BioSpace News Archive

Policy

Nabriva’s Antibiotic Contempo Turned Down by FDA Over Manufacturing Issues

Nabriva Therapeutics announced that the Food and Drug Administration (FDA) had issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Contepo (Fosfomycin) to treat complicated urinary tract infections (cUTI), including acute pyelonephritis.

May 1, 2019
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3 min read
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Mark Terry
Policy

Charles River Labs Hit by Hackers, Some Client Data Compromised

The company disclosed the data breach in a filing with the U.S. Securities and Exchange Commission on Tuesday. The hacking occurred in March and the company said the data of about 1 percent of its total number of clients was compromised.

May 1, 2019
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2 min read
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Alex Keown
Pharm Country

BioSpace’s Global Biopharma Roundup: May 2

Pharma, biotech and life science companies from across the globe share data and progress on pipelines and other company events.

May 1, 2019
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4 min read
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Alex Keown
Business

Sydney’s AXT offers Organ-on-Chip systems in Asia Pacific region

Organ-on-Chip specialist CN Bio has signed a distribution agreement with Sydney-based AXT Pty. Ltd., Australia’s leading supplier of high technology scientific equipment.

May 1, 2019
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3 min read
Business

Apollomics, Inc. Appoints Fabio M. Benedetti, M.D. as Chief Medical Officer

Apollomics, Inc. announced that Fabio M. Benedetti, M.D. has joined the senior leadership team as Chief Medical Officer (CMO).

May 1, 2019
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3 min read
FDA

Medtronic Receives FDA Approval for World’s First Quadripolar Active Fixation Left Heart Lead

Attain Stability(TM) Quad MRI SureScan(TM) Lead Designed for Precise Placement and Stability

May 1, 2019
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3 min read
Deals

Codiak Biosciences Lines up for $86 Million IPO

The company is banking on investors approving of its approach to harness exosomes, which had once been considered the cells’ garbage cans, as a means of pioneering a new class of biologic medicines.

May 1, 2019
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2 min read
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Alex Keown
Business

Sandoz enters agreement for proposed trastuzumab biosimilar, currently in Phase III development, to treat selected HER2-positive cancer tumors

Collaboration covers proposed trastuzumab biosimilar in Phase III development for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric tumors

May 1, 2019
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7 min read
Pharm Country

Adult Congenital Heart Association Announces Funding of Organization’s Inaugural Research Grants

The six projects focus on important topics surrounding adult congenital heart disease.

May 1, 2019
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3 min read
Policy

AbbVie’s Mavyret Approved for Hep C in Pediatric and Adolescent Patients

The FDA gave the nod to AbbVie’s Mavyret for all six strains of hepatitis C in children ages 12 to 17 years. The drug was approved for adults 18 years or older in 2017.

May 1, 2019
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3 min read
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Mark Terry