BioSpace News Archive

Biotech Beach

Sientra Launches New miraDry fresh Protocol for the miraDry® System at American Academy of Dermatology Annual Meeting

The miraDry treatment is the first and only FDA-cleared solution to permanently reduce underarm sweat, odor and hair of all colors with as little as one treatment, in one hour with immediate results.

February 16, 2018

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5 min read

Business

Arcturus Therapeutics Comments on Amended 13D Filing

As part of the amended 13D filing, Mr. Payne has proposed to nominate four director candidates and requested to convene an extraordinary general meeting.

February 16, 2018

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4 min read

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

FDA

Photocure Wins FDA Approval of New Indications for Blue Light Cystoscopy With Cysview

The approval of this new indication is based on the results from a large Phase 3 study.

February 16, 2018

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6 min read

Bio NC

Merz North America to Highlight Treatments at American Academy of Dermatology Annual Meeting

Merz North America announced today that Merz aesthetics products including Xeomin, Cellfina, Radiesse, Ultherapy and DeScribe PFD Patch will be featured in oral and online ePoster presentations at the American Academy of Dermatology (AAD) annual meeting in San Diego, CA, taking place February 16-20, 2018.

February 16, 2018

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9 min read

Policy

Akcea Announces FDA Advisory Committee Meeting to Review Volanesorsen as a Treatment for Familial Chylomicronemia Syndrome

The meeting is tentatively scheduled for May 10, 2018. Volanesorsen is an investigational therapy for the treatment of a rare lipid disorder called familial chylomicronemia syndrome (FCS).

February 16, 2018

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4 min read

BioMidwest

JAMA Oncology Publication Demonstrates Myriad Genetics’ EndoPredict (EPClin) Significantly Outperforms Oncotype DX Recurrence Score in Early-Stage Breast Cancerge Breast Cancer

A key finding is that Myriad’s EndoPredict (EPClin) significantly outperformed Oncotype DX® Recurrence Score at predicting the risk of disease recurrence in patients with early-stage breast cancer.

February 16, 2018

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9 min read

Business

Promore Pharma Regains Rights for PXL01 Manufacturing

Promore Pharma today announced that it will assume responsibility for the manufacturing of the investigational medicinal product for the clinical Phase III trial for PXL01 and at the same time, the company regains the global manufacturing rights for the commercial product.

February 16, 2018

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5 min read

Arch Biopartners Closes Convertible Note Financing

The Note matures on February 28, 2021 and will be convertible, at the option of the holder, into common shares in the capital of the Company at a price per Common Share of $0.60.

February 16, 2018

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3 min read

Pharm Country

amfAR Renews Investment in Bioengineering Approaches to Curing HIV

Totaling nearly $1M, the Investment grants will allow two collaborative teams of HIV researchers and bioengineers to embark on a second phase of projects initiated with amfAR funding awarded in February 2017.

February 16, 2018

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3 min read

Drug Development

Xeris Pharmaceuticals Achieves Phase III Milestones of its Ready-to-Use Glucagon Rescue Pen for the Treatment of Severe Hypoglycemia

Xeris has successfully completed two Phase 3 clinical studies of its investigational ready-to-use glucagon rescue pen (adult study: NCT02656069; pediatric study: NCT03091673).

February 16, 2018

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4 min read