by Chesterbrook, Pa.-based Auxilium Pharmaceuticals Inc.
Shares of Auxilium rose $1.80, or 9.3 percent, to $21.13 in afternoon trading.
Friday, December 6, 2013
Thursday, December 5, 2013
Wednesday, December 4, 2013
Authorship For Sale. Why not?
Very interesting Reading:
"There are some authors who don't have much use for their papers after they're published, and they can be transferred to you," a sales agent for a company called Wanfang Huizhi told a Science reporter posing as a scientist. Wanfang Huizhi, the agent explained, acts as an intermediary between researchers with forthcoming papers in good journals and scientists needing to snag publications. The company would sell the title of co–first author on the cancer paper for 90,000 yuan ($14,800). Adding two names—co–first author and co–corresponding author—would run $26,300, with a deposit due upon acceptance and the rest on publication. A purported sales document from Wanfang Huizhi obtained by Science touts the convenience of this kind of arrangement: "You only need to pay attention to your academic research. The heavy labor can be left to us. Our service can help you make progress in your academic path!"
And the $14,800 is not a big deal for serious researchers!
And the $14,800 is not a big deal for serious researchers!
