FDA Da Luz Verde a la Primera Versión Genérica del Antitumoral ' Doxil ' ( Johnson & Johnson ) .

La Agencia Americana del Medicamento (FDA, en sus siglas en inglés) ha autorizado la comercialización de la primera versión genérica del tratamiento contra el cáncer clorhidrato de doxorrubicina liposomal, cuyo nombre comercial es 'Doxil' (Johnson&Johnson), a cargo de la farmacéutica india Sun Pharma Global.


Este fármaco, que estará disponible en viales de 20 y 50 miligramos, fue aprobado por vez primera en 1995 y actualmente está indicado para tratar el cáncer de ovario, el sarcoma de Kaposi relacionado con el sida y el mieloma múltiple.

El fármaco se vio afectado en 2011 por unos problemas de fabricación que acabaron provocando la suspensión de su producción ante el riesgo de que este incidente afectara al control de calidad.

Esto hizo que en febrero pasado la FDA permitiera la importación temporal de 'LipoDox', desarrollada por Sun y que contiene el mismo principio activo que 'Doxil'. La agencia dijo que tiene la intención de continuar permitiendo la importación de 'LipoDox' hasta que Sun haya producido suficientes fármacos genéricos para satisfacer la demanda.

El presidente de Estados Unidos, Barack Obama, reconoció en 2011 que la escasez de medicamentos se había convertido en una prioridad para su Gobierno.

FDA Approves Generic Doxil to Combat Drug Shortage .

It can pay to play with the FDA when it needs help with drug shortages. In a push to ease a months-long shortage of Johnson & Johnson's ($JNJ) cancer drug Doxil, the FDA fast-tracked a generic from Sun Pharma, approving it Monday.

Since February, the FDA had been allowing Sun to import its unapproved version of the Doxil substitute as one way for the agency to address the shortage.

Doxorubicin hydrochloride liposome injection sits on the FDA's drug shortage list, meaning the regulatory agency's Office of Generic Drugs can use a priority review system to bump a generic application for the drug to the front of the line.
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GRIFOLS ADR : PROLASTIN® Celebrates 25 Years as Leading Augmentation Therapy for Treatment of Alpha ( 1 ) - Antitrypsin Deficiency .

RESEARCH TRIANGLE PARK, N.C., Feb. 5, 2013 /PRNewswire/ -- Grifols, a global healthcare company based in Barcelona, Spain, is commemorating the 25(th) anniversary year of PROLASTIN(®) (alpha(1)-proteinase inhibitor [human]) and the 50th anniversary of the discovery of alpha(1)-antitrypsin deficiency (Alpha1) with a series of events and programs around the world aimed at raising awareness and advancing research into the treatment of alpha1. This rare and life-threatening disease causes genetic emphysema due to low circulating levels of the alpha(1)-antitrypsin protein.

PROLASTIN was launched in the U.S. in February 1988 as the first and only FDA-approved therapy for the treatment of alpha1 by augmenting patients' levels of the alpha(1)-antitrypsin protein. Twenty-five years later, the PROLASTIN brand of products remains the global market leader for the treatment of this debilitating lung disease, first identified by Swedish researchers Carl-Bertil Laurell and Sten Eriksson in 1963.

"For nearly 17 years, PROLASTIN was the only product available to patients with Alpha-1," said Dr. Sandy Sandhaus, Professor of Medicine and Director, Alpha(1)-Antitrypsin Deficiency Program at National Jewish Health in Denver, CO. "Since the beginning, the makers of PROLASTIN have been remarkable partners with the patient community in helping to improve their health, educate patients about a little-known disease, and support scientific research to find better ways to detect and treat the disease."

"The level of patient support from the manufacturer of PROLASTIN helped many people change their lives," Sandhaus added.

To commemorate the 25(th) anniversary of PROLASTIN and the 50(th) anniversary of the discovery of the disease, Grifols is sponsoring a series of events, including the Alpha-1 Foundation's International Patient Congress in Barcelona and a National Education Conference in Washington, D.C. These events will promote dialogue and collaboration among patients, scientists, and healthcare providers. The goal is to increase diagnosis and promote research into a rare disease that remains vastly under-diagnosed, with an estimated five percent of affected individuals having been properly identified.

On the research front, Grifols continues to pursue initiatives with the goal of enhancing the understanding of alpha1 and devising better treatment options for patients. Toward that end, Grifols will initiate a multicenter clinical trial this summer to study the efficacy of multiple doses of PROLASTIN(®)-C - a more purified and concentrated formulation of PROLASTIN approved in the U.S. in 2009 and in Canada in 2010.

The development of PROLASTIN-C is one example of Grifols' ongoing commitment to devising novel therapeutic products and services. Additional initiatives include the distribution of free Alpha-1 diagnostic kits and the comprehensive disease-management program, PROLASTIN Direct(®).

Alzheimer Avanza de forma inversa al Aprendizaje Infantil .

Un estudio del Instituto Hospital del Mar de Investigaciones Médicas (IMIM) ha demostrado que la enfermedad del Alzheimer progresa en las personas de forma inversa al aprendizaje de los niños.


El estudio, publicado en la revista 'Journal of Alzheimer's Disease', ha certificado que la pérdida de capacidades de los enfermos de Alzheimer procede de forma inversa al patrón que siguen los niños para adquirir nuevas facultades, lo que, según el IMIM, mejora el conocimiento de las pautas evolutivas de la enfermedad.

La investigación ha consistido en comparar 181 niños con edades comprendidas entre 4 y 12 años y 148 adultos con diferentes niveles de demencia: cognitivamente normales, con un deterioro cognitivo leve y con un estadio moderado y severo de Alzheimer.

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