BioSpace News Archive

Drug Development

Medivir Release: Successful Completion of Pre-clinical Safety Studies With MIV-818, Enabling Start of Phase I Clinical Studies in 2018

Medivir AB today announced the successful completion of the pre-clinical safety studies for MIV-818 to enable the start of phase I clinical trials in 2018.

January 8, 2018
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2 min read
FDA

Synapse Biomedical Inc. Receives CE Approval for TransAeris, the First Medical Device Approved for the Treatment of Ventilator Induced Diaphragm Dysfunction (VIDD)

TransAeris is a temporary diaphragm stimulator, for use in intensive care unit (ICU) patients on mechanical ventilation (MV).

January 8, 2018
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2 min read
Biotech Beach

HemaCare Announces OneBlood Exercises Second Investment Tranche Option

Under the terms of the agreement signed January 6, 2017, OneBlood is purchasing an additional 363,786 shares at $3.44 per share.

January 8, 2018
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2 min read
Business

Innovus Pharma Enters Into License and Distribution Agreement with Acerus Pharmaceuticals for the Commercialization of UriVarx in Canada

Under the agreement, Innovus Pharma will receive an up-front license payment and is eligible to receive up to CAD$1.65 million dollars in sales milestone payments plus minimum order quantities at an agreed-upon transfer price.

January 8, 2018
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7 min read
Business

NovaBay Pharmaceuticals Announces Preliminary Sales for 2017 Fourth Quarter and Full Year

Total revenue for the full year of 2017 is expected to be approximately $18 million, up 51% from 2017.

January 8, 2018
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4 min read
Policy

FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

Merck today announced that the FDA has accepted for review two New Drug Applications (NDAs) for doravirine, the company’s investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of HIV-1 infection in adults.

January 8, 2018
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7 min read
Drug Development

Merck’s Keytruda Significantly Improved Recurrence-Free Survival Compared to Placebo as Adjuvant Therapy in Patients With Stage 3 Resected High-Risk Melanoma

The safety profile of Keytruda in this trial was consistent with that observed in previously reported studies involving patients with advanced melanoma.

January 8, 2018
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26 min read
Policy

Ascentage Pharma Announces Acceptance of IND Application by China FDA for Clinical Study of Novel IAP Inhibitor to Treat Hepatitis B Infection

APG-1387 is the first IAP inhibitor to be studied in patients with HBV in China.

January 8, 2018
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4 min read
Genetown

Sage Therapeutics to Provide Pipeline Update at J.P. Morgan Healthcare Conference and Outline Key 2018 Initiatives to Support Planned Evolution to a Fully-Integrated Commercial Biopharmaceutical Company

Sage Therapeutics today announced that in a corporate presentation at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco.

January 8, 2018
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9 min read
Acasti Pharma Announces Issuance of Common Shares in Payment of Outstanding Interest Under Debentures

Acasti announces that in accordance with the terms of its outstanding convertible debentures in the total aggregate principal amount of $2,000,000 issued on February 21, 2017.

January 8, 2018
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3 min read