BioSpace News Archive

Researchers at Washington University Report DiviTum Can Evaluate the Biologic Activity of Blockbuster Breast Cancer Drug Ibrance After Just Two Weeks

Led by Dr Cynthia Ma, the study investigated 50 women with breast cancer treated with standard endocrine therapy in combination with Ibrance prior to surgery.

November 28, 2017
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2 min read
Policy

Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag NDA With Priority Review

The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is May 21, 2018.

November 28, 2017
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4 min read
Prima BioMed Becomes Immutep

The Company is pleased to advise that the name Immutep Limited has been formally adopted after ASIC registration.

November 28, 2017
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1 min read
The CNS Summit Announces Top 10 on 2nd Annual CNS Summit Innovation Index

The CNS Summit has released the 2017 CNS Summit Innovation Index.

November 28, 2017
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1 min read
Genetown

TESARO Announces Availability of VARUBI (rolapitant) IV for Delayed Nausea and Vomiting Associated With Cancer Chemotherapy in the United States

The U.S. Food and Drug Administration (FDA) approved VARUBI injectable emulsion on October 25, 2017.

November 28, 2017
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11 min read
GN Store Nord A/S: Transactions in Relation to Share Buyback Program – Nov. 28, 2017

The share buyback program has been initiated in order to reduce the company’s share capital and to cover obligations under the long-term incentive program.

November 28, 2017
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2 min read
Drug Development

Aptevo Therapeutics Announces Plans to Conduct Phase II Study of Otlertuzumab in Peripheral T-Cell Lymphoma

In addition, the company expects to file 2 Investigational New Drug (IND) applications in 2018 for 2 bispecific antibody candidates

November 28, 2017
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8 min read
Policy

Repro-Med Clears 2016 FDA Warning Letter, Shakes Up C-Suite

Repro-Med said the closure of the warning letter stemmed from its successful bid for 510(k) clearance for its Integrated Catch-Up Freedom Syringe Driver System, granted in September.

November 28, 2017
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3 min read
Business

Lexogen and Partek Deliver QuantSeq Analysis Solution

This pipeline enables Lexogen customers to import raw sequencing files directly into Partek Flow to automate analysis and removes the barrier for those without an advanced bioinformatics background.

November 28, 2017
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3 min read
Genetown

Voluntis to Integrate Insulia With Onduo Virtual Diabetes Clinic

The integrated solution will launch in pilot programs with US providers and payers in early 2018.

November 28, 2017
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3 min read