BioSpace News Archive

Drug Development

FibroGen Continues Losing Streak with Phase III DMD Failure

The company’s pamrevlumab has failed another late-stage study in Duchenne muscular dystrophy, unable to significantly improve functional motor abilities over placebo.

August 30, 2023
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2 min read
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Tristan Manalac
Policy

FDA Denies Outlook’s Wet AMD Bid, Issues Complete Response Letter

Citing lack of evidence and manufacturing issues, the regulator has rejected Outlook Therapeutics’ bid to have its bevacizumab formulation approved for wet age-related macular degeneration.

August 30, 2023
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2 min read
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Tristan Manalac
Skills Gap Could Hinder Advances in Cell and Gene Therapies

The current workforce lacks the skills to move these biological treatments through the regulatory and production pipeline, a new report finds.

August 30, 2023
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4 min read
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Stacy Kish
Policy

Deep Dive: Inflation Reduction Act

In this special report, BioSpace examines how the biopharma industry is grappling with impending consequences of the Inflation Reduction Act.

August 30, 2023
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3 min read
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BioSpace Editorial Staff
Business

Franz-Werner Haas: Learning Lessons Is the Best Lesson of All

As the new CEO of LimmaTech Biologics, Haas’ IP and legal background sets him apart to lead the charge for the team’s bacterial vaccine pipeline.

August 30, 2023
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4 min read
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Karen Fischer
Drug Development

New Biomarker Tests Aid Quick, Accurate Diagnosis of Alzheimer’s Disease

With new Alzheimer’s drugs receiving—and expected to receive—FDA approval, the market for diagnostic biomarker tests is set to expand.

August 30, 2023
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6 min read
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Claire Jarvis
Policy

Pfizer, BioNTech Challenge Moderna’s COVID-19 Patents with USPTO

In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.

August 30, 2023
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2 min read
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Tristan Manalac
FDA

Opinion: Regulators Legitimize Decentralized Trials with New Draft Guidances

However, a lack of regulatory harmonization risks undermining the effective implementation of these technology-driven approaches.

August 30, 2023
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4 min read
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Pamela Tenaerts
Deals

Novo Bolsters Obesity Pipeline with Potential $500M Embark Biotech Buy

This is the Danish company’s second obesity-focused acquisition in three weeks. Under the deal, Novo Nordisk receives the full rights to develop and commercialize Embark’s lead metabolic platform.

August 30, 2023
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2 min read
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Kate Goodwin
argenx to Present at Upcoming September 2023 Investor Conferences

argenx announced that members of management will participate in several upcoming investor conferences in September:

August 30, 2023
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1 min read