Manufacturing and Production

The FDA has granted accelerated approval for Genmab and Seagen’s TIVDAK (tisotumab vedotin-tftv), the first and only approved antibody-drug conjugate (ADC) for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

The placement of TIVDAK into the FDA’s Accelerated Approval Program was based on data from the Phase II innovaTV 204 trial that evaluated tisotumab vedotin in 101 patients.

AstraZeneca has announced on Tuesday a $340 million plan to establish an active pharmaceutical ingredient (API) manufacturing facility for small molecules near Dublin, Ireland.

The new plant will allow for late-stage development and early commercial supply, adopting new technology that is designed to meet the needs of the company’s new medicines pipeline.

The deal was developed with the support of Ireland’s investment agency, IDA Ireland.

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Inhaler and medical device maker Vectura has been removed from pharma conferences Formulation and Delivery UK and Drug Delivery to the Lungs (DDL) following the company’s £1.1 billion takeover by tobacco company Philip Morris International (PMI). 

In a memo seen by The Times, DDL chairman, Gary Pitcairn, said: “The primary purpose of DDL is to support the science behind pulmonary delivery of drugs to treat respiratory diseases and we do not wish to be associated with PMI and the tobacco industry.”

On Monday the UK cancelled a deal with French vaccine maker Valneva worth up to €1.4 billion, and Health Secretary Sajid Javid has now said that this was due in part to the belief the vaccine would not have gained MHRA approval.

Read: Valneva COVID-19 vaccine deal pulled by UK government

The Scottish Medicines Consortium (SMC) have recommended the use of Galapagos UK’s JYSELECA® (filgotinib) for eligible patients with severe active rheumatoid arthritis (RA). The once-daily oral drug is now available across Scotland on the NHS.

Filgotinib was shown to significantly increase the proportion of RA patients going into remission. Across the Phase III studies the drug improved the chance of disease remission, noting a DAS28-CRP score of <2.6, which indicates few or no symptoms.