Markets & Regulations

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Positive pre-IND meeting with FDA for new ovarian cancer cell therapy

By Isabel Cameron

Cartherics, a biotechnology company developing immune cell therapies for the treatment of cancer, has completed a pre-investigational new drug (pre-IND) meeting with the FDA for a phase 1/2 clinical trial of its cell therapy product, CTH-401 for the treatment...

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AbbVie receives greenlight from NICE for blood cancer treatment

By Isabel Cameron

AbbVie has announced that the National Institute for Health and Care Excellence (NICE) has recommended epcoritamab (tepkinly), its treatment for adults with diffuse large B-cell lymphoma (DLBCL), an aggressive and fast-growing blood cancer, whose cancer...

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Merck's path toward pharmacovigilance transformation

By Isabel Cameron

At Veeva R&D and Quality Summit 2023, Bio Pharma Reporter caught up with Courtney Gilbert, senior director, business system management and innovation, PV operations and global process enablement, at Merck.

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Hired and retired: New appointments in the pharma industry

By Isabel Cameron

BioPharma Reporter and Outsourcing Pharma presents its latest round-up of the movers, shakers and key announcements in the pharma industry. From Stand Up To Cancer, Astraveus and KBI Biopharma, we break down the key changes.

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Samsung Biologics: How to overcome biopharma industry challenges

By Isabel Cameron

A rising demand for biologics means that biotech companies face a multitude of manufacturing challenges, but also plenty of opportunities. We spoke to Kevin Sharp, senior VP and head of sales at Samsung Biologics, to examine what is driving this demand...