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DARMSTADT, Germany and NEW YORK, USA, September 21, 2017 /PRNewswire/ — First approved immunotherapy for rare and aggressive skin cancer in the European Union, with initial launches planned in Germany and the UK Builds on Bavencio’s previous accelerated approvals in the US and recent approval in Switzerland Approval based on data from Javelin Merkel 200 study including durable tumor response rate and duration of response Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: […]

VANCOUVER, British Columbia, and MENLO PARK, Calif., Sept. 18, 2017 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) (“DelMar” and “the Company”), a biopharmaceutical company focused on the development of new cancer therapies, today announced that the U.S. Food and Drug Administration (“FDA”) has allowed an additional Investigational New Drug Application (“IND”) to study its lead […]

Pfizer just got some badly needed good news for its newly acquired cancer drug Xtandi. After watching sales sink right after it acquired the therapy and all of Medivation for $14 billion, researchers say the drug cleared the Phase III study for non-metastatic, castration resistant prostate cancer. And at least one prominent analyst says that’s […]

SILVER SPRING, Md., Sept. 14, 2017 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration today granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often comes back even after […]

Roche’s immuno-oncology drug Tecentriq took a surprising punch earlier this year when it failed a bladder cancer trial, putting a conditional approval in jeopardy. But the threat of losing FDA approval in bladder cancer has now passed. After recent discussions with the agency, the company expects Tecentriq’s accelerated approval “will be maintained,” a spokeswoman with […]

BOSTON, Sept. 11, 2017 /PRNewswire/ — BERG, a biopharmaceutical company that merges biology with technology to map the nature of diseases, today announced two poster presentations showing promising clinical data that were unveiled at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, from September 8-12: Results from a Phase II study of […]

TARRYTOWN, N.Y. and PARIS, Sept. 8, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, […]

Data presented at ESMO has demonstrated that a new blood test from Roche, co-developed with Foundation Medicine, can accurately measure the number of mutations within a tumour, which may help doctors to know which patients respond best to certain immunotherapies. Tumour mutational burden (TMB) is a quantitative clinical marker that measures the number of mutations […]

The outlook brightened today for Bristol-Myers Squibb’s Opdivo as combo med as the drugmaker released more results from a test of its Opdivo-plus-Yervoy combination as a first-line treatment in kidney cancer. The overall survival results were promising enough that BMS stopped the trial early. Today’s report led one analyst to predict “a very high likelihood […]

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