BioSpace News Archive

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  Business

  Safety Concerns Cause Novartis to Hit the Brakes on Three Late-Stage Trials for Eye Drug Beovu

  The early termination of the Beovu trials places a damper on Novartis’ hopes of competing even further with Regeneron Pharmaceuticals’ retinal disease drug Eylea.

  June 1, 2021

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  2 min read

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  Brandon May
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  Drug Development

  FDA Approves BridgeBio-QED Therapeutics’ Targeted Liver Cancer Treatment Truseltiq

  The FDA approves Truseltiq for patients with previously-treated locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.

  June 1, 2021

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  3 min read

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  Mark Terry
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  Drug Development

  HALT: AB Science Announces Worldwide Voluntary Hold on Lead Compound Masitinib

  Inclusions and treatment initiation will be paused in all ongoing clinical studies until an investigation into the potential safety issue is complete.

  June 1, 2021

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  2 min read

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  Heather McKenzie
• 

  Drug Development

  May Was a Busy Month with Seven Biotech IPOs

  There were seven initial public offerings (IPOs) for biotech companies in the month of May. Here’s a look.

  June 1, 2021

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  4 min read

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  Mark Terry
• 

  Business

  Female-Founded and Funded Capsida Taps Swati Tole as Chief Medical Officer

  Newly entrenched in a leadership role within one of the most complex therapeutic spaces, Tole discussed the complexities of being both a woman and a woman of color in the biotech industry.

  June 1, 2021

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  4 min read

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  Heather McKenzie
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  MyMD Pharma Develops Low-Toxicity, Plant-Based TNF-α Regulator

  MyMD Pharmaceuticals’ TNF-α regulator may be able to be commercialized without the black-box warnings that accompany so many TNF-α therapies.

  June 1, 2021

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  4 min read

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  Gail Dutton
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  BioMark Receives $825K Grant to Develop Its Liquid Biopsy Assay for Lung Cancer Screening

  The overarching goal is to develop a low-cost, high-throughput test that will make early-stage lung cancer screening feasible and affordable for at-risk population.

  June 1, 2021

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  6 min read
• 

  Drug Development

  Sanofi Halts Kidney Disease Program Studying Venglustat Drug

  Sanofi said that the phase II/III trial studying venglustat in autosomal dominant polycystic kidney disease was scrapped because it “did not meet futility criteria.”

  June 1, 2021

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  2 min read

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  Brandon May
• 

  Drug Development

  Amgen Breaks Through as FDA Approves Lumakras for Elusive KRAS Mutation

  The FDA gave the green light to Amgen’s Lumakras under accelerated approval as a treatment for patients with KRAS mutation whose disease has worsened over time.

  June 1, 2021

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  3 min read

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  Alex Keown
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  Drug Development

  After CRL, Alkermes Wins FDA Approval for Schizophrenia Drug Lybalvi

  The newly approved drug, Lybalvi, is a once-daily oral antipsychotic drug that is both a maintenance monotherapy or for the acute treatment of manic or mixed episodes.

  June 1, 2021

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  2 min read

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  Alex Keown