Farmas USA

For Zohydro, the FDA determined that additional large-scale efficacy or safety type trials were not required for approval. Zohydro was required to prove that the drug release profile was unchanged by the addition of the third bead. This required a much smaller set of data from Zogenix to verify that the efficacy and pharmacokinetic profile of the old formulation was met by the new formulation. These were bench type/size studies, which did not take long to complete, but were needed to ensure the original drug profile remained the same.

Zohydro also has ongoing Human Abuse Liability studies, which are required in order to be categorized by the FDA as abuse-deterrent. Since Zohydro can still be dose-dumped orally by crushing the capsule, it will be interesting to see what happens. Zogenix also has an agreement with Teva Pharmaceutical (NYSE:TEVA) for the right to reference carcinogenicity data for its pending NDA for extended-release hydrocodone.

http://seekingalpha.com/article/2891086-zogenix-approval-sheds-light-on-path-for-elite-pharmaceuticals?ifp=0

 Institutional Holdings: 63.39% 

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OCAT

Presentación ayer en la que surgieron nuevos datos importantes que no están recogidos en el Lancet de dos nuevos pacientes y formación de tejido. Se dijo que hay prevista otra nueva publicación "pronto". Son muy buenas noticias. La transcripción del cacho:

"72% of our patients have visible pigmentation and this patient actually was not actually published in the paper, so once we showed safety the FDA said ok, you can transplant in less severely ill patients. This patient started out with 20/150 vision and we transplanted them and within 6 months the transition zone looks more pigmented, but there is also some tissue right in the center of the retina, the center of the atrophy and here there is even more and if you look at the OCT and, Brandon, I'd be interested in what you think. But (referring to a slide) here you have no RPE, the RPE here ends, here at six months, you have a new sheet of RPE, at least it sure looks like RPE and the retina is changing a little. One year it is changing a little more and maybe some more remodeling. This is going over to a reading center. I am way too biased to make these calls but if you look at this here (again pointing to a slide) to me it looks like a sheet of RPE."

Corrección INSTITUCIONALES, he comprobado en Morningstar y se incluye el indice NYSE ARCA BIOTECH con lo que considero que es el registro mas actualizado hasta la fecha. Tambien he comprobado si en Nasdaq.com aparece el ultimo cambio de "Bellevue Asset Management AG" y no es así . Asi que creo que es mas fiable el registro de institucionales de morningstar.

Que es:

43,02 % de Institucionales

25,77% de fondos

2,25% de Insiders

TOTAL: 71%

Por cierto, a fecha 5 de Febrero 2015 tenemos que First Trust NYSE Arca Biotech ETF posee 12,22 millones de acciones.

Sin embargo, los 8 millones de acciones que sabemos que añadieron los de BlackRock en Q4 2014, no esta registrado con lo que aun queda mas por subir.

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Mira a ver que la bolsa israelí abre los domingos. Alguna farma hay por ahí

XOMA

Alguien la sigue? Su pipeline es espectacular y parece que hace suelo tras una larga caída. Alguien sabe el porqué de esa caída? Veo una dilución y poco mas.

http://www.xoma.com/content/pipeline/overview.htm

Mirad la sangría de ayer en FBT
http://finance.yahoo.com/quotes/CPHD,BIIB,PCYC,ICPT,NVAX,ILMN,SGEN,CRL,Q,GRFS,INCY,EXAS,UTHR,REGN,ALKS,CELG,ALXN,TECH,GILD,CLDX,PDLI,AMGN,QGEN,BMRN,MDVN,NKTR,ALNY,VRTX,ISIS,MYGN?

http://www.ftportfolios.com/Retail/Etf/EtfHoldings.aspx?Ticker=FBT

Como una moto, framus:))
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