Medical Tidbits, FDA Approves IMLYGIC™ (Talimogene Laherparepvec) As First Oncolytic Viral Therapy In The US

breaking medical news

IMLYGIC Indicated for the Local Treatment of Unresectable Cutaneous, Subcutaneous and Nodal Lesions in Patients With Melanoma Recurrent After Initial Surgery
Patients Treated With IMLYGIC Achieved a Significant Increase in Durable Response Rate in Pivotal Study

THOUSAND OAKS, Calif., Oct. 27, 2015 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for IMLYGIC™ (talimogene laherparepvec), a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery. IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study.1-3   read more

Mylan Launches Generic Fusilev® for Injection

Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Levoleucovorin Calcium Injection 10 mg (base)/mL; 175 mg (base)/17.5 mL and 250 mg (base)/25 mL Single-use Vials, which is the generic version of Spectrum Pharmaceuticals’ Fusilev® for Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for rescue use after high-dose methotrexate therapy in osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid more

Amgen and Cytokinetics Announce Positive Top-Line Results From COSMIC-HF, A Phase 2 Trial of Omecamtiv Mecarbil in Patients With Chronic Heart Failure

Data Showed Statistically Significant Improvements in Several Pre-Specified Measures of Cardiac Function

THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., Oct. 27, 2015 /PRNewswire/ –Amgen (NASDAQ:AMGN) and Cytokinetics Incorporated (NASDAQ:CYTK) today announced that data from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, showed statistically significant improvements in several measures of cardiac function, including systolic ejection time, stroke volume and N-terminal-pro-brain natriuretic peptide, at 20 weeks following randomization. read more

Walgreens Boots Alliance to Acquire Rite Aid for $17.2 Billion in All-Cash Transaction

DEERFIELD, Ill. & CAMP HILL, Pa.–(BUSINESS WIRE)–Walgreens Boots Alliance, Inc. (Nasdaq: WBA) and Rite Aid Corporation (NYSE: RAD) today announced that they have entered into a definitive agreement under which Walgreens Boots Alliance will acquire all outstanding shares of Rite Aid, a U.S. retail pharmacy chain, for $9.00 per share in cash, for a total enterprise value of approximately $17.2 billion, including acquired net debt. The purchase price represents a premium of 48 percent to the closing price per share on 26 October 2015, the day before the agreement was signed. The combination of Walgreens Boots Alliance and Rite Aid creates a further opportunity to deliver a high-quality retail pharmacy choice for U.S. consumers in an evolving and increasingly personalized healthcare environment.  read more

Telesta Therapeutics and Ipsen Announce Exclusive License Agreement for MCNA1 for the Treatment of Non-Muscle Invasive Bladder Cancer in Major Ex-United States Territories

Ipsen (Euronext: IPN – ADR: IPSEY) and Telesta Therapeutics Inc. (TSX:TST; PNK:BNHLF) today announced that they have entered into an exclusive licensing agreement for Ipsen to develop and commercialize MCNA1 for the treatment of high risk non-muscle invasive bladder cancer (NMIBC) in all countries of the world, with the exception of the United States, where Telesta is establishing commercial operations, Canada, South Africa, Mexico, South Korea and Japan.

Merck’s Pembrolizumab Shows Superior Overall Survival Compared to Chemotherapy in Patients with Previously Treated Advanced Non-Small Cell Lung Cancer Whose Tumors Express PD-L1  

KIRKLAND, QC, Oct. 28, 2015 /CNW Telbec/ – Merck (NYSE: MRK), known as MSD outside Canada and the United States, today announced topline results from the KEYNOTE-010 study of pembrolizumab in advanced non-small-cell lung cancer (NSCLC) demonstrating that the trial met its primary objective.

KEYNOTE-010 is a randomized, pivotal Phase 2/3 trial comparing two doses of pembrolizumab (2mg/kg dose and a higher 10mg/kg dose, each given every 3 weeks), to docetaxel, a commonly used chemotherapy. Patients were enrolled who had failed prior systemic therapy for advanced NSCLC and whose tumors had PD-L1 (programmed death ligand-1) expression tumor proportion scores (TPS) of 1 percent or more. Outcomes were assessed in patients whose tumors were strongly PD-L1 positive (defined as TPS of 50 percent or more), and in all PD-L1 positive patients. read more

Trovagene’s Urine-Based Liquid Biopsy Platform Shows Clinical Sensitivity of 93 Percent in Lung Cancer Study

SAN DIEGO, Oct. 27, 2015 /PRNewswire/ — Trovagene, Inc., (NASDAQ:  TROV) a developer of cell-free molecular diagnostics, today announced the presentation of clinical data featuring the use of its Precision Cancer Monitoring℠ (PCM) platform for the quantitative detection and monitoring of EGFR T790M mutations in patients diagnosed with non-small cell lung cancer. Dr. Shirish Gadgeel, Karmanos Cancer Institute in Detroit, a NCI-designated comprehensive cancer center, is the lead author on data that will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on November 6, 2015 in Boston, MA. The data are an exploratory analysis of 63 patients from a Phase I/II study of rociletinib, a 3rd generation EGFR inhibitor being developed by Clovis Oncology for the treatment of EGFR-mutant non-small cell lung cancer (NCT01526928). read more


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