BioSpace News Archive

TESARO Announces U.S. FDA Approval of VARUBI IV fo

FDA

NorthStar Scores FDA Approval to Make a Medical Isotope That Hasn’t Been Produced in US in More Than 25 Years

There has been no U.S. production of Mo-99, the parent isotope of Tc-99m, for more than 25 years.

February 9, 2018

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8 min read

Policy

Elite Pharma and SunGen Pharma File ANDA

Under the terms of the Agreement, the product will be owned jointly by Elite and SunGen.

February 9, 2018

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4 min read

Drug Development

Abeona Therapeutics Reports Top-Line Data from Phase I/II Gene Therapy Trial in MPS IIIA

Results were reported today during the WORLDSymposium for Lysosomal Diseases being held this week in San Diego, CA.

February 9, 2018

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7 min read

Biotech Bay

Relievant Announces Publication of Positive Outcomes in 12-Month SMART Sham RCT

The SMART Trial is a Level 1, randomized, sham-controlled, double-blind clinical trial for chronic low back pain whose rigor, size, and clinical outcomes are unprecedented in the field of spine care.

February 9, 2018

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4 min read

Biotech Bay

Dermira Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

The company granted RSUs representing an aggregate of 19,600 shares of Dermira common stock and stock options to purchase an aggregate of 254,075 shares of Dermira common stock.

February 9, 2018

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3 min read

Business

Corium Reports First Quarter Fiscal 2018 Financial Results and Corporate Highlights

Corium’s fiscal year ends on September 30.

February 9, 2018

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9 min read

Business

Chembio Diagnostics Announces Major New Tender Win and Certain Preliminary 2017 Financial Results

The Company expects shipments to begin during the second quarter of 2018.

February 9, 2018

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3 min read

Drug Development

Outcome From DSMB Safety Review and Extension of TACTI-mel Phase I Clinical Trial

In this first-in-man TACTI-mel Phase I clinical trial in Australia, efti is combined with pembrolizumab in unresectable or metastatic melanoma patients.

February 9, 2018

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2 min read

Policy

Pacific Biosciences Announces Outcome of First Phase of Patent Litigation Against Oxford Nanopore

The decision by the ITC is based on its interpretation that the term “single-molecule sequencing” is limited to sequencing-by-synthesis approaches, and that Oxford Nanopore’s sequencing approach is therefore not “single-molecule sequencing.”

February 9, 2018

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3 min read

Genetown

Two New Studies Demonstrate T2Candida’s Advantages over Current Diagnostic Testing

The study also demonstrates the ability of the T2Candida Panel to identify clinically important infections missed by blood culture, while dramatically shortening the time to treat an infection with targeted therapy.

February 9, 2018

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6 min read