Farmas USA

Estuve apunto de hace una entrada en los últimos minutos del after-hours del viernes pasado a 91,25$ cuando se anunció el rumor de que Merck haría una oferta de 100-102$ por Cubist Pharmaceuticals, Inc. (CBST).

Y me encuentro esta mañana que CBST se ha marchado hasta los 99,98$.

Ainchhh... en fin, otra vez será.

Una pena, yo cuando empezé a desgranar farmas estuve a punto de comprar Trius por el Tedizolid un antibiótico cojonudo, al final trius la compro Cubist y parece que a Cubist también se la van a merendar.

Creo que hoy puede ser el dia de todas las que han presentado datos cojonudos en el Americano de hematología, Agios, Pharmacyclics, TGTX...

Gale ha presentado datos y aunque sube en premarket tan solo es una nueva formulación de algo que ya esta aprobado y cualquiera que la llevara debería saber que iba a ir bien, vamos que no es ninguna novedad bestial como en las anteriores, no le doy importancia.

futuros en rojo :(

Advaxis (ADXS) Receives FDA Clearance for ADXS-PSA Combo IND Application (MRK)

December 8, 2014 7:46 AM EST Send to a Friend
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Advaxis (Nasdaq: ADXS) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to conduct a Phase 1/2 clinical study to evaluate the combination of ADXS-PSA (ADXS31-142) with KEYTRUDA (pembrolizumab), marketed by Merck & Co., Inc. (NYSE: MRK), in patients with previously treated, metastatic castration-resistant prostate cancer (mCRPC). The clinical trial, which will be the first-in-human study of Advaxis's lead Lm-LLO immunotherapy product candidate in prostate cancer, is expected to begin patient enrollment in the first quarter of 2015.

The open-label Phase 1/2 clinical trial is designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with KEYTRUDA, the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States. KEYTRUDA is developed and marketed by Merck.

The Phase 1 part of the study will be a dose-escalating study designed to establish the maximum tolerated dose of ADXS-PSA when used alone and in combination with KEYTRUDA. The Phase 2 portion will assess the safety and efficacy of the combination immunotherapy regimen. Advaxis and Merck will collaboratively oversee the conduct of the study and will use the results from the trial to determine the future clinical development program for the combination.

"Combinations of immunotherapies are the future of cancer research," stated Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "We are extremely pleased with FDA's acceptance of this IND because it gives us the opportunity to conduct clinical trials of ADXS-PSA in combination with an important, FDA approved PD-1 inhibitor, KEYTRUDA."

O'Connor continued, "This open-label study will provide Advaxis clinical data by which we can evaluate the potential of our proprietary Lm-LLO immunotherapy technology to enhance the activity of an anti-PD-1 antibody. During preclinical studies, our immunotherapies demonstrated a synergistic anti-tumor immune response when combined with a PD-1 inhibitor. We look forward to the possibility of seeing these encouraging results again, this time in a clinical setting, with the hopes of offering a promising alternative treatment option for patients diagnosed with an aggressive and difficult to treat form of prostate cancer."

ADXS-PSA and KEYTRUDA are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body's own defenses in fighting cancer. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response.

ADXS

Cellceutix Antibiotic Brilacidin Receives QIDP Designation From FDA

BEVERLY, MA--(Marketwired - Dec 8, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, and antimicrobial applications, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation for Brilacidin as a new treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) ahead of its meeting this month with Cellceutix regarding Cellceutix's planned Phase 3 trial of Brilacidin for ABSSSI. Brilacidin, the Company's lead drug in a new class of antibiotics called defensin-mimetics, completed a Phase 2b trial in September showing, amongst other things, a single dose of Brilacidin to be as effective in treatment of ABSSSI as a FDA-approved seven-day dosing regimen of daptomycin.

The QIDP designation was established as part of the Generating Antibiotic Incentives Now (GAIN) Act, passed by the U.S. Congress in July 2012, for the purpose of encouraging pharmaceutical companies to develop new antimicrobial drugs to treat serious and life-threatening infections. Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.

CTIX

A ver si se animan ambos valores este lunes de regreso vacaional

ADXS/CTIX

juas IBB 313