BioSpace News Archive

BTG plc: Northwestern University Adopts Y90 TARE With TheraSphere as First-Line Treatment for HCC

BTG today announced that following positive results of its 15-year experience between 2003 and 2017 with TheraSphere, Northwestern University, Illinois has adopted Y90 TARE with TheraSphere as the primary trans-arterial LRT for patients with hepatocellular carcinomalimited to the liver.

December 12, 2017

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4 min read

Drug Development

TapImmune Announces Enrollment of First Patient in Phase II Clinical Trial for Treating Triple-Negative Breast Cancer Funded by U.S. Department of Defense

The 280-patient trial, sponsored by Mayo Clinic, received $13.3M in grant funding from the DoD to evaluate the prevention of cancer recurrence in women with TNBC who have completed first-line surgery and radiotherapy/chemotherapy.

December 12, 2017

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5 min read

Policy

Indivior Announces NDA Acceptance of RBP-7000 Risperidone Monthly Depot

Indivior today announces that the FDA has accepted the NDA for RBP-7000, an investigational, once-monthly injectable risperidone in the ATRIGEL delivery system for the treatment of schizophrenia.

December 12, 2017

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6 min read

Pharm Country

Only Generic for Kenalog-40 Injection Just Approved: Available Through Amneal Biosciences

Poised to launch, the product will be sold in 1 mL single-dose vials as well as in 5 mL and 10 mL multiple dose vials.

December 12, 2017

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2 min read

Policy

Alnylam Completes Submission of New Drug Application to the FDA for Patisiran for the Treatment of Hereditary ATTR (hATTR) Amyloidosis

The rolling submission began on November 15, 2017 with the nonclinical and chemistry, manufacturing and controls components submitted, and now submission of the clinical data completes the filing.

December 12, 2017

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10 min read

Drug Development

GlycoMimetics Reports Improvements in Median Overall Survival Versus Historical Matched Controls for Two AML Patient Subgroups in Phase I/II Trial for GMI-1271

This translational research provides important evidence that elucidates how treatment with GMI-1271 appears to be improving sensitivity to chemotherapy.

December 12, 2017

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7 min read

Business

Kaleido Biosciences Expands Leadership Team with Appointment of Alison Lawton as President and Chief Operating Officer

Ms. Lawton has more than 30 years of experience in a range of executive and operating roles in the biopharmaceutical industry.

December 12, 2017

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2 min read

Pharm Country

KVK Tech Launches First Mobile App

KVK Tech today announced the launch of its first mobile app, the LOMAIRA Daily Dose Tracker, available for Android and iOS.

December 12, 2017

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5 min read

Genetown

PAREXEL Launches Perceptive Cloud for the Life Sciences Industry

PAREXEL introduced the Perceptive Cloud to the life sciences industry, as part of the organization’s recent alliance with Microsoft Corp.

December 12, 2017

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3 min read

Policy

Portola Pharmaceuticals Provides Update on European Marketing Authorization Application for Betrixaban

The CHMP has provided the Day 195 List of Outstanding Issues (LoOI) to the company with a request for responses during the next available submission window of January 23, 2018.

December 12, 2017

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7 min read