BioSpace News Archive

FDA

Sunovion Announces FDA Acceptance of New Drug Application for Apomorphine Sublingual Film (APL-130277)

Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277)

June 12, 2018
·
6 min read
Job Trends

First Complete Prenatal Vitamin Shot Replaces Hard-To-Swallow Pills

eauLife North America LLC announced the launch of glë®, 3oz liquid prenatal vitamin shots,

June 12, 2018
·
2 min read
Policy

Ascletis Receives NDA Approval from China FDA for Ganovo

Ascletis announced that China Food and Drug Administration (CFDA) has approved its Category 1 new drug, Ganovo (also known as Danoprevir or ASC08), for the treatment of viral hepatitis C.

June 12, 2018
·
2 min read
Pharm Country

Clinical Data Highlighting Single-Cell Polyfunctionality as a Potential Predictor of Patient Response to CAR-T Cell Therapy Published in “Blood”

IsoPlexis Corporation (IsoPlexis) today announced the publication of clinical data demonstrating a significant association between the functionality of anti-CD19 CAR-T cell product before treatment, as defined by IsoPlexis’ Polyfunctional Strength Index (PSI), and the objective response in patients with non-Hodgkin lymphoma.

June 12, 2018
·
2 min read
Deals

PAVmed Closes Oversubscribed Rights Offering for Gross Proceeds of $10,350,000

PAVmed Inc. announced the closing of its oversubscribed equity subscription rights offering (the “Rights Offering”), which raised the maximum gross proceeds of $10,350,000.

June 12, 2018
·
5 min read
Business

Kewaunee Scientific to Report Results for Fourth Quarter and Fiscal Year 2018 Release Date

Kewaunee Scientific Corporation announced that the Company plans to release its fourth quarter and fiscal year end 2018 financial results on Tuesday, June 26, 2018 after the close of trading.

June 12, 2018
·
2 min read
Deals

Surna Completes $1.2 Million Equity Offering

Proceeds to be used to repurchase founders’ shares and for working capital and general corporate purposes

June 12, 2018
·
5 min read
Drug Development

REGENXBIO Receives FDA Fast Track Designation for RGX-111 Gene Therapy for the Treatment of Mucopolysaccharidosis Type I

REGENXBIO Inc. (Nasdaq: RGNX), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RGX-111. RGX-11.

June 12, 2018
·
7 min read
Policy

WhiteHill Life Sciences Announces Patent Filing: “Synergistic Compositions and Methods of Achieving Homeostasis In Mammalian Systems”

Ronald Butler, CEO announces a patent filing with inventors Dr. Dale Brown, PhD CTO and Dr. Ira Hill, PhD Founder and Chairman.

June 12, 2018
·
2 min read
BioForest

Life Science Washington’s Inaugural East-West Summit

Life Science Washington’s Inaugural East-West Summit

June 12, 2018
·
2 min read