Manufacturing and Production

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced that sodium valproate, a drug used in the treatment of epilepsy and bipolar disorder which is sold by Sanofi under the brand Depakine and Depakote/Depamide respectively, has been banned in the UK as aconsequence of its links to birth defects in children. It will now only be available under a special pregnancy prevention programme.

FDA’s advisory committee were openly conflicted about deciding on the safety of Eli Lilly and Incyte’s drug, baricitinib, for the treatment of rheumatoid arthritis (RA).

The drug had initially been rejected by the FDA in April of 2017, citing the lack of data on safety and to determine the correct dosage. It then performed an about-turn, allowing Lilly to reapply for approval.

Somewhat predictably, the same issues arose again during the discussions of the drug – despite Lilly offering additional data.

AstraZeneca has been hit by a fresh blow in its search for an immunotherapy combination treatment that could differentiate it from its rivals, after a trial in patients with locally-advanced or metastatic non-small cell lung cancer, who had received at least two treatment prior treatments, failed to meet its mark.

The trial tested Imfinzi alongside tremelimumab but the combination, just as in the notorious Mystic trial, failed to hit its endpoints.

Shares in Prothena have dropped by close to 70% on the news that two of its trials into its lead drug candidate, NEOD001, had both missed the mark.

The biotech has revealed that it will end development of the candidate, as they see no future for the investigational antibody in the treatment of AL amyloidosis.

The decision was reached based on the candidate missing its endpoints in a Phase 2b trial, and then a futility analysis revealing that there was no reason to pursue further investigation in its Phase 3 trial.

It's the end of another week and there's really been one story that has dominated the headlines – Takeda’s potential takeover of Shire. It should come as no surprise that our most viewed story of the week relates to the purchase.