BioSpace News Archive

Drug Development

Positive AML Data Propels Actinium’s Pipeline as it Preps for BLA

Monday, Actinium Pharmaceuticals released promising results Monday from a Phase III trial studying its lead radiotherapy candidate, Iomab-B, for patients with relapsed or refractory AML.

October 31, 2022
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3 min read
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Kate Goodwin
Business

Janssen Steps Away from Phase I Prostate Cancer Study, Cites Patient Enrollment Issues

ESSA confirmed that Janssen has stepped away from a prostate cancer collaboration due to “operational recruitment challenges.”

October 31, 2022
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2 min read
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Alex Keown
Drug Development

ASN to Spotlight Debate around Ardelyx’s Embattled CKD Drug

On Nov. 16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to discuss the relative merits of Ardelyx’s tenapanor in chronic kidney disease.

October 31, 2022
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5 min read
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Alex Keown
Policy

CytoDyn Yanks BLA Submission for Leronlimab in HIV, Blames CRO

CytoDyn withdrew its pending Biologics License Application for leronlimab in HIV, citing concerns involving the contract research organization managing its trials.

October 31, 2022
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3 min read
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Alex Keown
Business

Replay Launches Eudora to Target Genetic Retinal Diseases (Updated)

Platform technology company Replay, based in San Diego and London, has launched Eudora, a gene therapy company targeting genetic diseases of the retina.

October 31, 2022
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2 min read
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Mark Terry
Business

AbbVie Drops Autoimmune Candidate, Prioritizes Skyrizi and Rinvoq

While reporting stellar third-quarter financials, AbbVie announced it was halting development of cedirogant and provided updates on Skyrizi, Rinvoq and Humira.

October 31, 2022
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3 min read
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Mark Terry
Business

Sanofi, Alnylam Q3 Reports Hint at Early Pipeline Impacts from IRA

The implications of the Inflation Reduction Act of 2022 (IRA) are beginning to show as Alnylam drops the Stargardt indication for vutrisiran and Sanofi’s CEO reassures investors.

October 31, 2022
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2 min read
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Heather McKenzie
Drug Development

Reviva Pharmaceuticals Announces Global Enrollment Update for Pivotal Phase 3 RECOVER Study Evaluating Brilaroxazine for Schizophrenia

Reviva Pharmaceuticals Holdings, Inc. today announced over 30% enrollment in the United States, and initiation and ongoing enrollment across sites in Europe for the pivotal Phase 3 RECOVER study evaluating brilaroxazine for the treatment of schizophrenia.

October 31, 2022
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4 min read
Drug Development

Dyne Therapeutics Receives FDA Fast Track Designation for DYNE-251 for the Treatment of Duchenne Muscular Dystrophy

Dyne Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for DYNE-251 for the treatment of Duchenne muscular dystrophy (DMD) mutations amenable to exon 51 skipping.

October 31, 2022
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7 min read
Genetown

Paratek Announces First Milestone Towards Creating a U.S. Manufacturing Supply Chain for NUZYRA® (omadacycline) under BARDA Project BioShield Contract

Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK) today announces the commercial availability of U.S.-produced NUZYRA® (omadacycline) tablets.

October 31, 2022
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5 min read