BioSpace News Archive

Herantis Pharma Expands on Timeline for Lymfactin Studies

Patient recruitment is expected to be completed in the first quarter of 2018 instead of by the end of 2017 as previously estimated and announced.

December 27, 2017

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3 min read

Policy

Eisai: Anticancer Agent Lenvatinib Designated for Priority Review and Approval by CFDA for Hepatocellular Carcinoma

The Priority Review and Approval procedure was implemented by the CFDA in February 2016 with the aim of accelerating research, development and launch of new medicines that have significant clinical value.

December 27, 2017

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4 min read

Sarepta Therapeutics and Nationwide Children’s Hos

Drug Development

Sarepta Shows Off Long-Term Pulmonary Function of Eteplirsen-Treated DMD Patients

A statistically significant and clinically meaningful reduction in pulmonary decline was observed for the eteplirsen-treated patients.

December 27, 2017

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6 min read

Business

HTG Molecular Diagnostics Expands its Collaboration With Merck KGaA, Darmstadt, Germany

The Master Collaboration Agreement complements the previously announced Master Companion Diagnostic Agreement with Merck KGaA.

December 27, 2017

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4 min read

Rezolute Enters Into Common Stock Purchase Agreement for Up to $10M With Lincoln Park Capital Fund, LLC

Proceeds from the Agreement will be used for operations and to advance the development of Rezolute’s product candidates and product collaborations.

December 27, 2017

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4 min read

Drug Development

Actinium Pharmaceuticals Provides Update on Pivotal Phase III Trial of Iomab-B: Independent Data Monitoring Committee Recommends SIERRA Trial Continue

Actinium expects enhanced awareness of Iomab-B at ASH annual meeting and expanded site activity to enable completion of trial enrollment by end of 2018, in-line with prior forecast.

December 27, 2017

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10 min read

Biotech Bay

Biotricity Closes a Registered Direct Financing and Paves the Way for Bioflux Launch

The gross proceeds from the offering will be approximately $2.5M before deducting estimated offering expenses.

December 27, 2017

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5 min read

Policy

Aeterna Zentaris Provides Update on Litigation Against David Dodd and Philip Theodore

The Company and its Chair consider the counterclaim against them to be entirely without merit, and intend to vigorously defend against the counterclaim.

December 27, 2017

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3 min read

Stryker Nabs FDA OK for Cementless Mako Total Knee

Policy

FDA Extends Review Date of Portola’s AndexXa BLA App

The FDA communicated that the action date will move from February 3, 2018 to May 4, 2018.

December 27, 2017

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3 min read

Biotech Bay

Kalytera Announces Approval of Shares for Services and Settlement of Debt Transaction With The Salzman Group of Israel

Under the deal, the TSXV has also approved, and the Company has completed, a settlement of certain debts previously owing through the issuance of Common Shares to The Salzman Group.

December 27, 2017

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4 min read