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Regulatory Editor Regulatory Editor

Roche Earns CE Mark for AI-Enabled Medical Device

Roche has received CE mark approval for its AI-enabled Accu-Chek SmartGuide continuous glucose monitoring (CGM) system, designed for adults with type 1 and type 2 diabetes on flexible insulin therapy. The system, which features a 14-day wear time and a one-step application process, uses predictive AI to provide real-time glucose predictions and assess hypoglycemia risk with clinical evaluations showing high accuracy, with 99.8% of glucose values within acceptable zones.

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Dealmaking Editor Dealmaking Editor

Thermo Fisher to Acquire Swedish Proteomics Firm

Thermo Fisher Scientific has announced plans to acquire Sweden-based Olink Holding AB for approximately $3.1 bn in order to leverage Olink’s validated protein biomarker targets and advanced proteomics solutions, including its Proximity Extension Assay (PEA) technology. The transaction is expected to close by mid-2024, subject to regulatory approvals and customary conditions.

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Strategy Editor Strategy Editor

Novartis Announces Closure of its San Diego Research Facility

Pharmaceutical Multinational, Novartis, has filed notice to close its San Diego R&D facility by mid-2025, eliminating 100 jobs. The facility, which is currently being used for oncology, neuroscience and immunology R&D, will be moved to other existing U.S. locations. The company says it plans to maintain a presence in San Diego.

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Expansion Editor Expansion Editor

CordenPharma to Invest €900 Million to Meet GLP-1 Drug Demand

CordenPharma has announced that it is investing €900 mn (c.$982 mn) over the next three years to expand its peptide manufacturing capacity in the U.S. and Europe, driven by rising demand for GLP-1 drugs. The Swiss CDMO plans to build a third facility and add new manufacturing lines to its Boulder, Colorado site, and construct a new large-scale manufacturing facility elsewhere in Europe.

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Strategy Editor Strategy Editor

Lonza Group Welcomes New CEO

Wolfgang Wienand has been announced as the new CEO of Lonza Group (starting July 1), succeeding Albert M. Baehny, who served as interim CEO since October 2023 and was Chairman of the Board until May 2024.

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Strategy Editor Strategy Editor

Lilly Looks to AI in Fight Against Drug-Resistant Bacteria

Eli Lilly has announced a partnership with OpenAI to leverage generative AI to invent novel antimicrobials to address drug-resistant pathogens and their worldwide impact on antimicrobial resistance.

The collaboration comes through the initiative of Lilly’s Social Impact Venture Capital Portfolio, with $100mn committed to provide patients with two to four new antibiotics by 2030.

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Regulatory Editor Regulatory Editor

FDA Expands Label for Sarepta’s Duchenne Gene Therapy

The FDA has broadened the label for Sarepta Therapeutics’ Elevidys - a gene therapy for Duchenne muscular dystrophy (DMD). The therapy is now approved for all DMD patients aged 4 and older after the therapy showed meaningful clinical benefits in secondary measures, despite the trial missing its primary endpoint.

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Strategy Editor Strategy Editor

Lupin Appoints CEO of New API CDMO Subsidiary

Indian multinational pharmaceutical company, Lupin, has expanded into the CDMO market.

The company has appointed Abdelaziz Toumi as the CEO of its newly established subsidiary, Lupin Manufacturing Solutions (LMS) which will focus on developing, manufacturing, and selling APIs while expanding into the CDMO market.

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