Regulatory Index News: 17/04/2018

Welcome to your Regulatory Index News update today. The first patient has been treated with a novel gene therapy, positive clinical data has been reported for Tagrisso and Shire has sold off its oncology business.

Pfizer doses first patient with Bamboo’s muscular dystrophy gene therapy

Pfizer has administered its first dose of PF-06939926, a gene therapy acquired from Bamboo Therapeutics in 2016, to a patient within a clinical trial for Duchenne muscular dystrophy (DMD). The gene therapy is formed of an adeno-associated virus (AAV) capsid containing a human gene for a truncated dystrophin protein which naturally aids in keeping muscles intact. The phase 1b trial is aiming to enroll 12 patients in the hope that the therapy will be effective as a one-shot treatment for DMD by stopping or slowing muscle deterioration and weakness. The start of Pfizer’s trial has been welcomed by the Duchenne community, which are believed to be in real need of new treatment options beyond Exondys 51, a previously FDA-approved treatment. Please click here to read more from a FierceBiotech article.

AstraZeneca reports Tagrisso data to suggest a sustained benefit in lung cancer

AstraZeneca have now released data from their Phase 3 (FLAURA) trial which was assessing efficacy and safety of Tagrisso in first-line treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The data suggests that the drug provides benefit in progression-free survival (PFS) when compared to EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib. It was also noted that Tagrisso therapy had almost halved the risk of second progression or death when compared to the comparator line (EGFR-TKI). If you would like to read further, please click here for a PharmaTimes article.

Servier buys Shire’s oncology portfolio for $2.4 billion

Shire oncology unit has been acquired by Servier for $2.4 billion to access a number of their approved products such as Oncaspar and ex-US rights to Onivyde, as well as pipeline immuno-oncology collaborations and Calaspargase Pegal (Cal-PEG), an acute lymphoblastic leukaemia (ALL) treatment currently under US review. Shire consider the deal as a ‘key milestone’ after deeming that the business unit was not part of their long-term strategy where they will secure different opportunities. Servier on the other hand have said that the acquisition allows for establishment in the US and provides portfolio strength where they already operate. Please click here if you would like to read more in a PharmaTimes article.



Max Lymbery

Date Published

17th April 2018

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