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#93857

Re: Farmas USA

Con la de hoy, nos quedan 13 sesiones en Septiembre... a ver si nos sueltan las news más pronto que tarde.

NVAX

#93858

Re: Farmas USA

A ver si es verdad... esta espera... jejeje

#93859

Re: Farmas USA

A mi se me está haciendo eterna...

#93860

Re: Farmas USA

NVAX
Obviamente es especulación pura pero supongo que si se ciñen a la promesa de final de Q3, lo harán en la semana del 26 al 30 de septiembre. Dada la fecha del investor anual meeting, supongo que la fecha de liberación de datos querrán que sea lo más próxima al 11 Octubre.
Se sabe quien es el líder de opinión en RSV que llevan para el investor day?

#93861

Re: Farmas USA

esta es la mejor:
https://novavax.applicantpro.com/jobs/431445.html
Senior Director, Marketing, RSV Vaccines
Habrán contratado ya a alguien para el puesto?
NVAX

#93863

Re: Farmas USA

ARRY
Array Biopharma Announces Phase 3 Beacon Crc Spa Agreement With Fda

The following excerpt is from the company's SEC filing.

BOULDER, Colo., Sept. 14, 2016 /PRNewswire/ -- Array BioPharma (Nasdaq: ARRY) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with

-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.

"Colorectal cancer is the third most common cancer among men and women in the United States and

mutant CRC represents a high unmet medical need, as there are currently no targeted treatment options available for patients with this form of the disease," said Scott Kopetz, M.D., Ph.D., of the University of Texas MD Anderson Cancer Center in Houston and BEACON CRC investigator. "The SPA agreement between Array and the FDA represents a welcome next step for the CRC community and, as a physician, I look forward to exploring these novel treatment combinations."

The SPA provides agreement that the design and planned analysis of BEACON CRC adequately address the objectives necessary to support a regulatory submission for the approval of the doublet regimen of encorafenib and Erbitux

. The FDA also communicated that sharing evidence from the study that the triplet regimen (encorafenib, Erbitux and binimetinib) both met its primary endpoint (Overall Survival) as compared to the control arm, and demonstrated a clinically meaningful benefit as compared to the doublet regimen, would provide support for approval of the triplet regimen.

Trial Design

BEACON CRC is a randomized, open-label, global study evaluating the efficacy and safety of encorafenib and Erbitux, with or without binimetinib, in patients with

-mutant metastatic CRC who have previously received first-or second-line systemic therapy. The study includes a safety lead-in with approximately 30 patients. With appropriate results from the lead-in, approximately 615 patients are expected to be randomized 1:1:1 to receive triplet therapy (encorafenib, Erbitux and binimetinib), doublet therapy (encorafenib and Erbitux) or the control arm (irinotecan-based therapy and Erbitux). The primary endpoint of the trial is OS of the triplet therapy compared to the control arm. Secondary endpoints address efficacy of the doublet therapy compared to the control arm, and the triplet therapy compared to the doublet therapy. Other secondary endpoints include progression-free survival (PFS), objective response rate (ORR), duration of response, safety and tolerability. Health related quality of life data will also be assessed.

Array is conducting BEACON CRC in partnership with Pierre Fabre and Merck KGaA, Darmstadt, Germany at over 250 investigational sites in North America, South America, Europe and the Asia Pacific region. Patient enrollment is expected to be completed in 2018.

About

-mutant Metastatic Colorectal Cancer

Colorectal cancer is the third most common cancer among men and women in the United States, with more than 134,000 new cases and nearly 50,000 deaths from the disease projected in 2016. In the United States,

mutations occur in 8 to 15 percent of patients with colorectal cancer and represent a poor prognosis for these patients. Historical published PFS and OS results after first-line treatment range from 1.8 to 2.5 months and 4 to 6 months, respectively, and published response rates from various studies for EGFR-based therapy in this population range from 6 percent to 8 percent.

About Binimetinib & Encorafenib

MEK and BRAF are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in this pathway.

Binimetinib and encorafenib are being studied in Phase 3 trials in advanced cancer patients, including the COLUMBUS trial studying encorafenib and binimetinib in combination in patients with

-mutant melanoma and the recently initiated BEACON CRC trial that will study encorafenib in combination with Erbitux, with or without binimetinib, in patients with

BRAF V600E

-mutant colorectal cancer. On September 1, 2016, Array announced that the FDA has accepted its New Drug Application (NDA) for binimetinib with a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2017. Array completed its NDA submission of binimetinib in late June 2016 based on findings from the pivotal Phase 3 NEMO trial in patients with NRAS-mutant melanoma.

About a Special Protocol Assessment

A Special Protocol Assessment (SPA) is a process by which sponsors ask the FDA to evaluate a protocol to determine whether it adequately addresses scientific and regulatory requirements for the purpose identified by the sponsor. A SPA agreement indicates concurrence with the adequacy and acceptability of specific critical elements of protocol design and analysis. To review the FDA's complete SPA guidance, please click the following link:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM498793.pdf