BioSpace News Archive

Stryker Nabs FDA OK for Cementless Mako Total Knee

Policy

FDA Accepts GW Pharma’s Epidiolex NDA With Priority Review for Lennox-Gastaut Syndrome and Dravet Syndrome

The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018.

December 28, 2017

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6 min read

Business

Flexpoint Sensor Systems Provides Q4 Insight and Outlook for 2018

Flexpoint Sensor Systems today announces Q4 2017 topline revenue is expected to show increase and position the company for a record breaking year with revenue contributions coming from multiple key market segments.

December 28, 2017

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3 min read

FDA Advisory Committee Scheduled to Review Lipocin

Drug Development

Odonate Therapeutics Announces Initiation of CONTESSA, a Phase III Study of Tesetaxel in Patients with Locally Advanced or Metastatic Breast Cancer

In patients with MBC, tesetaxel was shown to have robust single-agent antitumor activity in two, multicenter, Phase 2 studies.

December 28, 2017

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7 min read

Drug Development

Adverum Biotechnologies Doses First Patient in the ADVANCE Phase I/II Clinical Trial of ADVM-043 for A1AT Deficiency

The ADVANCE clinical trial is designed to evaluate the safety and protein expression following a single administration of ADVM-043, Adverum’s novel gene therapy candidate.

December 28, 2017

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5 min read

Drug Development

Innovate Biopharmaceuticals’ Dose Response Data for Larazotide Acetate Demonstrating Its Unique Mechanism of Action and Applications in Diseases Caused by Increased Intestinal Permeability

The data reveal a narrow dose response for larazotide with the higher doses showing inhibition.

December 28, 2017

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3 min read

Business

Integrity Applications Signs Distribution Agreement for its GlucoTrack Non-Invasive Glucose Monitoring Device in the Netherlands

The agreement became effective on December 22nd, 2017.

December 28, 2017

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5 min read

Shareholders Turn Down Tender Offer to Take BioCanCell Private

Approximately 5.9 million shares were necessary for the tender to be accepted.

December 28, 2017

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2 min read

Pharm Country

Cancer Genetics Receives Non-Dilutive Funding of $1.1M Through New Jersey Technology Business Tax Certificate Transfer (NOL) Program

The payment, received in December 2017, is net of administrative and sales expenses and fees associated with the program.

December 28, 2017

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3 min read

Business

PetVivo Hires Randy Wenthold to Replace David Masters as Chief Technical Officer

Mr. Wenthold has been involved with medical devices from a development, manufacturing, and division management role for over 25 years.

December 28, 2017

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3 min read

BioMidwest

Predictive Technology Group Announces Issuance of U.S. Patent for Method of Treating Endometriosis

The patent covers any treatment of endometriosis in women, whether symptomatic or not, having any one (or more) of approximately 1,400 endometriosis-associated midwegenetic markers.

December 28, 2017

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2 min read