BioSpace News Archive

Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase I/II Study of ARO-HBV

Pending approval, Arrowhead intends to proceed with AROHBV1001, a Phase 1/2 single-dose escalation study to evaluate the safety, tolerability, and pharmacokinetic effects of ARO-HBV in healthy adult volunteers

December 22, 2017

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3 min read

Policy

BioMarin Receives Anticipated Notification of PDUFA Extension for Pegvaliase BLA to May 28, 2018

In a notice received from the FDA, the PDUFA Goal Date for pegvaliase has been extended by three months to May 28, 2018.

December 22, 2017

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5 min read

Policy

Antares Pharma Provides XYOSTED Regulatory Update

Antares Pharma today announced that a written request for a Type A meeting, along with a comprehensive briefing document, have been submitted to the FDA, in response to the CRL received by Antares.

December 22, 2017

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5 min read

Viemed Commences Trading on the TSXV

The common shares of Viemed (the “Viemed Shares”) will commence trading on the TSX Venture Exchange (the “TSXV”) on December 22, 2017 under the stock symbol “VMD”.

December 22, 2017

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8 min read

Biotech Bay

Fluidigm Announces Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

Fluidigm today announced that the Compensation Committee of its Board of Directors, which is comprised entirely of independent directors, granted an equity award on December 15, 2017.

December 22, 2017

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2 min read

Genetown

Proteostasis Therapeutics Announces Completion of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

Net proceeds from this offering were approximately $42.9M, after deducting underwriting discounts and commissions and estimated offering expenses.

December 22, 2017

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4 min read

Xbrane Biopharma Largest Shareholder Serendipity Group Issues a Credit Facility Of SEK 50 Million to the Company

The Credit Facility can be utilized by the Company over a period of 18 months.

December 22, 2017

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2 min read

Rhizen Pharma Receives FDA Orphan-Drug Designation for Tenalisib (RP6530) for Treatment of Peripheral T-Cell Lymphoma

Rhizen Pharma today announced that the FDA has granted orphan-drug designation for the active moiety of Tenalisib, the Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, for treatment of PTCL.

December 22, 2017

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2 min read

Deals

Centinel Spine Completes Acquisition of Prodisc Assets

Centinel Spine is pleased to announce the acquisition of the worldwide assets of the prodisc Total Disc Replacement portfolio from DePuy Synthes The prodisc line of products are total disc replacement products with the longest history of use globally.

December 22, 2017

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3 min read

Business

Haemonetics Sets Date for Publishing Third Quarter Fiscal 2018 Results: February 6, 2018

Haemonetics announced that the Company intends to publish third quarter fiscal 2018 financial results at 6:00 am Eastern Time on Tuesday, February 6, 2018.

December 22, 2017

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1 min read