Farmas USA

Nvax grafico diario.

Ibb

Gild

Bay

p.s me da un poco de corte ocupar tanto espacio.

MSTX
Hola, El problema es si no hay OK de la FDA y se te va a $0.20 directamente el chicharro en cuestión. Veo que en tu análisis hablas de una probable fase 3 positiva antes de fin de mes. Eso es bastante optimista por tu parte. Suerte.

Imágenes que demuestran que los fetos se masturban dentro de sus madres
https://es.noticias.yahoo.com/im%C3%A1genes-que-demuestra-que-los-fetos-se-masturban-071749619.html

paper: In-utero gratification behavior in male fetus.
http://onlinelibrary.wiley.com/doi/10.1002/pd.4923/abstract

Se acabó el culebrón

Monsanto accepts Bayer takeover

US genetically modified seeds giant Monsanto has accepted a takeover offer from Germany's Bayer at $128 a share, the BBC has learned.

http://www.bbc.com/news/business-37361556

EXEL

Ésta a lo suyo, suma y sigue con buenas noticias

European Commission Approves CABOMETYX™ (cabozantinib) Tablets for the Treatment of Advanced Renal Cell Carcinoma Following VEGF-Targeted Therapy

– CABOMETYX is the first and only therapy approved in the European Union to demonstrate improved overall survival, progression-free survival and objective response rate in a large, randomized phase 3 trial of patients with advanced kidney cancer –
– Approval of CABOMETYX in European Union triggers $60 million milestone payment to Exelixis under licensing agreement with Ipsen –

http://www.exelixis.com/investors-media/press-releases?cpurl=http%3A%2F%2Fir.exelixis.com/phoenix.zhtml?c=120923%26p=irol-newsArticle%26ID=2201671%26highlight=

AMRN
Total Monthly Retail Data August-2016 + SunTrust Flash Note

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125142932

Sam81 Wednesday, 09/14/16 04:23:36 AM
Re: None
Post #92041 of 92042 Go
Total Monthly Retail Data August-2016 + SunTrust Flash Note

V
TRx: 78,534 {vs 70,792; +10.94%} – Sector +7.65% -- ATH
NRx: 30,981 {vs 27,348; +13.28%} – Sector +9.76% -- ATH

L
TRx: 9,879 {vs 9,326; +5.93%}
NRx: 3,739 {vs 3,675; +1.74%}

Gen L
TRx: 271,700 {vs 254,400; +6.80%}
NRx: 100,370 {vs 92,060; +9.03%}

Monthly Retail TRx Market Share: 21.81% vs 21.16% --- ATH
Monthly Retail NRx Market Share: 22.93% vs 22.22% --- ATH

SUNTRUST FLASH NOTE
As Expected, REDUCE-IT Continues as Planned
REDUCE-IT next interim look expected in mid-2017
REDUCE-IT CV Outcomes study to continue as planned

AMRN announced that the independent data monitoring committee (DMC) for its REDUCE-IT outcomes study completed its review of the first pre-specified interim efficacy. As we expected, the independent DMC recommended that the trial continue as planned without modification. As per the study protocol, the first interim efficacy analysis was conducted after attainment of ~60% of the total target 1,612 primary cardiovascular (CV) events, & in order for the trial to stop early, the results would have had to show a very highly statistically significant benefit vs. placebo (p < 0.0076), which we didn’t expect to occur. Amarin remains blinded to the interim analysis & ongoing results of the REDUCE-IT study until after the study is stopped at either the next interim analysis in mid-2017 or at the final analysis. AMRN expects REDUCE-IT to attain ~80% of total target events in the first half of 2017, with the second pre-specified interim efficacy analysis anticipated by mid-2017. The criteria for early stop at the 80% target is less rigorous than the 60% interim criteria (early stop at 80% is triggered if p < 0.022), but still materially more onerous than the p < 0.05 criterion required for statistical significance. As such, we expect the DMC to recommend that REDUCE-IT continues until attainment of 100% of the target 1,612 primary events, which is estimated to occur in 2017, yielding publication of results in 2018. The REDUCE-IT trial design is modeled after nine previous outcomes trials for statins. We believe that Amarin will showcase the REDUCE-IT trial design in a peer-reviewed scientific journal [possibly the New England Journal of Medicine (NEJM)] in the near-term. AMRN indicated in its 2Q16 earnings call that the timing of the publication depends on the trial’s Principal Investigators & journal peer review. The REDUCE-IT trial is an important catalyst for AMRN, since it could contribute to meaningful expansion of the Vascepa label and commercial opportunity in patients with elevated triglycerides treated with statins. We see upside to our Vascepa 2016E sales estimate of $120M vs. Street’s $120M.

Vascepa TRx trends point to upside to our 3Q16E/2016E estimates
Our analysis of Vascepa TRx/NRx trends as reported by IMS Health (IMS, $29.86, Neutral, Sandy Draper) leads us to believe there is upside to our 3Q16E revenue estimate of $30.0M (+41% YoY). As of 9/2/2016, rolling 4- week adjusted TRx’s are ~69K, up +55% YoY, with TRx’s & NRx’s up in high 40% to low 60% range (YoY) since the beginning of 3Q16 as ANCHOR & JELIS promotions continue to volume growth. The robust Vascepa volume trends, along with the +6% price increase taken by AMRN at YE15, point to upside to our 3Q16 revenue estimate ($30M, +41% YoY). If these positive trends persist in 2H16, they could place upward pressure on AMRN’s $112M - $125M net product revenue projection for full-year 2016 (we model $120M in FY16 Vascepa revenue, above AMRN’s mid-point and in-line with the Street net product estimate).

NVAX

Top 40 drugs in Chemical & Engineering News supplement. Sept 2016.

Página 18

http://cen.acs.org/content/dam/cen/supplements/09435-cens-web.pdf

Respiratory syncytial virus (RSV) is widespread, and
virtually every child will be infected with the virus by
the age of 2. Early in life, the virus can be a menace
rather than a nuisance, causing inflammation of the airways
and pneumonia—and in some cases, death. “It is the most
common single reason for hospitalization of infants in my
hospital and most hospitals in the US,” says Janet Englund, a
specialist in pediatric infectious disease at Seattle Children’s
Hospital.
In the 1960s, an effort to inoculate infants against RSV ended
tragically, with two deaths and numerous hospitalizations—an
outcome that Englund describes as a major setback to RSV
vaccine-development efforts. As an alternative, Novavax is attempting
to protect babies by vaccinating mothers during pregnancy.
Newborns lack the ability to mount an immune response
of their own, but are protected at birth by antibodies acquired
from their mothers from the late second trimester onward. “We
know that naturally-occurring antibodies go across the placenta
quite well, and we think vaccines should work similarly,” says
Englund. Indeed, maternal vaccination against diseases like
influenza, pertussis, and diphtheria has proven safe and effective
enough to win the support of leading health organizations
like the CDC.
These are all conventional vaccines that are being administered
to moms off-label, but Novavax is gunning for RSV-F to
become the first vaccine to achieve licensure specifically for use
in pregnant women. A Phase II trial showed that their formulation,
which is based on a well-conserved viral surface protein,
elicited a strong immune response in mothers-to-be relative
to placebo, with generally mild and localized adverse events.
Critically, these antibodies were also readily detectable in newborns,
at a level that could confer protection against infection
for months after birth.
RSV is a global problem, and this vaccine program is being
backed in part by $89 million from the Gates Foundation as it
moves forward with Phase III testing. The vaccine is also being
assessed in a separate trial for the elderly, who are vulnerable
to RSV, and has been awarded a Fast Track designation by
the FDA for this population. The road to licensure is still not
defined for maternal vaccines, but Englund notes that the FDA
has been proactive in trying to establish a clear path for such
programs.
There are some caveats to the maternal vaccination approach.
Since antibody transfer peaks in the third trimester,
prematurely-born children would not necessarily be protected.
Furthermore, maternal antibodies dwindle over time, largely
disappearing by four months of age. “But since the peak hospitalization
for RSV occurs at two months, that would still potentially
help,” says Englund. “It’s not going to get rid of it, but it will
certainly help.”

NVAX

13 SEP.
ob: Associate I, Tech Transfer

Responsibilities include but are not limited to:

• Manage experimental plans, sampling plans, sample coordination and data collation and analysis.
• Verify that the samples received are aligned with the sampling plan developed for the designed study.
• Aliquot samples according to the sampling plan.
• Submit samples to testing groups according to the testing plan developed for the designed study.
• Organize and store sample retains in designated storage area. Maintain record of stored materials.
• Track and trend data and communicate to stakeholders
• Create and implement process improvements to manufacturing and business processes
• Other projects as assigned by management.