BioSpace News Archive

FDA

FDA Releases Additional Framework for Development, Review and Approval of Gene Therapies

On June 11, 2018, FDA Commissioner Scott Gottlieb released a complementary framework for gene therapies, noting that in the last 12 months the agency has approved three different gene therapy products. “This reflects the rapid advancements in this field,” Gottlieb stated.

July 12, 2018
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2 min read
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Mark Terry
Pharm Country

High Blood Pressure Linked to Brain Lesions and Alzheimer’s in New Research

According to a new study published in Neurology, researchers discovered increased biomarkers for Alzheimer’s in the brains of older patients with high blood pressure.

July 12, 2018
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2 min read
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Alex Keown
FDA

DEA Moving Forward With Reclassification of CBD Ahead of GW’s Launch of Epidiolex

The U.S. Drug Enforcement Agency is in the midst of readdressing cannabis following the regulatory approval of the first cannabinoid-based drug for the treatment of some epilepsy patients.

July 12, 2018
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2 min read
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Alex Keown
Drug Development

Zogenix Still Chasing GW Pharma, but Epilepsy Drug Looks Good in 2nd Phase III Trial

Zogenix announced positive top-line data from its second confirmatory Phase III clinical trial of ZX008 (low-dose fenfluramine hydrochloride) for children and young adults with Dravet syndrome.

July 12, 2018
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2 min read
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Mark Terry
Drug Development

Compass Therapeutics Closes on Series A Financing Totaling $132 Million

Compass Therapeutics closed on the final $49 million of its $132 million Series A financing. The funds raised will be used to push their lead product, CTX-471 into the clinic as well as to identify two more clinical candidates by the end of this year.

July 12, 2018
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2 min read
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Mark Terry
Business

Dermavant Bags GSK Phase III-Ready Psoriasis Treatment in $330 Million Deal

Months after tapping GlaxoSmithKline dermatology division executive David Rubenstein as its new chief scientific officer, Vivek Ramaswamy’s Dermavant Sciences has returned to the pharma giant to acquire a Phase III-ready psoriasis treatment.

July 12, 2018
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2 min read
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Alex Keown
Business

Novartis to Drop Anti-Infectives Research Programs and Lay Off 140

The Novartis Institutes for BioMedical Research (NIBR) is ending its early-stage anti-infectives research programs located in Emeryville, California. As a result, the company expects to lay off about 140 employees.

July 12, 2018
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2 min read
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Mark Terry
Business

Genmab and Immatics Partner on Next-Generation T-Cell Bispecific Immunotherapies Program

Denmark-based Genmab A/S struck a discovery and development deal with Immatics Biotechnologies GmbH.

July 12, 2018
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2 min read
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Alex Keown
BioMidwest

A*STAR Institute and Mayo Clinic Identify Key Protein to Convert Skin Cells into Other Types of Cells

A*STAR’s Institute of Molecular & Cell Biology (IMCB) in Singapore, along with the Mayo Clinic, identified a key epigenetic protein called H3.3 that helps convert skin cells into other types of cells via cellular reprogramming.

July 12, 2018
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2 min read
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Mark Terry
Drug Development

New Preclinical Results on Onxeo’s AsiDNA™, First-in-Class DNA Repair Inhibitor, Point to Strong Synergy and Reversion of Tumor Resistance when combined to PARP inhibitors

AsiDNA™ combined with olaparib* more than doubled the complete response rate observed with olaparib alone in an in vivo model of triple negative breast cancer resistant to PARP inhibitors

July 12, 2018
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8 min read