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Farmas USA

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#24865

Re: Farmas USA

El artículo es un poco sensacionalista porque empieza el rollo de los tumores cuando, en realidad, fueron en ratas y están descartados en humanos. La FDA la ha aprobado y punto, y apuesto a que la EMA también lo hará. Los problemas aquí vienen de que el producto coloca, así que hay que adaptarse a una normativa de comercialización y demás. A todo esto, no hay que olvidar que los productos adelgazantes tienen una larga tradición anfetamínica. Si coloca, igual se vende aún más. :)

El problema es el tiempo y lo que ello puede afectar a la cotización.

Aquí están los datos que he encontrado

Lorcaserin ((R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzepine
hydrochloride hemihydrate) is a new chemical entity which has central
nervous system hallucinogenic properties. Lorcaserin is a serotonin
receptor agonist, at the 5HT2C and 5HT2A receptor
subtypes. Lorcaserin was approved by the Food and Drug Administration
(FDA) on June 27, 2012, as an addition to a reduced-calorie diet and
exercise, for chronic weight

HHS described a human abuse potential study in recreational drug
abusers of psychedelic drugs and CNS depressants, in which lorcaserin
and the comparator drugs zolpidem (Schedule IV) and ketamine (Schedule
III) produced significant increases on positive subjective measures
(visual analog scales (VAS)) for ``high'' and ``good drug effects as
well as an increase on the VAS for ``hallucinations. The incidence of
euphoria following lorcaserin administration in the human abuse
potential study is similar to that reported following zolpidem
(Schedule IV) administration (13-16%) and lower than that following
ketamine (Schedule III) administration (50%).
HHS stated that acutely, lorcaserin decreases locomotor activity in
rats. Tolerance does develop to this effect, because after 21 days,
lorcaserin does not affect the locomotor activity of the rats. DEA
further notes that a study showed that food intake in rats was reduced
after a single administration of lorcaserin. The doses administered
were 3, 6, 12, and 24 mg/kg. Lorcaserin decreased the cumulative food
intake at 2, 4, 6, and 22 hours.
HHS stated that acutely, lorcaserin decreases locomotor activity in
rats. Tolerance does develop to this effect, because after 21 days,
lorcaserin does not affect the locomotor activity of the rats. DEA
further notes that a study showed that food intake in rats was reduced
after a single administration of lorcaserin. The doses administered
were 3, 6, 12, and 24 mg/kg. Lorcaserin decreased the cumulative food
intake at 2, 4, 6, and 22 hours.
According to
HHS' review, there were two clinical studies conducted to determine the
ability of lorcaserin to induce physical dependence. The patients in
these studies were obese and lorcaserin was administered for 4 and 12
weeks prior to drug discontinuation. Upon lorcaserin discontinuation,
there were no signs of changes in mood, food interest, or body weight.
Discontinuation of lorcaserin administration to animals also did not
produce typical withdrawal symptoms. However, according to HHS, the
ability of lorcaserin to produce hallucinations, euphoria, and positive
subjective responses at supratherapeutic doses is suggestive of its
potential to produce psychic dependence.
Conclusion: Based on consideration of the scientific and medical
evaluation conducted by HHS and its recommendation, and after
considering its own eight-factor analysis, DEA has determined that
these facts and all relevant data constitute substantial evidence of
potential for abuse of lorcaserin. As such, DEA hereby proposes to
schedule lorcaserin as a controlled substance under the CSA.
Proposed Determination of Appropriate Schedule

The CSA establishes five schedules of controlled substances known
as Schedules I, II, III, IV, and V. The statute outlines the findings
required in placing a drug or other substance in any schedule. 21
U.S.C. 812(b). After consideration of the analysis and recommendation
of the Assistant Secretary for Health of HHS and review of all
available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b),
finds that:
(1) Lorcaserin has a low potential for abuse relative to the drugs
or other substances in Schedule III. The overall abuse potential of
lorcaserin is comparable to the Schedule IV substances;
(2) Lorcaserin has a currently accepted medical use in treatment in
the United States. Lorcaserin was approved for marketing by FDA as an
addition to a reduced-calorie diet and exercise, for chronic weight
management; and
(3) Abuse of lorcaserin may lead to limited psychological
dependence relative to the drugs or other substances in Schedule III.
This finding is based on the ability of lorcaserin to produce positive
subjective effects at supratherapeutic doses.
Based on these findings, the Administrator of DEA concludes that
lorcaserin, including its salts, isomers, and salts of isomers whenever
the existence of such salts, isomers, and salts of isomers is possible,
warrants control in Schedule IV of the CSA (21 U.S.C. 812(b)(4)).
Requirements for Handling Lorcaserin

If this rule is finalized as proposed, lorcaserin would be subject
to CSA regulatory controls and administrative, civil and criminal
sanctions applicable to the manufacture, distribution, dispensing,
importing and exporting of a Schedule IV controlled substance,
including the following:
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with lorcaserin, or who desires to manufacture, distribute,
dispense, import, export, engage in instructional activities or conduct
research with lorcaserin, would need to be registered to conduct such
activities pursuant to 21 U.S.C. 822 and in accordance with 21 CFR Part
1301.
Security. Lorcaserin would be subject to Schedules III-V security
requirements and would need to be manufactured, distributed, and stored
pursuant to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71,
1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c),
1301.76, and 1301.77.
Labeling and Packaging. All labels and labeling for commercial
containers of lorcaserin which are distributed on or after finalization
of this rule would need to be in accordance with 21 CFR 1302.03-
1302.07, pursuant to 21 U.S.C. 825.
Inventory. Every registrant required to keep records and who
possesses any quantity of lorcaserin would be required to keep an
inventory of all stocks of lorcaserin on hand pursuant to 21 U.S.C. 827
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Every
registrant who desires registration in Schedule IV for lorcaserin would
be required to conduct an inventory of all stocks of the substance on
hand at the time of registration.
Records. All registrants would be required to keep records pursuant
to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04,
1304.21, 1304.22, and 1304.23.
Prescriptions. All prescriptions for lorcaserin or prescriptions
for products containing lorcaserin would be required to be issued as a
controlled substance pursuant to 21 U.S.C. 829 and in accordance with
21 CFR 1306, including but not limited to 21 CFR 1306.03-1306.06,
1306.08, 1306.09, and 1306.21-1306.27.

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#24866

Re: Farmas USA

Lo que todavia le escuece a Wall Street es lo que se equivocaron con ARNA en Julio al apoyar sin reservas a VVUS. No dieron un dolar por ARNA. Y mira como les ha salido. Qsymia con un REMS del copón y sin vender en Europa.
ARNA es solo 45% institucional ( creo ), aunque ha aumentado esta cifra en los ultimos meses en mi opinion no es ni mucho menos suficiente acorde a una bio que ha conseguido que se le apruebe en USA la primera fat-pill en 13 años .
La masa retail, ese otro gran 55%, lleva ya tanto tiempo en este valor que los que estan en 11-13$ esperan vender en 20$ lo menos y asi lo han consolidado en sus cabezas durante todo este verano. Y los que han comprado en en los 8-9$ tienen en mente, como poco, esos 13$ del calenton de FDA-Julio. Y eso sin contar el tema Europa. Vamos, que son conscientes de que han comprado barato.

Es curioso como, ahora que esta a las puertas de iniciarse el lanzamiento, no dejo de leer avisos, warnings y aclaraciones sobre el futuro inmediato.
El futuro inmediato de ARNA es potencialmente la hostia en verso. Claro que hasta que vendan a pleno rendimiento les va a costar unos cuantos trimestres, unos cuantos. Y yo me pregunto, y que pasa? Que ahora ya no se descuenta nada por adelantado en Wall Street o que? Ya, ahora ya no, claro ...

Comite EMA, no dejo de leer lo de que están muy preocupados por el tema de los tumores en ratas. Se lea lo que se lea sobre la situacion con el comite europeo sale siempre dos palabras "tumor" y "ratas". Joder, pero que problema es ese? Un efecto secundario focalizado sobre la especie "roedor" no aplicable a la humana. Pues dale con tema, en todas partes. En mi opinon, old news.

No se que pasara, sinceramente. El comite tiene que demostrar independencia, hacer su trabajo y espero que así lo haga puesto que me siento mas tranquilo con el reglamento y filtros europeos que con los americanos.
Pero estoy seguro que si el comite da su recomendacion positiva de aprobacion, al dia siguiente sino el mismo dia sale un articulo seeking proclamando "no es vinculante, la recomendación no es vinculante, no obliga a EMA a nada".

El volumen de las ultimas sesiones es ESCANDALOSAMENTE RIDICULO. Ha marcado records incluso.
Nadie vende y los que quieren comprar no pueden.

La calma que precede a la tormenta, la calma que precede a la tormenta.

Yo en 11$ me apeo, a mi las tormentas me dan miedo. Truenos, relampagos ... Quita, quita ..

Edto: no habia leido tu ultimo post Anaramos.
"Coloca?" Joer, pues entonces es un blockbuster seguro! Ja,ja!

#24867

Re: Farmas USA

¿Alguien piensa asistir al aniversario de Rankia en Valencia?

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#24870

Re: Farmas USA

Buenos días. Me gustaría entrar a largo en alguna farmacéutica en USA. ¿Qué me recomendáis?

#24872

Re: Farmas USA

Alsayon, hola.
En vez de soltarte media docena de farmas a bocajarro te recomiendo que leas tranquilamente este hilo durante los proximos dias para que vayas formandote una opinion y cuando tengas seleccionadas por tu cuenta un par de farmas , pregunta ya algo concreto sobre ellas.

Es que si te digo ARNA y AMRN en los 8 bajos, pues igual te quedas como estabas,