Friday Five - The week in review

Roche on form

Having secured earlier-than-expected US approval for Hemlibra last week, Roche then unveiled new Phase III data, which is primed to expand usage into all haemophilia A patients – initial approval being in those who have developed Factor VIII inhibitors.

See KOL Views Results: Leading haematologist outlines expectations for Hemlibra's launch trajectory and Physician Views Poll Results: On balance, Roche's Hemlibra poised to transform haemophilia A market

Roche also announced positive progression-free survival data from the IMpower150 trial, which is studying the combination of Tecentriq, Avastin and chemotherapy versus Avastin and chemotherapy in first-line metastatic non-small-cell lung cancer. Full results will be presented next month and although multiple questions remain unanswered, Roche is now set to emerge as a differentiated competitor to Merck & Co. in the first-line lung cancer market.

Furthermore, Venclexta – co-marketed by Roche and AbbVie – looks well positioned to become a standard-of-care therapy in relapsed/refractory chronic lymphocytic leukaemia (when combined with Roche's Rituxan), following publication of a late-breaking abstract ahead of next month's ASH congress.

Amsterdam wins on penalties

In a bid to host the European Medicines Agency post-Brexit, Amsterdam beat out Milan in dramatic circumstances this week; with votes tied, the Dutch city's name was pulled out a hat.

Amsterdam was the favoured location based on the EMA's own internal scorecard, which had indicated this move would allow the highest staff retention.

The onus, now a decision has been made, is to implement groundwork for the transition, with the UK hopeful it will continue to work closely with the EMA post-Brexit. The risk, argue industry leaders, is that Europe could lose ground to the US and China – Spotlight On: Brexit becomes a reality for pharma as EMA's future decided

Taking the pulse on digital medicine

Physicians appear encouraged by the concept of digital medicines; such as tablets that incorporate ingestible sensors allowing patients and caregivers to track when they have been taken. Otsuka Pharmaceuticals and Proteus Digital Health broke new ground recently when the FDA approved Abilify MyCite.

This week, we asked prescribers how they may use this drug and the future of digital medicine – Physician Views Poll Results: Digital medicines could be game-changing, in time and in the right indications

ViiV bulks up with Gilead in mind

Setting its stall out for a show-down with Gilead Sciences in the HIV market next year, ViiV Healthcare secured US approval for its two-drug regimen Juluca – a fixed-dose combination of the integrase inhibitor Tivicay and the non-nucleoside reverse transcriptase inhibitor Edurant – this week. ViiV – majority-owned by GlaxoSmithKline – used a priority review voucher to speed up the FDA's regulatory review of Juluca and secure approval ahead of Gilead's three-drug emtricitabine, tenofovir alafenamide and bictegravir combination, which is likely to reach the US market early next year. Gilead's drug is expected to compete with ViiV's own three-drug combination Triumeq and Juluca is designed to differentiate its portfolio.

We will be snap-polling HIV specialists shortly to ascertain what market impact Juluca will have; a key question being the trade-off between potentially fewer side-effects but increased risk of resistance with a two-drug regimen.

M&A on the wish-list for 2018

Given that 2017 was ushered in with a degree of considerable political uncertainly, the pharmaceutical and biotech sectors have performed admirably, aided by the FDA, which remains on course to deliver nearly 50 novel drug approvals by year-end. What has been missing is M&A activity, with Takeda's claim this week it is being priced out of additional deals particularly telling. In a bid to expand their presence beyond domestic borders, Japanese pharma has typically been willing to stretch its cash a little further. Takeda's $4.7-billion acquisition of Ariad Pharmaceuticals in early 2017 remains the second biggest pharma deal of the year.

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