Markets & Regulations

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GSK ups sales guidance on back of Shingrix strength

By Ben Hargreaves

GSK’s first quarter following the demerger of its consumer health business sees the company raise its 2022 sales guidance to between 6-8%, up from 5-7% on its previous estimation.

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FDA reviewing higher dose Hyrimoz biosimilar

By Jane Byrne

The US FDA has accepted a supplemental biologics license application (sBLA) from Sandoz for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar, Hyrimoz.

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Vertex to acquire ViaCyte, targeting type 1 diabetes

By Rachel Arthur

Vertex Pharmaceuticals will acquire ViaCyte, a privately held biotech focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320m.

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Kite secures third approved cell therapy indication in Europe

By Jane Byrne

The European Commission (EC) has approved Kite’s CAR T-cell therapy, Yescarta, (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

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Pfizer invests $95m in Valneva

By Rachel Arthur

Pfizer will invest €90.5m ($95m) in French vaccine specialist Valneva, representing 8.1% of Valneva’s share capital. The investment will support the duo’s Lyme disease vaccine partnership.

Pharma industry slams WTO move on TRIPS waiver

Pharma industry slams WTO move on TRIPS waiver

By Jane Byrne

Pharma industry organizations say they are deeply disappointed by the decision taken by World Trade Organization (WTO) at its ministerial conference, MC12, to endorse a TRIPS waiver for COVID-19 vaccines.