Novartis AG (NVS)
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- Replacement Candidates for David Merkel's Portfolio: From AA to ZZ [view article]
- Big Pharma Pipeline: Why So Dry? [view article]
- Largest Companies in the World [view article]
- Time to Invest in Pharmaceuticals? [view article]
- Companies With Recent, Innovative Product Approvals vs. Healthcare ETFs [view article]
- Novartis Example: Why Drug Discovery / Development Is Hard [view article]
- Big Pharma’s Healthy Appetite for Acquisitions [view article]
- Like a Fine Watch, a Swiss Fund [view article]
- Oncology Conference Countdown: What Will Pharma and Biotech Companies Report? [view article]
- When Greenspan Talks - Fast Money Recap (7/31/08) [view article]
- They All Fall Dow - Fast Money Recap (6/2/08) [view article]
- Wall Street Breakfast: Must-Know News [view article]
Recent NVS Articles
- Big Pharma Pipeline: Why So Dry?
- Largest Companies in the World
- Time to Invest in Pharmaceuticals?
- Novartis Example: Why Drug Discovery / Development Is Hard
- Companies With Recent, Innovative Product Approvals vs. Healthcare ETFs
- Big Pharma’s Healthy Appetite for Acquisitions
- Like a Fine Watch, a Swiss Fund
- KV Pharmaceutical's Motion for Rule 11 Sanctions in Ritalin LA Case Denied
- When Greenspan Talks - Fast Money Recap (7/31/08)
- Amgen's Big Win - Fast Money Recap (7/25/08)
- Full List of Articles »
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Wall Street Breakfast: Must-Know News [view article]
A good survey of the morning's news. I have come to relie on it. ReplyWall Street Breakfast: Must-Know News [view article]
is mazel tov related of rabbi hoffman ReplyWall Street Breakfast: Must-Know News [view article]
Mazel Tov Rabbi Hoffmann ReplyAccessories
Wall Street Breakfast: Must-Know News [view article]
Good Stuff ReplyThey All Fall Dow - Fast Money Recap (6/2/08) [view article]
Thanks, ReplyThree Game-Changers For Big Pharma [view article]
It is sad the FDA has lost focus on it mission: bringing safe new medicines to patients. ReplyLepoff, M.D.
Oncology Conference Countdown: What Will Pharma and Biotech Companies Report? [view article]
Very interesting. Thanks for the info. ReplyOncology Conference Countdown: What Will Pharma and Biotech Companies Report? [view article]
Hi Mike, great article and idea for investors of biotech and pharma oncology stocks. We know big pharma has been looking at small biotechs with promising cancer vaccines. Looks like this one of a Phase I study I found from ASCO 2008 is not only safe (no grade 3 toxicity cases), but is the first peptide vaccine to exhibit such positive immuno responses even WITHOUT an adjuvant:Results of the first phase I clinical trial of the novel Ii-key hybrid preventive HER2/neu peptide (AE37) vaccine: United States Military Cancer Institute Clinical Trials Group Study I-03.
Sub-category: Vaccines
Category: Developmental Therapeutics: Immunotherapy
Meeting: 2008 ASCO Annual Meeting
"Results: All 15 patients completed the trial with no grade 3-5 local or systemic toxicities. Dose reductions occurred in 47% of patients for local reactions >100mm or grade 2 systemic toxicities. The second group (peptide=500mcg, GM-CSF=250mcg) all required dose reductions prompting peptide-only inoculations in the third group (peptide=1,000mcg, GM-CSF=0mcg). AE37, with and without GM-CSF, elicited dose-dependent immunologic responses in vitro and in vivo to both AE37 and AE36 albeit AE37 responses were more robust. Assessing both toxicities and immunologic responses, the hypothesized optimal biologic dose was determined as peptide=500mcg, GM-CSF=62.5mcg, in 6 monthly injections. Conclusions: The hybrid AE37 vaccine appears safe and well tolerated with minimal local or systemic toxicity if properly dosed. AE37 is capable of eliciting HER2/neu-specific immune responses, even without the use of an adjuvant.
This trial represents the first human experience with the Ii-Key modification, and to our knowledge, AE37 is the first peptide-based cancer vaccine to show potency in the absence of an immunoadjuvant."
www.abstract.asco.org/...
AE37 vaccine is from Antigen Express- a wholly owned subsidary of (GNBT) Generex. This is now in a large Phase II with the USMCI. What do you think?
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Three Game-Changers For Big Pharma [view article]
The author is incorrect in stating that Amgen will have to conduct a fracture study (instead of simply relying on BMD) for Denosumab due to the Vytorin. Fracture studies are the standard in phase III osteoporosis studies. Look at the FDA guidance document:www.fda.gov/CDER/GUIDA...
Also, look at Novartis' Reclast that also had fracture in its studies:
www.bio-medicine.org/m.../
Finally, Denosumab is not a me-too drug. It is an antibody - not a bisphosphonate. Reply
fan
Former Merck CEO Prods Industry on Drug Pricing [view article]
Dr. Vagelos points the finger at Genentech for charging "unsustainable&qu... prices for a cancer drug that is utilized by mere thousands of patients rather than the millions of patients Merck's statin drug is sold to. As a result, Merck only has to charge each patient several hundred dollars a month to earn 2-3 times the revenue that Genentech earns from Avastin. Perhaps Dr. Vagelos would have only drug companies in business that research and discover only "mainstream" drugs for the masses (that mediate pain but also cause heart attacks) and not the lifesaving drugs like Herceptin for breast cancer that has saved thousand of women's lives. Dr. Vagelos conveniently forgot to point out that Merck has reaped tens of billions more in revenue from the same system that he says can't sustain the cost of Avastin. ReplyStudent
Aegerion Pharmaceuticals: Capitalize on Cholesterol [view article]
I do not have much optimism for this drug candidate. It is as some of you put it" a me too" type drug with obvious approval hurdles from the increased lipid content of hepatic tissue, further reinforced by the FDA's recent letter to Isis Pharmaceuticals raising the bar for approval of their Mipomersen candidate for the same indications. However, Mipomersen has several advantages over AEGR-733.1st its a novel and unique Mechanism of Action using antisense RNA strands to reduce the expression of vital components of highly atherogenic LDL protein components targeting the problem at the SOURCE, NOT at a downstream stage in the pathway.
BUY ISIS forget this junk stock, Im shorting it tomorrow. Reply
Former Merck CEO Prods Industry on Drug Pricing [view article]
I'm not arguing for or againt lower prices. I just want to point out something.We live in a country whose economy is more market oriented than centrally run (govt) oriented. As a result, you have for profit companies in the pharma industry. The reason to incorporate is to make money. Period. That's the one responsibility a "company" has to abide by. As long as medicine continues to be a for profit business then the way it is will continue ad infinitum. Putting restrictions on profit motive will make future investment (R&D) more expensive relative to future profit. Ultimately, This means that their are some drug candidates that are not as risk free in developing and these will be the ones not pursued. Breakthroughs wont stop, but they will come at a much slower pace.
Personally, I think people are having an argument over the wrong question/issue. It's not about legislating the prices that companies can charge. It's about whether pharma should be allowed to be for profit companies. Non-profits could still invest for R&D as current Co's do and still charge less because they don't need to make all these billions of dollars of profits every year. Reply
Former Merck CEO Prods Industry on Drug Pricing [view article]
With the direction the medical care and the pharmaceutical industry is going, reevaluating its moral stand and humanitarian role is an absolute must. Nowadays it is more and more questionable why are these industries still allowed to be “for profit” establishments.Profiteering based on people’s health-sickness and life-death matters are not just completely unacceptable and a total shame; it’s plain wrong. Yet, this is exactly what is going on. It is only a matter of time, until the society will turn against such profiteering and hopefully governments will follow suite. Today, seeing the deluge of medication ads (mostly for prescription drugs) on the TV is disturbing. Why hasn’t that been banned yet? All those loopholes need to be closed! Now! This is a huge sign that profiteering and not humanitarian reasons are driving the industry’s development; that has to change.
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Sucampo and Takeda's Newly Approved IBS Drug Is Sexy To Investors [view article]
Seems Japan companies seldomly bring the world a blockbuster even when the medicine has the potential.Too many constraints on marketing expense, is this the reason? Reply
Esperion Spin-Off: Does It Signal the Start of a New R&D Era? [view article]
Another downside could be the loss of potential synergies of medicines. I heard of that new imitrex follow up that contained ibuprofin too I think. It was a way to bring imitrex from the metaphorical economic death that is generics. If you have other drugs that are patented that can be mixed to enhance effects before one of the patents are lifted then you can use that to enhance earnings. Divesting all your bases of drugs combinations reduces possible synergies Reply