BioSpace News Archive

Policy

Karuna Secures FDA Decision Date for Schizophrenia Candidate KarXT

The regulator accepted Karuna Therapeutics’ NDA and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.

November 30, 2023
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2 min read
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Tristan Manalac
Drug Development

Artificial Intelligence, Part 2: Human Interaction, Liability, and Patient Safety

Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.

November 30, 2023
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1 min read
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BioSpace Insights
Drug Development

Opinion: The Transformative Potential of Gene Therapy for Neurodegenerative Diseases

For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape.

November 30, 2023
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4 min read
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William Chou
Policy

Samsung Bioepis, J&J Ink Settlement and License Deal for Stelara Biosimilar

The two companies have settled all pending U.S. patent litigation, clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of Stelara.

November 30, 2023
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2 min read
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Tyler Patchen
Deals

AbbVie Buys ImmunoGen in $10B Deal, Gains Access to ADC for Ovarian Cancer

Facing the loss of Humira revenues from biosimilar competition, AbbVie is looking to grow its pipeline by acquiring ImmunoGen and its antibody-drug conjugate Elahere, which was granted FDA accelerated approval last year.

November 30, 2023
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2 min read
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Tyler Patchen
Policy

Intas Pharmaceuticals Hit with Another FDA Warning Letter, Put on Import Alert

The troubled Indian pharma company received its second FDA warning letter in months, which this time cited quality control and data integrity lapses at its manufacturing facility in Gujarat, India.

November 30, 2023
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2 min read
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Tristan Manalac
Xenon Looks to Raise Cash for MDD Program with $300M Public Offering

Despite a recent Phase II miss, Xenon Pharmaceuticals is forging ahead with its candidate for major depressive disorder, offering 8.4 million common shares for sale.

November 30, 2023
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2 min read
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Kate Goodwin
ObsEva Announces Application for a Moratorium to Facilitate Pivotal Deals

ObsEva SA announced that, following a comprehensive assessment of the company’s financial position, the Board of Directors has opted to seek a moratorium from the competent court in Geneva, Switzerland.

November 30, 2023
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2 min read
Poolbeg Pharma PLC Announces Directorate Change

Poolbeg Pharma, a biopharmaceutical company focussed on the development and commercialisation of innovative medicines targeting diseases with a high unmet medical need, announces a change to its Board of Directors.

November 30, 2023
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3 min read
Business

Burning Rock Reports Third Quarter 2023 Financial Results

Burning Rock Biotech Limited, a company focused on the application of next generation sequencing technology in the field of precision oncology, reported financial results for the three months ended September 30, 2023.

November 30, 2023
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18 min read