BioSpace News Archive

Drug Development

Positive Feedback From FDA Significantly Benefits Ongoing NefIgArd Pivotal Phase 3 Study

Calliditas Therapeutics AB announced that it has obtained written feedback from the US Food and Drug Administration that will have a significant impact on the ongoing pivotal Phase 3 study, NefIgArd, with Calliditas’ leading drug candidate Nefecon for the chronic autoimmune kidney disease IgA Nephropathy.

September 3, 2019
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3 min read
Drug Development

Strekin AG Secures Financing to Complete Development of STR001 in Sudden Sensorineural Hearing Loss and to Prepare NDA Filing in Europe

Strekin AG announced that it has successfully closed a Series A financing round totaling CHF 2.82 Million from private investors.

September 3, 2019
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2 min read
Policy

Inotrem Announces Fast Track Designation Granted by U.S. FDA to Nangibotide Development Program for the Treatment of Septic Shock

Inotrem S.A. announced that the U.S. Food and Drug Administration has granted Fast Track designation to nangibotide development program for the treatment of septic shock.

September 3, 2019
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3 min read
BioMidwest

Elekta to Highlight Precision Radiation Medicine Solutions That Improve Patient Outcomes at ASTRO Annual Meeting

At the American Society for Radiation Oncology 2019 Annual Meeting, September 15-18 in Chicago, Elekta will highlight its growing portfolio of innovative solutions that are making Precision Radiation Medicine the new standard in value-based healthcare.

September 3, 2019
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2 min read
Arkivum Provides Pioneering e-Archive to Idorsia Pharmaceuticals Delivering GxP Compliant Long-term Access to Valuable Product and Clinical Trial Data

Arkivum announced that Idorsia Pharmaceuticals, headquartered near Basel, Switzerland; has selected Arkivum to safeguard and digitally preserve their valuable research and clinical trial data.

September 3, 2019
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3 min read
Policy

U.S. Drug Enforcement Agency to Expand Cannabis Research: GB Sciences Submitted One of Thirty-Three Applications to Become a DEA-Registered Cannabis Supplier to U.S. Marijuana Researchers

GB Sciences, Inc. announced that it has received notification from the U.S. Drug Enforcement Agency that prior to making any decisions on the pending applications, the DEA intends to distribute regulations that govern the program of growing marijuana for scientific research under DEA registration.

September 3, 2019
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3 min read
Job Trends

Jan and Dan Duncan Neurological Research Institute and Leica Microsystems Establish Center of Excellence in Microscopy

The Jan and Dan Duncan Neurological Research Institute at Texas Children’s Hospital and Leica Microsystems, Inc. combined efforts to establish the Leica Microsystems Center of Excellence at the NRI.

September 3, 2019
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4 min read
Business

Nickcola Wallace Joins HomeCare Connect as Complex Care Transition Manager

HomeCare Connect, which manages home health services in the workers’ compensation industry, has hired Michelle “Nickcola” Wallace, CAPS as Complex Care Transition Manager.

September 3, 2019
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2 min read
Business

Cidara Therapeutics and Mundipharma Form Strategic Partnership to Develop and Commercialize Rezafungin

Cidara Therapeutics, Inc. and Mundipharma announced that they have entered into a strategic partnership to develop and commercialize rezafungin for the treatment and prevention of invasive fungal infections.

September 3, 2019
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8 min read
Business

Velabs Therapeutics announces strategic partnership with alytas therapeutics to develop a novel immune-based therapy for obesity

Velabs Therapeutics GmbH announces that it has entered into a partnership agreement with alytas therapeutics GmbH, to jointly develop modulatory and functional antibodies for a novel immune-based therapy against obesity.

September 3, 2019
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3 min read