Metastatic melanoma – pharmaceutical daily

November 27, 2015 Off

FDA needs more data in BRAF mutated patients for Bristol-Myers’ Opdivo for BRAF V600 metastatic melanoma

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for Bristol-Myers Squibb Company’s supplemental Biologics License…

November 11, 2015 Off

Diplomat to dispense melanoma drug “Cotellic” in combination with “Zelboraf”

By Dino Mustafić

Diplomat Pharmacy, NYSE-listed pharmaceutical company, will dispense Cotellic in combination with the BRAF inhibitor Zelboraf to treat patients with advanced melanoma that cannot be removed by surgery, or that has spread from the primary site.

October 8, 2015 Off

Merck and Pfizer Announce Investigational Immunotherapy Avelumab Receives FDA Fast Track Designation for Metastatic Merkel Cell Carcinoma

By Dino Mustafić

Merck KGaA and Pfizer have announced that the US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.

October 2, 2015 Off

Merck and DNAtrix to evaluate the efficacy and safety of DNX-2401

By Dino Mustafić

Merck, known as MSD outside the United States and Canada, and DNAtrix announced on Thursday that they have entered into an oncology clinical study collaboration to evaluate the efficacy and safety of DNX-2401, DNAtrix’s oncolytic immunotherapy, in combination with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase 2, multi-centered study of patients with recurrent glioblastoma, the most aggressive form of brain cancer for which there is no cure.

September 13, 2015 Off

European Commission approves Tafinlar and Mekinist combination

By Dino Mustafić

The European Commission has approved the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with…