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Thanks for the update.
I asume the implantable pump has a no-delivery alarm, as well as a backup delivery system to ensure the drug is given without any interruptions. I see Medtronic is testing its own pump for the indication:
http://clinicaltrials.gov/ct2/show/NCT01321073
I think ß-secretase inhibitors therapies will face similar challenges to those seen with y-secretase (because the enzyme has many substrates* and a wide substrate binding domain) I'd expect serious off-target tox.
*like neuregulin-1, which is involved in myelination and y-secretase inhibitors have in fact shown AE on myelin in animal models.
There are TauRx with their tau aggregation inhibitor (formulated of methylene blue) and Noscira with an inhibitor of tau phosphorylation. Think both in phase II (not following closely), but I don't have high hopes here. Thing about tau is figuring out how to target it and I think it will take few more years before tau based therapies will take off.
Not many reasons to start a patient on the NNRTI with the higher rate of virologic failure.
Teva has 9.6% in Bioline and is the biggest among the controlling shareholders. Teva's strong man - Dr. Schwartz is the Chairman of the BOD and is quite active. On valuation: in general, local market usually gives low valuation to biotech comp. MC was a lot higher before Bioline announced partnering BL-1020. Investors here were very disappointed and the elevated risk plus the need to raise more cash is holding the stock.
Derek Lowe:
Teva is not alone here; Tysabri's price was hiked by 7% on Dec. and by 19% in June 2010. Looks like Gilenya's annual price at $48K gave a push to other MS drugs' pricing .
One thing I like about BiolineRx is they have an anti 'Zebra's law' policy and they tend to kill projects at the first slip and early in development not wasting resources. The other less famous but interesting and promising thing in their pipeline for now is IK-5001 (a.k.a BL-1040):
http://clinicaltrials.gov/show/NCT01226563
Dr. Reisa Sperling also said on amyloid related imaging abnormalities (ARIAs i.e. vasogenic edema), that she considered the new findings* to be positive for bapineuzumab's future prospects.
*Sperling R, et al., Salloway S, et al.
[OT]Haven't heard the word 'dreck' since my grandparents passed and there's a lot more of it in my country nowadays
Indeed. And never trust secform4.com or yahoo for accurate insider transactions.
On the "Height and cancer incidence in the Million Women Study"
I don't like nor read too much into association studies of this type but when you wrote:
No need to apologize. Amgen has several unexpired G-CSF PEGylation patents in the US 5,824,778, US 5,824,784 (the one you've found), US 6,166,183. From a quick look i suspect they only cover PEGylation when PEG molecule is attached to any amino acid via a carboxyl group at the N-terminus of the protein. Ratiopharm uses a different PEGylation method. See also #msg-65405618
In other words (my nitpick), Neugranin does not infringe on AMGN’s methods for PEGylating G-CSF patents, but it does infringe on AMGN’s G-CSF protein sequences patents.
I believe that lipegfilgrastim, the Neulasta knockoff from Ratiopharm, also has the same amino acid sequence protected by Amgen's IP and might (haven't looked deep into the methods for PEGylating G-CSF patents and not sure if linking the peg polymer to carbohydrate (glycan) is covered by those) face another hurdle with the PEGylating G-CSF patents that are running till 2015. Your point that lipegfilgrastim was not included in the settlement and the above makes me think it will not be launched in the US at least before patents expiration.
How about Mycograb? sounds similar enough to be confused with Mylotarg?
No, i think the name Acomplia was rejected because it sounded similar to another drug and the FDA was afraid of confusion.
The FDA rejected the brand name Omnitarg for Pertuzumab because its phonetic sound implies the drug has some unique effectiveness i.e. all/many targets, and it's misleading.
At the moment, lacking full data from CARE-MS1 trial and awaiting CARE-MS2 trial results, Lemtrada potential place in the MS arena looks at a distant behind Tysabri, Gilenya, and BG12.
The 55% reduction in relapse rate compared to Rebif® over the two years of the study (p<0.0001) is not as good as the 74% rate after 3 years from phase II trial*, where it was also found to reduce the risk of sustained accumulation of disability by 71% (P<0.001 for both). Safety, on the other hand was better.
* Ref: http://www.nejm.org/doi/full/10.1056/NEJMoa0802670
Think the FDA will probably ask for another trial in that subset. Another question/problem is what will it take to find early AD patients - PIB brain imaging? CSF phoshpo-Tau levels? these tests carry logistic and economic implications.
I'm sure data will also be analyzed by AD severity at start, as treating mild patients is expected to be more efficient than treating more advanced ones. Question is do they have enough mild patients in the trial to see a stat-sig effect in this group.
You're right on the terminology. What I meant is that by testing all those 3 combos VRUS makes the odds that its nuke(s) will be part of future all-oral DAA treatment very high.