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Structure Raises $300M as Oral GLP-1 Drug’s Data Keep Up With Pfizer, Eli Lilly

MedCity News

Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies.

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Liver injuries prompt clinical hold on Sanofi BTK drug

pharmaphorum

billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated. Those changes haven’t been enough to prevent the FDA from taking action, although outside the US the studies will continue as planned with the tighter safety monitoring.

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Bioinfogate becomes Clarivate

Clarivate

The move further expands and integrates drug toxicity data and translational safety intelligence from OFF-X into all aspects of the life science cycle. OFF-X is already integrated with several Cortellis products, including Cortellis Drug Discovery Intelligence and Cortellis Competitive Intelligence.

Safety 110
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Defining Biotech Success in a Challenging Fundraising Environment

PM360

With 2024 on the horizon, many in the biopharma space are taking stock of 2023 and what the current environment means for their potential success next year. This allows for a complementary portfolio fit without the kind of competitive overlap that comes under regulatory scrutiny from the FTC.

Biopharma 111
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Newron says pivotal treatment-resistant schizophrenia trial is a go

pharmaphorum

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. . ” The new data could accelerate partnering efforts of the drug this year.

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Interchangeability of biosimilars in the EU – the industry impact

European Pharmaceutical Review

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. For this reason, a unique ‘abridged’ procedure was introduced to provide a specific regulatory pathway for biosimilars in the EU.

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Clarivate Integrates Dialog Solutions Products and Services into Life Sciences & Healthcare Portfolio

Clarivate

The migration of these products and services into the Clarivate portfolio further bolster solutions that support pharmacovigilance medical literature monitoring, patent research, systematic review literature searches, MDR literature review searches, as well as competitive and business intelligence research.