Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Paragraph IV filed in 2008 against the 2019 US patents not the 2015 COM patent, so clearly a final approval will only occur after expiration of the 2015 patent.
On a side note, Novartis is conducting a long litigation in India where Gleevec was not granted patent protection (total different situation there. For more readings: http://www.economist.com/node/21562226 ), but no suit against Sun Pharma in the US yet.
Novartis has guided in recent calls that the base patent (I would presume the composition of matter patent, but I haven't really looked into it) for Gleevec expires in the US in late 2015.
However, they also have a variety of patents on other isoforms/polymorphs/crstalline formulations that they will try to use to defend against generics beyond the base patent expiry.
I don't believe in magic pills, and it is quite clear that in order to maintain a 'normal' weight in the long run one must change his/her lifestyle. But I think these people need all the help they can get including counselling and pills and it should be supported by the government, imo.
Edit:
(I replied before you've changed your post)
It is a bit different here because obesity isn't epidemic yet in Israel.
What you are missing is the HUGE tendency in the US to view obesity as a moral problem (sloth and gluttony). And it is immoral to mitigate the 'natural punishment' resulting from a moral problem.
VVUS:
I had the impression that obesity is already recognized to be a national epidemic and a major contributor to some of the leading causes of death in the U.S. and as such I thought that the government would have push for reimbursement of anti obesity drugs.
The Pradaxa label was revised and updated several times as seen in the first link you've posted "Label and Approval History". Your secound link is indeed the most recent update (Revised: 11/2012), after FDA’s study of the bleeding issue. My reply to Clark points to an earlier revision and update on the need to assess and monitor renal function and lower dose if required.
VVUS
Just 1 in 5 patients get reimbursement
They can be really confusing these Dr. types
BMRN
Well, they were smart to go with the 6MWD. The bone growth can be shown in a post marketing trial. Indeed it's more than a skeletal disease, damage to many organs (heart, eyes, ears, lungs, GI) and no doubt that the sooner you start ERT to restore deficiency in the enzyme is better and treatment is needed for lifetime.
wondering if the nature of the disease where drug is needed most its harder to get into those cells.
having a large sample size certainly helped here
Naglazyme didn't hit on 6MW
Amicus NJ Facility and Operations Intact and Fully Functional
the data (perhaps it exists and I missed it) comparing patients with a high ability to control INR vs Eliquis
the data about benefit and risks vs warfarin after start up.
TEVA:
Bill Marth is stepping down immediately and will stay on as an advisor through 2013 until he officially retires.
the FDA analysis of the Pradaxa data indicates with some moderately high confidence that the increased bleeding that happens with Pradaxa as patients get older is largely independent of renal function.
The only bug is this part " Patients dosed with GALNS at 2 mg/kg every other week did not show a meaningful or statistically significant change from baseline compared to placebo. " but since the weekly infusions arm was stat-sig with p=0.0174 plus secondary endpoints, I think approval is highly likely.
Point about age and new anti coagulation agents
Since the majority of atrial fib patients are over 70 and therefore are at risk for renal dysfunction, Eliquis will have an advantage as it has lower renal excretion percentage than both Pradaxa and Xarelto.
BMRN
GALNS phase III in Morquio met its primary and secondary endpoints.
Quite clear to me that the NYT article is about making a headline and therefore is emphasizing the side of the story that serves its target by telling the sad cases of patients who "bled to death" without giving all the details (were there other bleeding risk factors such as decreased renal function, low body weight, other concomitant medications that interact with Pradaxa like amiodarone, quinidine or verapamil etc), nor highlighting Pradaxa's advantages.
Eliquis will probably have superior safety and efficacy over coumadin claim in its label so its advantages are better understood.
Of course an antidote will make docs/patients feel a lot more comfortable with factor Xa inhibitors drug class, although in reality it would be used very rarely.
Seems that Gilenya share comes a lot more at the expense of the beta interferon class than of Copaxone and Tysabri.
MS drug pricing
I think BIIB would be wise to price BG-12 below Gilenya and above Copaxone.
Copaxone is still holding more than 40% of MS drugs market share.
Hard to see if and how GILD will be able to show TAF and its new combo pill are different from Viread's combo - Stribild and will the (possible) difference in efficacy and or safety would be enough when Viread goes generic.
TauRx AD program
NFT formation and load correlate with cognitive decline and progression of AD and tau aggregates are believed to cause toxicity to neurons plus Wischik showed some very promising results for Rember in slowing disease progression in phase II, but data was not without weakness and Wischik didn't published a lot of data and somehow I get the feeling he only presents what he wants. So if the effect Wischik showed was real - I don't know, but if it holds up then the headlines he made since 2008 are not at all presumptuous.
At least blinding is real this time
The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding
Sounds like the beta amyloid biomarker results showed a trend in favor of Solanezumab but
There were no changes noted in other AD biomarkers such as tau, phosphorylated tau, hippocampal
volume, whole brain volume, or amyloid accumulation measured by PET imaging.
What is the world’s second-largest-selling ophthalmic drug? (Lucentis is the largest.)
LLY
TUESDAY, OCTOBER 30TH Symposium 5 : Solanezumab Phase 3 results: Implications for Alzheimer's disease modification
Eric Siemers, MD, Eli Lilly, USA
http://www.ctad.fr/02-program/prog-2012/tuesday.asp#ancre11
UTHR: Although bringing oral remodulin to the market seems more challenging now after the CRL, sounds like Dr Rothblatt insists on doing so. In addition to the problems you've mentioned, wouldn't an oral remodulin hurt Tyvaso market share if approved?
UTHR is already conducting another oral remodulin trial that started enrolling a few months ago:
http://clinicaltrials.gov/ct2/show/NCT01560624?term=NCT01560624&rank=1
It has 2 primary endpoints: "Time to First Clinical Worsening event" and "Change in 6 minute walk distance", but no "fixed dose design" nor "more frequent dosing"...
Just to be clear, what I meant to say was that the faster track to market story shouldn't be the main reason to like PSTI.
I assume this piece triggered your question:
http://www.globes.co.il/serveen/globes/docview.asp?did=1000791112&fid=1725
Of course, a faster and cheaper clinical path would be good for any drug developing company, but note that Dr. Hamburg said the agency is considering a faster track for drugs with "special medical use" label. Don't know when a guideline will be issued and if one of PSTI's treatments qualifies at all.
I was going to vote after October the 29th (#msg-80358924).
Why a separate board?
I know and respect Pnina Fishman, fwiw.
If it were up to Humi he would never sell under $30 but the guys upstairs, i don't trust them.
If i believe in my own target why sell now?
Serious: sold 3/4 at over $18
I was thinking of you earlier #msg-80655599
Don't know about your price target, $24 might be too high. If you bought in Aug at high $12 why not sell now?
GIVN is out of my watch list after this announcement.
(Hope Dubi enjoyed the bounce in the share price)
ABT’s all-oral phase-3 trial in HCV:
They said they use ritonavir at a much lower dose so presumably less tolerability issues from this one.
http://seekingalpha.com/article/930191-abbott-laboratories-management-discusses-q3-2012-results-earnings-call-transcript
ABT announced initiation of phase III program for all-oral HCV in GT1
http://www.abbott.com/news-media/press-releases/abbott-reports-double-digit-earnings-per-share-growth-in-the-third-quarter.htm
ISIS
There were also questions on preclinical malignancy signals (fibrosarcoma, hemangiosarcomas, and
hepatocellular adenomas/carcinomas), which were "Mipomersen-related tumors were all seen at clinically relevant exposures".