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Only not 'so perfect' thing is in PEARL-IV GT1a "Virologic relapse or breakthrough was noted in 8 percent of patients receiving the regimen without ribavirin and 2 percent of patients receiving the regimen with ribavirin."
If I were MNTA or MYL I would first want to see the FDA approves the 20mg and then how well the generic version sells.
Exactly.
(nice to see you have been reading the whole PR and even remembered the content )
Thanks, the 2% discount is mentioned here as well:
http://www.biocentury.com/dailynews/company/2014-01-29/teva-prices-thrice-weekly-copaxone
Too small discount to encourage patient conversion, guess the main strategy is statments like the one made by Prof. Khan.
Re: FDA approves thrice weekly Copaxone
At least this came out as they expected...
Didn't say anything on pricing but they still think they can switch large part of patients (30-40% until May and even 45% in 6 months).
I thought that selective modulators of PPAR gamma phosphorylation would be the next stage in development (see this work from Merck for example):
http://molpharm.aspetjournals.org/content/early/2012/04/11/mol.111.076679.full.pdf
But Daiichi dumped its agent recently after reviewing its clinical studies results and I cannot see others that look viable.
I think GT1 patients will need to wait less than a year for Sovaldi/ledipasvir pill (GILD said U.S. NDA submission planned for Q1 2014 and it should be on the market before year end).
Ratiopharm did look like a good strategic move but didn't match expectations (to say the least) because shortly after the acquisition pricing changed and there was a serious slow down in their business.
Barr acquisition was bad and so were Ratiopharm and Bentley. In addition to those you've mentioned Taiyo was also a fine acquisition.
Cephalon was the worst.
Teva buying plans
Strategy when Levin was in charge was to focus on CNS and respiratory and to a lesser degree on oncology and women health and no more big acquisitions. It is still unclear what the strategy of the new CEO, who doesn't really have operating experience in the pharmaceutical industry would be. I just hope Teva under his leadership won't make terrible acquisitions as before.
PSTI
Phase I/II trial in the treatment of muscle injury met primary safety & efficacy endpoints:
http://maya.tase.co.il/bursa/report.asp?report_cd=874084-00&CompCd=1569&Type=Pdf
Better success rates come with a price and getting more personalized is complex and expensive, but in the long run I believe it will pay because trials success rates will rise, and trials will be more targeted and less expensive to conduct, and medicine will become much more effective.
My thinking of personalized medicine is for example adoptive immunotherapy (using autologous T cells genetically engineered to express a receptor against an antigen specific for a certain tumor), which looks quite real nowadays. Since it's nearly the weekend here's an 18 min TEDMED talk describing a fascinating different approach, that still seems like science fiction but I can certainly see this happen because this guy is not only very talented, he is also a doer:
On oncology drugs failure rate - I'm probably stating the obvious but I believe that the more personalized we get with cancer, the better success rates we see in both drug development and treatment outcome.
.
Derek Lowe on this paper from Nature Biotechnology:
Clinical development success rates for investigational drugs
http://pipeline.corante.com/archives/2014/01/10/a_new_look_at_clinical_attrition.php
The original paper:
http://www.ncbi.nlm.nih.gov/pubmed/24406927
Merck never gave information on MK-7622 MOA. Could be M1 muscarinic receptor positive allosteric modulator:
http://link.springer.com/article/10.1007%2Fs00213-012-2788-8
We are used to Teva's assertions but now at least they back this one with basic science data. Quite sure the data refer to the glatimer acetate Natco is selling in India, and as you noted, we don't know if it's the same formulation Mylan/Natco submitted to the FDA.
Teva's way to object Natco's generic Copaxone:
http://maya.tase.co.il/bursa/report.asp?report_cd=872381-00&CompCd=629&Type=Pdf
Are you a PPHM fan or do you simply like phosphatidylserine?
Re: Interim phase-2 data on VX-135 + Daclatasvir
It simply looks like VX-135 doesn't have what it takes for a component in a combo to compete with what GILD and ABBV have.
Chimaeric antigen receptor (CAR) therapy vs. T-cell receptor(TCR)
OPLI
Phase III of CF101 for Dry Eye Syndrome failed:
http://finance.yahoo.com/news/ophthalix-announces-top-line-results-063000733.html
CANF/CF101 better potential market uptake in psoriasis than in RA
CANF
Both CF101 and Apremilast have inferior efficacy vs anti-TNFs and JAKs and looks comparable to me at this point with available data, but Apremilast has more AEs.
CANF
One more point is the data we've seen today are from 12 weeks treatment and efficacy tends to get better at 24 weeks. Anyway, I don't see the drug competing with anti-TNFs or even JAK inhibitors, but as monotherapy alternative to methotrexate, in patients who have failed or are refractory to methotrexate or cannot tolerate it (CF101 has a much better safety profile).
There's also an interesting and perhaps appealing point in the fact the drug has a biomarker (A3AR expression levels) that predicts the response.
Glad you survived the storm
Midas asked me to answer your question on Can:
Insiders own 13.18% (the light blue area in the pie chart diagram), and the rest - 86.82% by the public.
You can find all info in English here:
http://www.tase.co.il/Eng/General/Company/Pages/companyDetails.aspx?CompanyId=001272&ShareID=01126267&subDataType=3&IsOpen=1
GIVN - the deal:
http://maya.tase.co.il/bursa/report.asp?report_cd=862515
GIVN - the buyer is according to rumors Covidien and the price $955M or $30/share.
Am I that obvious?
GIVN—That's why I said in a former post that the market for it in Japan could be bigger than in the US.
GIVN PillCam Colon2 in Japan
It is indicated for diagnosis of colonic disease when a colonoscopy is required but difficult to conduct including for patients unwilling or unable to undergo colonoscopy, a broader language than the intended label in the US. Btw, in Japan fecal occult blood test is recomended at the age of 40 and north.
Fuji was mentioned before as a possible bidder. GIVN has good relations with them for many years and had mutual R&D projects, they sell the SB pill through Fuji and talking about PillCamColon 2 plus the market for it in Japan could be bigger than in the US.