Susvimo, a PDS version of the blockbuster Lucentis, is a refillable eye implant that will extend Roche's commercial opportunity in wet-AMD but presents training challenges. Pricing is slightly below Lucentis.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Analysts expected at least $12m in third quarter sales, but the Alzheimer’s therapy brought in just $300,000. The company says educating doctors and procuring a coverage determination from CMS – not lower pricing – are key to growth.  

Execs told Scrip they hope to get Tyrvaya (varenicline) onto formularies and aim for pricing that would make its nasal spray competitive with Restasis and Xiidra.

With the latest Delta variant wave in the rear-view mirror, vaccine and antiviral sales, and their impact on full-year guidance, are likely to remain the big swing factors in third-quarter earnings season.

Gilead looks set to expand its lead position in the triple-negative breast cancer (TNBC) market in Europe with a positive opinion for Trodelvy from the CHMP.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Although the label’s PD-L1 expression requirement could limit the addressable market, there is also potential for future combination with Seagen’s recently approved Tivdak.

Given the requirement for patients to have a Ki-67 score of at least 20%, the challenge now is to alter physicians’ thinking around Ki-67 testing, execs told Scrip.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

ChemoCentryx gets US approval of Tavneos for ANCA vasculitis, which it says may gradually ramp up to a blockbuster revenue opportunity. Current steroid-heavy standard of care has many drawbacks.

The company pre-announced $136m in third quarter sales, beating analyst consensus and signaling both increased oral CGRP inhibitor market share and improved per-prescription net revenue.