BioSpace News Archive

FDA

Quidel Receives FDA Clearance, CLIA Waiver for Its Point-of-Care Sofia® 2 Lyme Fluorescent Immunoassay for Use with Sofia® 2 Instrument from Finger-Stick Whole Blood Specimens

Quidel Corporation announced today that it has received 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver from the United States Food and Drug Administration (FDA) to market its Sofia 2 Lyme FIA

August 30, 2018
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11 min read
Business

You’re In Good Hands: Hope Orthopedics selects Dr. Aaron Karlen

Hope Orthopedics of Oregon today announced the addition of orthopedic hand surgeon, Dr. Aaron Karlen to their Salem, Oregon clinic located at 1600 State Street. Dr. Karlen specializes in orthopedic hand, wrist and elbow care and will bring his expertise to Hope patients.

August 30, 2018
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1 min read
Business

RootPath Receives $7 Million Seed Funding for Next-Gen Immuno-Oncology

RootPath, headquartered in Cambridge, Massachusetts, announced a $7 million seed funding round. The financing was led by Sequoia China. Volcanics Venture, BV (Baidu Ventures) and NestBio Ventures participated.

August 30, 2018
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3 min read
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Mark Terry
FDA

Bayer Secures FDA Approval for Hemophilia A Treatment, Jivi

Hemophilia A patients have another treatment option. This morning the U.S. Food and Drug Administration gave the nod to Bayer AG’s new treatment, Jivi (BAY94-9027).

August 30, 2018
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2 min read
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Alex Keown
Drug Development

REGENXBIO Looks to Take CLN2 Gene Therapy Treatment Into the Clinic

Maryland-based REGENXBIO is expanding its gene therapy pipeline to include a new treatment for late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, one of the most common forms of Batten disease.

August 30, 2018
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2 min read
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Alex Keown
Business

Vertex and Machine Learning Company Genomics Plc Enter Three Year Collaboration

Cystic fibrosis drugmaker Vertex Pharmaceuticals forged a three-year collaborative deal with U.K.-based machine learning specialist Genomics plc to improve the discovery of targets for precision medicines.

August 30, 2018
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2 min read
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Alex Keown
Deals

Awash in Funding, Sutro Biopharma Files for $75 Million IPO

Only a month after raising $85.4 million in a Series E financing, Sutro Biopharma filed for an initial public offering (IPO). The company plans to raise $75 million with the IPO.

August 30, 2018
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3 min read
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Mark Terry
Policy

FDA Launches New Pilot Program for Complex Trial Design

The U.S. FDA announced a new pilot program aimed at stimulating the use of complex innovative clinical trial designs for drugs and biologics. Announced on Wednesday, August 29, the pilot program will continue through September 30, 2022.

August 30, 2018
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2 min read
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Mark Terry
Drug Development

Pfizer Terminates Two DMD Studies Following Data Review

Pfizer terminated two clinical studies evaluating domagrozumab (PF-06252616) for the treatment of Duchenne muscular dystrophy (DMD).

August 30, 2018
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2 min read
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Alex Keown
BioForest

August 31 Research Roundup: New Brain Cells, Regrowing Spinal Nerve Cells, Stunted Telomeres and the Planet Jupiter

There are plenty of great scientific research stories out this week. Here’s a look at just a few of them.

August 30, 2018
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6 min read
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Mark Terry