BioSpace News Archive

Drug Development

New Data from Zogenix’s Phase III Trial of ZX008 in Dravet Syndrome (Study 1) and Findings on Disease Impact to be Presented at 71st American Epilepsy Society Annual Meeting

These posters will be presented at the 71st American Epilepsy Society (AES) Annual Meeting, which will take place at the Washington Convention Center in Washington, D.C., from December 1-5, 2017.

November 21, 2017

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6 min read

Policy

Novelion Therapeutics Provides Update on Agreement Between Aegerion Pharmaceuticals and U.S. Department of Justice

The Company, in consultation with its outside counsel, is currently evaluating its options and next steps.

November 21, 2017

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1 min read

FDA

Teligent Announces FDA Approval of Erythromycin Topical Solution USP, 2%

This is Teligent’s eighth approval for 2017.

November 21, 2017

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2 min read

Business

Auris Medical to Report Third Quarter 2017 Financial Results and Provide Business Update on Tuesday, November 28, 2017

Following the announcement, Auris Medical’s management team will host a live conference call and webcast at 8:00 am Eastern Time.

November 21, 2017

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1 min read

Drug Development

Catalyst Pharmaceuticals Announces Phase II Study of Firdapse in Ambulatory Patients With Spinal Muscular Atrophy (SMA)

The study will be conducted by a team of researchers led by Lorenzo Maggi, MD, and Giovanni Baranello, MD, of the Fondazione Istituto Neurologico Carlo Besta in Milan, Italy, a major referral center for SMA patients.

November 21, 2017

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7 min read

Business

Genmab Announces Submission of Supplemental Biologics License Application to FDA for Daratumumab in Front Line Multiple Myeloma

In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

November 21, 2017

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7 min read

BioMidwest

DiaMedica Accelerates Warrant Expiry Date

Any warrants not exercised prior to the accelerated expiry date and time will expire without any further action being taken.

November 21, 2017

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3 min read

BioMidwest

Life Spine Announces Alpha Launch of SIMPACT TRI-FIN Sacroiliac Joint Fixation Screws

The SIMPACT TRI-FIN system was designed with an anti-rotational sleeve to inhibit component back out, and a screw thread design which affords the surgeon the ability to compress and stabilize the SI joint.

November 21, 2017

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2 min read

Policy

Illumina Wins Infringement Suit Against Premaitha Health and Ariosa Diagnostics

The Court found that Premaitha’s IONA test infringed EP 1 981 995, EP 2 385 143, EP 2 183 693 and EP 2 514 842, which are generally directed to the use of sequencing in non-invasive prenatal testing (NIPT).

November 21, 2017

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1 min read

Policy

U.S. Stem Cell Responds to FDA’s Regenerative Medicine Guidelines

The framework is described among four FDA guidance documents that build upon its existing, risk-based regulatory approach, that further describes regulation of drugs, devices, and/or biological products.

November 21, 2017

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4 min read