BioSpace News Archive

Teva Announces Updated Indication and Vial Presentation for GRANIX® (tbo-filgrastim) Injection in United States

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved GRANIX® (tbo-filgrastim) Injection for a new vial presentation and indication in pediatric patients 1 month and older.

August 6, 2018
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10 min read
FDA

HedgePath Pharmaceuticals Announces Positive FDA Feedback from FDA Type-C Meeting and Files Pre-NDA Meeting Request

FDA has confirmed HPPI’s clinical and regulatory pathway for SUBA BCCNS and provided further guidance for anticipated NDA submission

August 6, 2018
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5 min read
Genetown

Simoa Technology Unlocks Insights from Previously Obscure Biomarker

Neurofilament light chain (NfL) proves to be a transformative biomarker for understanding wide range of neurological conditions and advancing clinical trials

August 6, 2018
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5 min read
Biotech Bay

Kedalion Therapeutics Closes $5 Million Series A Financing Round

Kedalion Therapeutics, Inc. announced the completion of a $5 million Series A financing.

August 6, 2018
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1 min read
Policy

FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder

The U.S. Food and Drug Administration today issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD).

August 6, 2018
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6 min read
Business

Crunch Franchise Announces Its Newest Location in Waco, Texas

Crunch Franchise announced today the planned opening of a new 24,000-square foot, 24/7 gym with state-of-the-art equipment and amenities in Waco, Texas.

August 6, 2018
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2 min read
Business

AIT Bioscience’s Terri Pascarelli Recognized as a 2018 PharmaVOICE 100 honoree

AIT Bioscience, LLC Chief Executive Officer, Terri Pascarelli has been named among the 2018 PharmaVOICE 100 honorees.

August 6, 2018
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2 min read
iX Biopharma Announces Approval of First Capsule Sildenafil Drug for Treatment of Male Erectile Dysfunction in Australia

iX Biopharma Ltd. is pleased to announce that it has received the approval by Therapeutic Goods Administration, the regulatory authority in Australia, for a sildenafil drug delivered using an oral capsule for the treatment of male erectile dysfunction.

August 6, 2018
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4 min read
Business

Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium, Imperial Innovations and Oxford Biomedica Announce New Partnership to Develop First-in-Class Gene Therapy for Cystic Fibrosis

This new collaboration unites leaders in cystic fibrosis gene therapy, lentiviral development and production, and the treatment of respiratory diseases to develop the first gene therapy for cystic fibrosis.

August 6, 2018
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8 min read
BioMidwest

UNMC solves big data problem in EHRs

A modern genetic test for a cancer patient contains more information than ever before: Too much, in fact, for modern digital medical records.

August 6, 2018
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5 min read