BioSpace News Archive

Drug Development

Moderna Expands Product Line, Global Efforts, with IAVI Partnership

Building on the success of its COVID-19 mRNA vaccine, Moderna, Inc. is partnering with the nonprofit scientific research organization IAVI to develop treatments and vaccines against global health threats.

April 7, 2022
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2 min read
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Mark Terry
Drug Development

At AAN, Janssen Shows IgG Levels are Effective Biomarker for Generalized Myasthenia Gravis Treatments

Janssen’s Phase II study of nipocalimab for generalized myasthenia gravis (gMG) shows that serum IgG levels can be used as a supportive biomarker to manage this disease.

April 7, 2022
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4 min read
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Gail Dutton
Genetown

Medicare Officially Restricts Coverage of Biogen’s Aduhelm

Shares of Biogen are falling in post-market trading after the U.S. government officially announced it will limit coverage of the company’s controversial Alzheimer’s drug Aduhelm to patients in clinical trials.

April 7, 2022
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3 min read
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Alex Keown
Drug Development

Acadia To Seek First-Ever FDA Approval in Rett Syndrome

The company presented an update on its Phase III LAVENDER study of trofinetide for Rett syndrome at the American Academy of Neurology’s annual meeting in Seattle.

April 7, 2022
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2 min read
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Vanessa Doctor, RN
Policy

Omicron Mutates Again as Companies Race to Develop Therapeutics, Vaccines

Global health officials are monitoring COVID-19 cases with an eye to identifying the emergence of new, potentially more deadly or more infectious variants. Read on for more details.

April 7, 2022
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3 min read
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Mark Terry
FDA

AAN Spotlight: Multiple System Atrophy, Migraine, ALS and Parkinson’s

The American Academy of Neurology Annual Meeting (AAN) was held virtually and in-person in Seattle from April 2-7. Here’s a look at some of the highlights.

April 7, 2022
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4 min read
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Mark Terry
Business

ENSEM Therapeutics Banks $67 Million in Search of New Drug Targets

Proceeds from the Series A will be used to further advance the company’s Kinetic Ensemble platform and accelerate its R&D pipeline.

April 7, 2022
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2 min read
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Alex Keown
Business

Sanofi Closes NY Kadmon Facility in Effort to Simplify Operations

Six months after acquiring Kadmon Holdings, pharma giant Sanofi is closing Kadmon’s New York facility. As part of the paring down, Sanofi is also laying off 25 employees at the location.

April 7, 2022
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2 min read
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Hannah Chudleigh
Drug Development

A Week After Anemia Drug Rejection, Akebia Lays Off 42% of Workforce

In a regulatory filing, the Cambridge, Massachusetts-based company indicated that it plans to “refocus its strategic priorities” and lay off 42% of its workforce.

April 7, 2022
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2 min read
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Mark Terry
Business

Navidea Biopharmaceuticals Announces New Senior Regulatory Consultant and Return of Former Director of Regulatory Affairs

Navidea Biopharmaceuticals, Inc. today welcomed Kenneth Berger, Ph.D., as Senior Regulatory Consultant, and the return of the Company’s former Director of Regulatory Affairs, Richard McFerron.

April 7, 2022
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5 min read