| 06.30.21 | AstraZeneca posts once-weekly diabetes data; Roche's 6-month Lucentis implant nears approval

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Today's Rundown

AstraZeneca posts phase 3 data on once-weekly diabetes drug in adolescents FDA accepts Roche's 6-month Lucentis implant for priority review GSK puts long-acting injectables at heart of HIV growth plans, downplays threat of oral rival from Gilead and Merck Roche wins European approval for subcutaneous NMOSD drug Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge heads to trial

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AstraZeneca posts phase 3 data on once-weekly diabetes drug in adolescents

By Nick Paul Taylor

A phase 3 clinical trial of AstraZeneca’s extended-release diabetes drug Bydureon in adolescents has met its primary endpoint. The study tested a once-weekly formulation of the glucagon-like peptide-1 receptor agonist exenatide to support a planned filing for approval with the FDA.

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FDA accepts Roche's 6-month Lucentis implant for priority review

By Nick Paul Taylor

The FDA has accepted Roche’s Port Delivery System with ranibizumab (PDS) for priority review. Roche is seeking approval for the drug delivery implant to free patients with wet age-related macular degeneration from the need to undergo frequent eye injections.

GSK puts long-acting injectables at heart of HIV growth plans, downplays threat of oral rival from Gilead and Merck

By Nick Paul Taylor

GlaxoSmithKline has put long-acting injectables at the heart of plans to grow its HIV business. GSK is looking to transition to a portfolio built around cabotegravir to mitigate the loss of patent protection on dolutegravir and hold off a challenge from Gilead and Merck.

Roche wins European approval for subcutaneous NMOSD drug

By Nick Paul Taylor

The European Commission has approved Roche’s Enspryng in neuromyelitis optica spectrum disorder. Roche is looking to subcutaneous administration, which could support dosing at home, to differentiate Enspryng from Alexion’s Soliris in the EU.

Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge heads to trial

By Noah Higgins-Dunn

Viatris, the newly-formed company that combined Mylan and Pfizer's Upjohn unit late last year, said it's "pleased" with the Kansas federal court's decision to dismiss all claims related to the Racketeer Influenced and Corrupt Organizations Act, including charges against the company's former CEO Heather Bresch, in an ongoing class action case.

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