18 marzo 2020
China Desarrolla una #vacuna contra el #coronavirus . Una Vacuna Inmunizaria a la población de riesgo o sea la Vacuna sería Preventiva ( Lo que vemos cada año cuando vacunan a los Mayores de 60 Años) .Lo que Realmente hace Falta de Manera Urgente ... ES UN TRATAMIENTO !!!.
17 marzo 2020
Lurbinectedin . Según Jason Niu , Oncólogo Torácico y Director del Programa de Cáncer de Pulmón en el Centro de Cáncer Banner MD Anderson , Espero que este Agente Sea Aprobado Pronto.
JESSICA HERGERT
Monday, March 16, 2020
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| Jiaxin ( Jason ) MD, PhD |
In the second-line setting, what developments have been made with Lurbinectedin?
Lurbinectedin is a very interesting compound. The first-generation agent trabectedin (Yondelis) is approved to treat patients with sarcoma, but lurbinectedin is more of a second-generation synthetic drug. As a result, lurbinectedin is a more potent and better-tolerated agent than trabectedin.
A phase I/Ib study looked at lurbinectedin alone and in combination with doxorubicin, and results showed a synergistic effect between the combined agents. As a result, a phase II basket trial enrolling patients with ovarian cancer, breast cancer, and SCLC was conducted. The results of the SCLC cohort were presented at the 2019 ASCO Annual Meeting.
The trial enrolled about 105 patients with platinum-sensitive and platinum-resistant SCLC. Both groups showed impressive responses. In particular, single-agent lurbinectedin demonstrated up to a 45% response rate and an 11-month median OS for patients with platinum-sensitive SCLC.
This agent is well tolerated. We mainly see hematologic toxicities, which are manageable from a medical oncology standpoint. As such, I fully expect this agent to be approved soon.
...
Jazz Phamaceuticals en el Radar de los Accionistas que buscan empresas de Biotecnología a Precios de Ganga . Lurbinectedin could help the company decrease its top-line exposure to Xyrem.
Jazz's Pipeline Is Promising.
Jazz boasts several exciting products in its pipeline or that are currently being evaluated by health regulators.
First, the company submitted a New Drug Application (NDA) for JZP-258 to the U.S. Food and Drug Administration (FDA) in January. JZP-258 is a potential treatment for cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.
Narcolepsy, a chronic sleep disorder that affects about one in 2,000 people in the U.S., is severely under-diagnosed: Up to 50% of those with this condition have not been diagnosed. Furthermore, narcolepsy is associated with other conditions, such as hypertension and cardiovascular disease. For those reasons, Jazz has high hopes for JZP-258.
Second, Jazz submitted an NDA to the FDA for Lurbinectedin for the treatment of relapsed small-cell lung cancer (SCLC). Lurbinectedin was granted a priority review by the FDA, which means the review process will be shorter than usual.
There are about 30,000 cases of SCLC in the U.S. per year. The company said: "There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved." Jazz is expecting an answer from the FDA in mid-August, and if approved, Lurbinectedin could help the company decrease its top-line exposure to Xyrem.
First, the company submitted a New Drug Application (NDA) for JZP-258 to the U.S. Food and Drug Administration (FDA) in January. JZP-258 is a potential treatment for cataplexy and excessive daytime sleepiness (EDS) associated with narcolepsy.
Narcolepsy, a chronic sleep disorder that affects about one in 2,000 people in the U.S., is severely under-diagnosed: Up to 50% of those with this condition have not been diagnosed. Furthermore, narcolepsy is associated with other conditions, such as hypertension and cardiovascular disease. For those reasons, Jazz has high hopes for JZP-258.
There are about 30,000 cases of SCLC in the U.S. per year. The company said: "There remains a critical unmet need for patients with relapsed SCLC, as the treatment landscape has not changed substantially in more than two decades since the last new chemical entity, topotecan, was approved." Jazz is expecting an answer from the FDA in mid-August, and if approved, Lurbinectedin could help the company decrease its top-line exposure to Xyrem.
APLIDIN IL FARMACO DELLA SPERANZA.
Allora non se ne esce dal labirinto ecco perchè è fondamentale trovare nel vitro l’anticorpo universale che riesca a schiacciare il Covid-19.
In base ad una ricerca approfondita che arriva dalla Spagna e che dà buone speranze, il colosso farmaceutico PharmaMar avrebbe individuato nel APLIDIN, quel farmaco in grado di salvare molte vite umane. E’ composto a base di plitidepsina, spiegano i ricercatori, è ha superato positivamente il test in vitro per il coronavirus umano HCoV-229E, un patogeno con un meccanismo di moltiplicazione e propagazione molto simile a quello del Covid-19.
I suoi effetti – Quando il farmaco entra nel corpo si lega automaticamente a una proteina umana, essenziale per la malattia Sars-CoV-2 per diffondersi nel corpo. Aplidin potrebbe inibire la capacità di diffusione del virus e quindi la sua riproduzione.
Chiudo con la speranza che questa ricerca fondata, possa tornare a dare ossigeno ai polmoni del Mondo, perchè non esiste un angolo immune e la guerra la si vince, con le strategie che solo la medicina e la scienza sono in grado di scoprire.
In questo momento i cannoni possono rimanere senza le bombe.
In questo momento i cannoni possono rimanere senza le bombe.
16 marzo 2020
Aplidin® es 1000 Veces Más Potente que los AntiViricos que se están Probando . Aplidin® , a Diferencia del Resto , No Ataca a las Proteínas del Virus , por lo que Evita que el Virus Mute y Genere Resistencias .
Aplidin® CNB//CSIC .
Sonia Zúñiga ( CNB_CSIC ) :
Aplidin ha Funcionado "Muy Bien, Porque Ha Impedido la Multiplicación del Virus Incluso en Concentraciones Pequeñas, que sabemos que Son Seguras porque son más Pequeñas que las que se Utilizan en Clínica para Tratar el Myeloma" . ...
15 marzo 2020
Coronavirus ( COVID19 ) . Diferencia entre Vacuna y Tratamiento .
**.- Tratamiento sirve para la cura o el alivio de la enfermedad o síntomas.
Estudio y Aprobación Prioritaria de #Aplidin de #Pharmamar para Tratamiento de #Coronavirus . Firma está Petición y difunde ... ¡ Por Favor ... El 60 % de la población contraeremos el #COVID19 ! . Gracias .
Cabe destacar que Aplidin ya ha realizado todos los ensayos clínicos y que ha obtenido la aprobación en Australia para el tratamiento de Cáncer de Myeloma .
... En Europa no fue Aprobado por ...
¡¡¡ Sin comentarios !!!
*********
COVID-19: developers of medicines or vaccines to benefit from free scientific advice .
Developers of potential therapeutics or vaccines against COVID-19 are invited to contact the Agency as soon as possible with information about their proposed development, by emailing
2019-ncov@ema.europa.eu. In a first round of discussions, EMA can provide preliminary informal comments and feedback on the development. This will then allow the Agency to identify the products which are mature enough to benefit from fast-track scientific advice, to guarantee best use of this tool.
In the context of the COVID-19 pandemic, with this fast-track scientific advice, the Agency can give developers prompt guidance and direction on the best methods and study designs to generate robust information on how well a medicine or vaccine works and how safe it is.
Since the beginning of the outbreak, the Agency has organised teleconferences with several developers of potential medicines and vaccines against COVID-19. Member States are kept updated on these activities. EMA is also working closely with international regulatory authorities.
EMA is actively supporting the World Health Organization’s (WHO) activities on the prioritisation and analysis of available evidence. Most potential therapeutics initially identified in this context are repurposed agents (i.e. medicinal products already authorised for another purpose) or investigational agents that are or will be investigated for treatment and in some cases for prophylaxis against the disease. EMA’s priority is to accelerate the approval of safe and effective therapeutic candidates to treat people infected by the virus as soon as possible.
...
14 marzo 2020
13 marzo 2020
#Nasdaq .Com . #Covid_19. #EEUU #PharmaMar Says Test of Potential #coronavirus #Drug Promising .
PUBLISHED // Mar 3, 2020 4:27AM EDT .
Pharma Mar Says Test of Potential Coronavirus Drug Promising | NASDAQ
MADRID, March 13 (Reuters) - Spanish pharmaceutical company Pharma Mar PHMR.MC said on Friday tests carried out in test tubes with its cancer drug Aplidin on samples of a virus similar to the COVID-19 coronavirus were encouraging.
Investigators from Spain's biotech centre Centro Nacional de Biotecnologia del Centro Superior de Investigaciones Cientificas showed Aplidin has a positive effect on multiplication and propagation of the virus, Pharma Mar said in a statement on Friday.
The company will contact regulatory authorities to analyse the possibility of testing the drug on patients with the COVID-19 coronavirus.
Aplidin is marketed in countries like Australia as a treatment for certain blood cancers.
MADRID, March 13 (Reuters) - Spanish pharmaceutical company Pharma Mar PHMR.MC said on Friday tests carried out in test tubes with its cancer drug Aplidin on samples of a virus similar to the COVID-19 coronavirus were encouraging.
Investigators from Spain's biotech centre Centro Nacional de Biotecnologia del Centro Superior de Investigaciones Cientificas showed Aplidin has a positive effect on multiplication and propagation of the virus, Pharma Mar said in a statement on Friday.
The company will contact regulatory authorities to analyse the possibility of testing the drug on patients with the COVID-19 coronavirus.
Aplidin is marketed in countries like Australia as a treatment for certain blood cancers.
EEUU Suspende la Prueba de las Pruebas . Una Cadena de Retrasos y Fallos Sumada a Regulaciones y Burocracia han Limitado los Test de Coronavirus en el País .
CNMV prohíbe las apuestas bajistas para frenar el pánico en la Bolsa española .
La medida se aplica el viernes para 69 empresas que cayeron más del 10% el jueves, todas las del Ibex menos Grifols, Viscofan y MásMóvil .
Las empresas blindadas contra los hedge funds bajistas –solo el viernes, al menos de momento– son: Abengoa B, Acciona, FCC, Iberdrola, Acerinox, ACS, Aedas, Aena, Airbus, Amadeus, Aperam, Applus, ArcelorMittal, Atresmedia, Audax, BBVA, Sabadell, Santander, Bankia, Bankinter, Biosearch, CaixaBank, Cellnex, CIE, Coca-Cola European Partners, Codere, Logista, CAF, Enagás, Ence, Endesa, Ercros, Euskaltel, Faes, Ferrovial, Fluidra, Gestamp, Dominion, Grenergy, Catalana Occidente, San José, Indra, Inditex, Colonial, IAG, Lar. Liberbank, Mapfre, Mediaset España, Meliá, Merlin, Metrovacesa, Naturgy, Naturhouse, NH Hotel Group, Oryzon Genomics, PharmaMar, Prosegur, Red Eléctrica, Renta Corporación, Repsol, Sacyr, Siemens Gamesa, Solaria, Talgo, Técnicas Reunidas, Telefónica y Unicaja Banco. Del Ibex, solo Grifols, MásMóvil y Viscofan quedan fuera del escudo antibajistas.
Las empresas blindadas contra los hedge funds bajistas –solo el viernes, al menos de momento– son: Abengoa B, Acciona, FCC, Iberdrola, Acerinox, ACS, Aedas, Aena, Airbus, Amadeus, Aperam, Applus, ArcelorMittal, Atresmedia, Audax, BBVA, Sabadell, Santander, Bankia, Bankinter, Biosearch, CaixaBank, Cellnex, CIE, Coca-Cola European Partners, Codere, Logista, CAF, Enagás, Ence, Endesa, Ercros, Euskaltel, Faes, Ferrovial, Fluidra, Gestamp, Dominion, Grenergy, Catalana Occidente, San José, Indra, Inditex, Colonial, IAG, Lar. Liberbank, Mapfre, Mediaset España, Meliá, Merlin, Metrovacesa, Naturgy, Naturhouse, NH Hotel Group, Oryzon Genomics, PharmaMar, Prosegur, Red Eléctrica, Renta Corporación, Repsol, Sacyr, Siemens Gamesa, Solaria, Talgo, Técnicas Reunidas, Telefónica y Unicaja Banco. Del Ibex, solo Grifols, MásMóvil y Viscofan quedan fuera del escudo antibajistas.
«Science» carga contra Trump por el Coronavirus Acusa al presidente de intentar silenciar información y le advierte de que ahora sus palabras son ‘cuestión de vida y muerte’ Le recuerda que, por mucho que insista, la vacuna contra la Covid-19 puede tardar por lo menos un año y medio .
«Háganos un favor, señor presidente. Si quiere algo, comience a tratar a la ciencia y sus principios con respeto». En un ácido editorial publicado esta semana en la revista « Science », su editor jefe, H. Holden Thorp, ha cargado contra las recientes exigencias de Donald Trump a la industria farmacéutica, a la que pidió «acelerar» sus trabajos en la búsqueda de una vacuna contra el coronavirus. ...
12 marzo 2020
OPDIVO AND YERVOY COMBINATION WINS ACCELERATED APPROVAL FOR HCC .
... La Administración de Drogas y Alimentos de los Estados Unidos (FDA) dio luz verde acelerada a la combinación de Opdivo y Yervoy de Bristol-Myers Squibb como tratamiento para el carcinoma hepatocelular en pacientes que han sido tratados previamente con Bayer Nexavar (sorafenib).
La aprobación para el tratamiento combinado se basó en los resultados del ensayo de fase I / II CheckMate-040 en el que Opdivo y Yervoy mostraron una tasa de respuesta global del 33% en esta población de pacientes. De ellos, el 8% tuvo una respuesta completa y el 24% mostró una respuesta parcial. La duración de las respuestas (DOR) varió de 4.6 a 30.5 meses, con un 88% de duración de al menos seis meses, un 56% de al menos 12 meses y un 31% de al menos 24 meses, dijo BMS. ...
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