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Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug

MedCity News

But Neumora remains on track with its lead program, a different drug in late-stage clinical testing for major depressive disorder. The post Preclinical Safety Signal Prompts FDA Clinical Hold on Neumora Schizophrenia Drug appeared first on MedCity News.

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J.P. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer

MedCity News

With cancer as its initial focus, the startup contends its approach could offer safety and efficacy advantages compared to currently available targeted therapies. Morgan Leads $100M Financing for Startup’s R&D of Covalent Biologic Drugs for Cancer appeared first on MedCity News. The post J.P.

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Safety Risks and FDA Hold Lead Gilead to Stop Work on Drug in Blood Cancers

MedCity News

Gilead Sciences said an independent review of interim Phase 3 data found the immunotherapy, magrolimab, led to a higher risk of death. Though Gilead is discontinuing further development of the drug in blood cancers, a review is ongoing in solid tumors.

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Leading speciality pharmacies in pharma

Pharmaceutical Technology

The speciality drug channel participants, including speciality pharmacies, biopharma companies, and distributors, are transforming their operations with automated and secure data systems and next-generation analytics, which will improve data collection, partner performance and strategy effectiveness. Discover the top speciality pharmacies.

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Innovation in pharma manufacturing quality systems

European Pharmaceutical Review

For young biotechs, scaling up production brings green-field challenges, while for more established pharma a shift may be required to ensure that facilities are optimised for new ways of working. So what might that look like? Making quality more integral to production. Embracing the spirit rather than the letter of regulations.

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Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

MedCity News

tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring. The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury.

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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 may best be achieved by large pharma companies, with their combined $200bn annual R&D budget, compared to smaller companies that are relying on external investment.

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