AMRN
Rx:12,451{vs10,850;+14.76%}Sector 12.42%
NRx:5,406{vs4,549;+18.84%}Sec 19.61%
Ref:7,045{vs6,301;+11.81%}Sec +8.26%
V TRx Mkt Sh:13.91% vs13.62% last week
V NRx Mkt Sh:15.50%vs15.60% last week
V Ref Mkt Sh:12.89%vs12.48%
MUY BUENOS DATOS
CTIC
Alguien sigue dentro? Bueno, por si acaso, ahí van las buenas noticias:
Pacritinib Phase 3 Study Shows Positive Results In Patient Reported Outcomes Measuring Quality Of Life In Patients With Myelofibrosis
Yo mismo ;) . Es un valor que últimamente ha cambiado muchos cromos, en el momento que CEDA un poco la presión vendedora y llegue una buena noticia, se puede ir para arriba. Gracias
Buenas,
Se pone interesante el tema de la primera enmienda. A ver que movimiento hace la FDA... se le está complicando la cosa.
Big Pharma Torches FDA In Amarin's Free Speech Suit
Share us on: By Jeff Overley
Law360, New York (June 11, 2015, 9:34 PM ET) -- The world’s largest drugmakers on Thursday attacked the U.S. Food and Drug Administration’s response to Amarin Pharma Inc.’s free speech challenge to limits on off-label promotion, telling a New York federal judge that the agency’s proposed leeway is far too modest.
The criticism was laid out in a pair of amicus briefs filed by trade group Pharmaceutical Research and Manufacturers of America and a prominent drugmaker coalition called the Medical Information Working Group. Those briefs shared a number of similar themes, including repeated assertions that FDA limits must be dialed back in light of recent landmark rulings from the Second Circuit in U.S. v. Caronia, which is binding in New York, and the U.S. Supreme Court in Sorrell v. IMS Health.
Moreover, the briefs were dismissive of a letter that the FDA filed last week in a seeming attempt to moot much of Amarin’s recently filed lawsuit. That letter declared that “virtually all of the communications” the Irish drugmaker wants to make about off-label uses of fish oil drug Vascepa are acceptable under existing regulatory guidance.
“FDA’s recent made-for-litigation ‘regulatory letter’ to Amarin does not cure the constitutional defects in FDA’s content-based restrictions on protected speech,” PhRMA asserted.
The MIWG echoed that point, contending that the letter “illustrates both the problem with FDA’s ad hoc approach to speech restrictions and the need for judicial review.”
Amarin, which has not commented publicly on the FDA’s letter, had no immediate reaction to the amicus briefs. But the entry of outside groups into the litigation is all but certain to raise the case’s already high profile.
Both briefs also zeroed in on a caveat in the FDA’s letter that said Amarin will be permitted to make certain statements because of an “unusual combination of circumstances,” including evolving science on fish oil, Vascepa’s positive safety profile and the company’s commitment to finish a clinical trial exploring Vascepa’s potential cardiovascular benefits. Experts previously told Law360 that the qualifier was likely to prove controversial, and that proved correct on Thursday.
“FDA thus creates a one-off discretionary exception, applicable to this case and nowhere else, precisely the type of case-by-case determination regarding the legality of speech that the First Amendment forbids,” PhRMA complained.
The MIWG offered a similar take, writing that “in other words, the letter confirms that FDA’s regulations would prohibit Amarin’s speech, but that FDA has chosen to permit some of the speech in a limited manner, as an exercise of enforcement discretion on which no other manufacturer may rely.”
PhRMA’s entry in particular called to mind a recent case, Solis v. Millennium, which also pitted the pharmaceutical industry against the federal government in a battle over free speech, but which now seems unlikely to produce a First Amendment ruling. In that matter, the parties debated whether truthful and nonmisleading off-label promotion can be used as evidence of other illicit activities, or if it instead is inseparable from protected speech, and PhRMA reprised the issue on Thursday.
“Speech can serve as evidence of intent or motive, but only when the criminal act is distinct from the speech,” the trade group said.
The MIWG includes Bayer Healthcare Pharmaceuticals Inc., Boehringer Ingelheim Pharmaceuticals Inc., Eli Lilly & Co., Genentech Inc., GlaxoSmithKline LLC, Johnson & Johnson, Novartis Pharmaceuticals Corp., Novo Nordisk Inc., Pfizer Inc. and Sanofi-Aventis U.S. LLC. In Thursday’s brief, the group noted that the FDA has been successful in derailing previous lawsuits like that filed by Amarin, and it expressed alarm that last week’s letter may produce the same result.
“It would appear that the government intends to rely on its eleventh-hour Amarin letter to evade judicial review here as well,” the MIWG said.
PhRMA is represented by Craig A. Stewart, Robert Weiner, Jeffrey Handwerker, R. Stanton Jones and Taylor M. Owings of Arnold & Porter LLP.
The MIWG is represented by Eamon P. Joyce, Joseph R. Guerra, Paul E. Kalb, Coleen Klasmeier and Erika Maley of Sidley Austin LLP and Joan McPhee, Justin Florence, Douglas H. Hallward-Driemeier, Alan R. Bennett and Kellie B. Combs of Ropes & Gray LLP.
Amarin is represented by Floyd Abrams, Joel Kurtzberg and Michael B. Weiss of Cahill Gordon & Reindel LLP.
The FDA is represented by Ellen Melissa London and Kerala Cowart of the U.S. Department of Justice.
The case is Amarin Pharma Inc. et al. v. U.S. Food and Drug Administration et al., case number 1:15-cv-03588, in the U.S. District Court for the Southern District of New York.
--Editing by Chris Yates.
http://www.law360.com/articles/667033/big-pharma-torches-fda-in-amarin-s-free-speech-suit
AMRN
NVAX
La OMS ha dicho hoy que la próxima semana podría haber una reunión de emergencia sobre el MERS.
http://www.straitstimes.com/news/asia/east-asia/story/who-hold-mers-emergency-meeting-next-week-20150612?
Espero que inviten a representantes del sindicato de camellos, al fin y al cabo les responsabilizan de todo esto del MERS.
Monton de docs sobre demandas con fecha de hoy
https://dl.dropboxusercontent.com/u/57678878/27-1.pdf
https://dl.dropboxusercontent.com/u/57678878/27-main.pdf
https://dl.dropboxusercontent.com/u/57678878/31-1.pdf
https://dl.dropboxusercontent.com/u/57678878/31-main.pdf
No he podido leer nada
830 shares en premarket y -10%
AMRN
BUENOS DIAS ....
otra farma calentita para el dia de hoy
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS)
2.54 +0.04 (1.60%)
Pre-market: 2.91 +0.37 (+14.57%)
Jun 12, 7:47AM EDT
OCAT
Una vez de vuelta al ordenador tras los lingotazos de ayer puntualizo la noticia: no es una emisión nueva de acciones, sino la concesión de bonificaciones y stock options a los empleados, así que no hay dilución.
Dado que la junta es el 22 de julio y que los accionistas están muy cabreados y que están diciendo que van a votar no en masa por los retrasos, estoy segurísima de que la cotización va a experimentar una subida al menos hasta los 7 pavos para persuadirlos de que voten que sí se merecen dicha compensación. Vamos, que recomiendo la entrada para sacar unos duros a corto plazo.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
