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International regulation: the importance of quality assurance in drug development

European Pharmaceutical Review

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work.

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Six Biosimilars Part of EMA’s Authorization Recommendations in June

PharmaTech

Zemcelpro is used to treat patients that require allogeneic hematopoietic stem cell transplantation following chemotherapy or radiotherapy when no other type of suitable donor cells is available. Two generic drugs were also approved.

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PROTAC development gains momentum, but clinical performance is poor

Pharmaceutical Technology

This makes early R&D less risky, as many lead compounds are discontinued due to inadequate pharmacokinetic profiles and require excessively high dosages to be pharmaceutically active. Faslodex will be administered in the control arm of the Phase III study, allowing for direct comparison between the two ER degraders.

Dosage 59
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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

The availability of oral chemotherapy treatments would provide stomach cancer patients with the option of more efficacious drugs with improved tolerability in a more convenient dosage format” The poor clinical outcomes of stomach cancer make it a key target for drug development.

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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years.

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CAR T and Beyond: The Expanding Pipeline and Promise of Cell Therapies

Pharmacy Times

SHOW MORE With robust pipelines, cell therapy remains the major driver for drug development. The field is expanding into autoimmune diseases, with nononcology trials representing 51% of the pipeline by late 2024. Trends Pharmacol Sci. 2024;45(5):406-418. doi:10.1016/j.tips.2024.03.004