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Monthly Archives: March 2017

AstraZeneca’s Lynparza Granted FDA Priority Review for Maintenance Setting in Ovarian Cancer Patients

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for LYNPARZA™ (olaparib) tablets (300mg twice daily) for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. The FDA has also granted priority review status with a …

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Bristol-Myers Collaborates with Parker Institute and CRI for Immuno-Oncology Research

NEW YORK & SAN FRANCISCO–(BUSINESS WIRE)–The Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb Company (NYSE: BMY) and the Cancer Research Institute (CRI) today announced a multi-year clinical research collaboration to coordinate and rapidly initiate clinical Immuno-Oncology (I-O) studies across the Parker Institute and CRI networks. Bristol-Myers Squibb will work closely …

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Protein Identified as Potential Druggable Target for Pancreatic Cancer

A protein known as arginine methyltransferase 1 (PRMT1) may be a potential therapeutic target for pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer, and one of the most deadliest with a less than 10 percent, five-year survival rate. PRMT1 is involved in a number of genetic processes …

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Vertex’s Cystic Fibrosis Combo Meets Primary Endpoints in Two Late-Stage Studies

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from two Phase 3 studies of the tezacaftor (VX-661) / ivacaftor combination treatment that showed statistically significant improvements in lung function (percent predicted forced expiratory volume in one second, or ppFEV1) in people with cystic fibrosis (CF) ages 12 and older …

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FDA Approves Genentech’s Ocrevus for Relapsing and Primary Progressive Forms of Multiple Sclerosis

South San Francisco, CA — March 28, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The …

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Tesaro’s PARP Inhibitor Zejula Wins FDA Approval for Treatment of Ovarian Cancer

WALTHAM, MA, March 27, 2017 – TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEJULA™ (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary …

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Ziopharm Announces Successful End-of-Phase 2 Meeting with FDA for its Gene Therapy in Recurrent Glioblastoma

BOSTON, March 27, 2017 (GLOBE NEWSWIRE) — ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new immunotherapies, today announced the receipt of positive guidance from an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) for its lead gene therapy product candidate, Ad-RTS-hIL-12 plus orally administered veledimex …

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Genetics Reveal Mysteries of Hard-to-Treat Bacterial Infection in Cystic Fibrosis

New UBC research on bacteria that cause major problems for those with cystic fibrosis reveals clues as to how it proliferates for so long in the lungs and offers new ideas for treatments to explore. “Someone with cystic fibrosis has about one less teaspoon of water in the mucous in …

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The Skin Cancer Screening Paradigm; Reviewing Current Guidelines for Detecting Melanoma

The Future Science Group (FSG) journal Melanoma Management, today announces the publication of a new perspective article, in which over 50 leaders in the dermatology field critically assess current screening practice for melanoma in the US. Presently, the safest and most cost-effective method of screening for melanoma, a deadly form …

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Akashi Announces FDA Gives Okay to Resume Clinical Development of its DMD Drug

CAMBRIDGE, Mass., March 22, 2017 – Akashi Therapeutics, Inc. a clinical stage biopharmaceutical company developing treatments for patients with Duchenne muscular dystrophy (DMD), today reported that the U.S. Food and Drug Administration (FDA) has completed its review and concluded that Akashi may resume clinical development of HT-100 (delayed-release halofuginone) in …

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