DRUG DEVELOPMENT DECONSTRUCTOR MANIFESTO: : “Tell me how you read and I'll tell you who you are.” ― Martin Heidegger
Thursday, October 31, 2013
Targeted failure of the week. Post No 113. MM-121
Another mAbs messssss...
From here.
Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) fell $0.64 (19%) to $2.74 on Wednesday after reporting that MM-121 plus paclitaxel missed the primary endpoint of improving progression-free survival (PFS) vs. paclitaxel alone in a Phase II trial to treat platinum-resistant or refractory advanced ovarian cancer. In August, Merrimack said a pre-specified interim analysis showed MM-121 would not meet the endpoint. At the time, the company said it would continue the trial based on "expectations of the potential for subgroup benefit." MM-121 is a human mAb against epidermal growth factor receptor 3 (EGFR3; HER3; ErbB3).
From here.
Merrimack Pharmaceuticals Inc. (NASDAQ:MACK) fell $0.64 (19%) to $2.74 on Wednesday after reporting that MM-121 plus paclitaxel missed the primary endpoint of improving progression-free survival (PFS) vs. paclitaxel alone in a Phase II trial to treat platinum-resistant or refractory advanced ovarian cancer. In August, Merrimack said a pre-specified interim analysis showed MM-121 would not meet the endpoint. At the time, the company said it would continue the trial based on "expectations of the potential for subgroup benefit." MM-121 is a human mAb against epidermal growth factor receptor 3 (EGFR3; HER3; ErbB3).
On Wednesday, Merrimack said an ongoing analysis of an undisclosed pre-specified set of biomarkers mechanistically linked to EGFR3 signaling identified a potential subpopulation of patients benefiting from MM-121 plus paclitaxel. Merrimack also said an increase in the rate of pulmonary embolism was reported in the MM-121 plus paclitaxel arm compared to the paclitaxel alone arm (5% vs. 1.2%). The company said that none of the pulmonary embolisms were fatal, led to treatment discontinuation or were assessed as treatment-related by the study investigators.
The open-label, international trial enrolled 223 patients with platinum-resistant or refractory advanced ovarian cancer. Merrimack said it will work with partner Sanofi (Euronext:SAN; NYSE:SNY) to determine next steps, but declined to disclose details.
Wednesday, October 30, 2013
Tuesday, October 29, 2013
Monday, October 28, 2013
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Sunday, October 27, 2013
Saturday, October 26, 2013
Friday, October 25, 2013
Quote of the day
«Если какой‑то прием не
работает, я пробую что‑то еще, поскольку я знаю, что обязательно что‑то
сработает. Всегда что‑то срабатывает. Надо просто найти, что».
Hacker Eric
Thursday, October 24, 2013
Wednesday, October 23, 2013
Tuesday, October 22, 2013
Big Pharma and fake?
From here
A Bristol-Myers Squibb researcher faked or falsified data in grant applications to the US National Institutes of Health and American Heart Association, as well as his PhD thesis and two published papers, according to the US Department of Health & Human Services Office of Research Integrity (see this). The disclosure was first reported by Retraction Watch.
Instances of falsified data have caused considerable embarrassment to other large drugmakers this year. Both Novartis (NVS) and GlaxoSmithKline (GSK) were embroiled in scandals in Japan and China, respectively (read here and here). However, the examples cited by the ORI apparently took place before the researcher began work at Bristol-Myers. A Bristol-Myers (BMY) spokeswoman declined to comment.
Monday, October 21, 2013
The 3 Best-Selling Drugs in the World
The 3 Best-Selling Drugs in the World are here:Humira -- estimated 2013 sales: $10.1 billion
Remicade -- estimated 2013 sales: $8.7 billion
Advair -- estimated 2013 sales: $8.6 billion
Just be impressed!
Sunday, October 20, 2013
Saturday, October 19, 2013
Targeted failure of the week. Post No 112. Ponatinib, Iclusig
Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) fell $1.83 (41%) to $2.67 on Friday after discontinuing the confirmatory Phase III EPIC trial evaluating Iclusig ponatinib in newly diagnosed leukemia patients due to arterial thrombotic events observed in patients treated with the drug. Ariad said the decision was based on an analysis of safety data from the trial that was conducted after FDA placed a partial clinical hold last week on all trials of Iclusig. EPIC had enrolled 307 patients of a planned 500. Friday, October 18, 2013
The 5 Diseases Americans Fear the Most or Health as a critical resource
From hereNo. 5: Diabetes (6%)
No. 4: Stroke (8%)
No. 3: Heart disease (8%)
No. 2: Alzheimer's disease (31%)
No. 1: Cancer (41%)
Thursday, October 17, 2013
Wednesday, October 16, 2013
Targeted failure of the week. Post No 111. Krystexxa's pegylated disaster
Krystexxxxxxxxxxxa-hhhhkhkhkh. Well, it is not only targeted failure but a pegylated disaster:
And what happend?
Savient listed total assets of about $74 million and liabilities of $260 million as of June 30, court documents filed on Monday showed.
From Wiki: Pegloticase (or Krystexxa) is a tetrameric peptide composed of four identical chains of about 300 amino acids each. Approximately nine of the 30 lysine residues in each chain are pegylated. These side chains consist of about 225 ethylene glycol units each.
And what happend?
Savient listed total assets of about $74 million and liabilities of $260 million as of June 30, court documents filed on Monday showed.
Tuesday, October 15, 2013
Quote of the day
А. Алехин: «Внутренняя убежденность, что из всякой неадекватной ситуации на шахматной доске можно выйти, придумав комбинационное решение, является очень серьезным недостатком».Monday, October 14, 2013
Sunday, October 13, 2013
Saturday, October 12, 2013
Targeted failure of the week. Post No 109 and 110. Vintafolide and stem cell business.
The idea with vintafolide is extremely sexy: From wiki: Vintafolide is a derivative of the anti-mitotic chemotherapy drug vinblastine[1] in which it is chemically linked to folic acid. Vintafolide was designed to deliver the toxic vinblastine group using folate targeting to cancer cells that overexpress the folic acid receptor.[2] Vintafolide is being studied for treatment of late-stage ovarian cancer and mid-stage non-small cell lung cancer.
And guess what? Failure... Why? The sexy theory is not enough for the drug to be effective or, in other words, the theory is not ontologically correct.
The same s..t is with stem cell business (and I guess it is the beginning ot the bubble burst): Osiris exits stem cell business, sells unit to Mesoblast in $100M deal
Friday, October 11, 2013
Thursday, October 10, 2013
Targeted failure of the week. Post 108. Iclusig
Ariad shares plunged as much as 77 percent to $4.00 in heavy trading -- their lowest in three years.
The company said it paused enrollment in the trials after it reviewed new data from a pivotal mid-stage trial testing the drug to treat two forms of blood cancer.
Wednesday, October 9, 2013
Tuesday, October 8, 2013
Antibiotics: How we will win the war against bacteria
A new scientific mantra:
https://www.youtube.com/watch?v=IJoJTY4nj5g
https://www.youtube.com/watch?v=IJoJTY4nj5g
Monday, October 7, 2013
Sunday, October 6, 2013
Saturday, October 5, 2013
Friday, October 4, 2013
Top Biotechs Set to Win in the War on Cancer - cancer is scared to death!
Tuesday saw the wrap up of the 2013 European Society of Medical Oncology (ESMO) conference in Amsterdam, which featured key data from several of the companies covered by the biotech analysts at UBS. While the UBS team came away from ESMO with a much clearer picture of the competitive positioning and clinical profiles for many of the drugs from companies under their coverage, on balance this year’s ESMO meeting was much less stock-moving event than in years past.
One thing from the conference was extremely evident. The biotech sector remains catalyst-rich for the remainder of 2013, with key data readouts at several upcoming conferences to impact shares. In a new research report, UBS highlights the top names in the biotechnology world making huge strides to bring an end to a disease that killed almost 600,000 people in the United States alone in 2012.
Fecal Transplant, Now in Pill Form. Shit of the day.
Do not try it at home? Gel caps containing concentrated fecal microbes stopped recurrent Clostridium difficile infection and were well-tolerated by recipients, researchers reported here.
Erection as a critical resource
Call it the anti-Viagra. It's not a product for the man who can't get the party started. It's for the man who ends the party too soon.Competition is heating up to treat premature ejaculation, or PE, which may afflict one-in-three men at some point in their lives—and not just when they're teenagers.
Promescent, an FDA-approved, over-the-counter spray to treat PE. The spray uses lidocaine to reduce sensitivity and allow for longer performance. It is absorbed quickly so as not to be transferred to sexual partners. From here: http://www.nbcnews.com/business/new-sex-drug-men-too-much-hurry-8C11329732
Thursday, October 3, 2013
The many - the better?
Three parents and a disease-free baby
The upside of having three genetic parents
The U.K. government will allow scientists to create babies using DNA from three different parents—a positive development, according to some researchers, for parents with mitochondrial diseases.
The controversial procedure—also called mitochondrial replacement—is possible through in vitro fertilization (IVF). Mitochondrial diseases like muscular dystrophy affect about one in 5,000 people worldwide, so only a very small group of people would be interested in such a procedure, Virginia Hughes writes in Popular Science. The procedure would "be performed at a few select clinics in the U.K. and will be carefully monitored...[a]nd if not safe, it will most likely be banned."
Wednesday, October 2, 2013
Tuesday, October 1, 2013
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