BioSpace News Archive

Business

Lisa Stockman Mauriello Receives First Tofersen Treatment - UPDATED

Phase one launched last week after patients who had been on placebo in Biogen’s pivotal phase III VALOR study were transitioned to active therapy.

July 23, 2021
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3 min read
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Heather McKenzie
Biotech Bay

Breakthrough Discovery on Molecular “Noise” Could Enhance Stem Cell Therapies

Scientists at Gladstone discovered a molecular mechanism that can manipulate random fluctuations, or “noise,” when stem cells transform into different other cells in the body.

July 23, 2021
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2 min read
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Vanessa Doctor, RN
BioForest

Clinical Catch-Up: July 19-23

It was another busy week for clinical trial updates. Here’s a look at some including Mesoblast Limited, CytoDyn, Magenta Therapeutics and more.

July 23, 2021
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6 min read
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Mark Terry
Drug Development

New Trial Data Call into Question Long-Term Efficacy of BioMarin’s Hemophilia A Gene Therapy

Updated trial data show patients treated with BioMarin Pharmaceutical’s severe hemophilia A gene therapy expressed substantially lower factor VIII levels after five years compared with one year, calling into question the drug’s long-term benefits.

July 23, 2021
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2 min read
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Brandon May
Drug Development

FDA Action Alert: Incyte, Iterum and Ardelyx

The U.S. Food and Drug Administration (FDA) had several PDUFA dates on their calendar for the last week of July, but in two cases, there were problems with the submissions ahead of time. Here’s a look.

July 23, 2021
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3 min read
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Mark Terry
Business

Long-Awaited Elizabeth Holmes Documentary Set to Air on Hulu After Fraud Trial Begins

As disgraced Theranos founder Elizabeth Holmes awaits her day in court, a long-awaited documentary series focused on the Stanford dropout who became a billionaire before losing it all is set to air on streaming service Hulu.

July 23, 2021
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3 min read
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Alex Keown
Business

Despite Slow Launch, Biogen Touts $2 Million In Early Sales for Alzheimer’s Drug

The company also issued an open letter to the Alzheimer’s disease community from Alfred Sandrock, which attempts to push back against negative media attention.

July 23, 2021
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5 min read
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Mark Terry
Drug Development

COVID-19 Surges in U.S., Lambda Variant and More Related News

With COVID-19 resurging in the U.S., particularly in states with the lowest vaccination rates, additional news and research about the vaccines and the virus is coming out. Here’s a look.

July 23, 2021
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3 min read
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Mark Terry
Drug Development

Adverum Down After Clinical Development Shift for Gene Therapy Program

Shares of Adverum Biotechnologies plunged more than 20% in premarket trading after the company announced it was revising its clinical development plan for investigational gene therapy candidate ADVM-022 based on safety concerns in patients with diabetic macular edema (DME).

July 23, 2021
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3 min read
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Alex Keown
Policy

Judge Orders Novartis to Cough Up $178 Million to Plexxikon Over Patent Infringements

Novartis claimed the patents held by Plexxikon were invalid. Unfortunately for the company, the jury found it was unable to prove these claims.

July 23, 2021
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2 min read
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Brandon May