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The May 2018 issue of Pharmafocus is now live!

Just in time for the first good weather of the year, the May 2018 edition of Pharmafocus is available to read online now!

Veeva R&D Summit, Europe

MHRA bans sodium valproate in the UK following birth defect controversy

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.

Lilly’s arthritis drug hits trouble at FDA committee

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.

AZ’s combo woes continue, with failure in lung cancer

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.

Prothena collapses on double trial failure

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.

Living with atrial fibrillation

Published on 23/04/18 at 11:05am

Tony Green discusses the difficulty in pinning down his diagnosis of the irregular heart rhythm condition, until his use of AliveCor’s KardiaMobile smartphone ECG device, at the recommendation of his cardiologist, proved to be a turning point on the way to better health.

How did your symptoms begin?

Top Ten most popular articles on Pharmafile.com this week

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.

The UK’s Royalties withholding tax consultation: Pushing extraterritorial boundaries

Published on 19/04/18 at 10:49am

Norton Rose Fulbright’s Dominic Stuttaford, James Baillieu and Susie Brain discuss the implications regarding the recent reforms to cross-border royalties.

The UK government has commenced a consultation regarding the scope of the royalty withholding regime applied in the UK. This may have a significant impact on multinational companies operating in the pharmaceutical sector who make UK sales other than through a UK permanent establishment or a UK tax resident entity.

Immunomedics’ whirlwind in the C-suite continues

Published on: 18/04/18

Immunomedics hasn’t had the most straight forward year, its $2 billion deal with Seattle Genetics was scuppered by activist investors, which eventually led to CEO, Cynthia Sullivan, and CSO, David Goldenberg, heading to the door.

Not long prior to this maelstrom, the company had lost its CFO, Peter Pfreundschuh, who decided to pursue other opportunities – ending up at Sucampo Pharmaceuticals, just before Mallinckrodt swooped to acquire it.

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