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Approvals & Launches

Set Alert for Approvals & Launches

Roche’s Port Delivery System Approved, Paving The Way For Ophthalmology Expansion

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.

Approvals Launches

Pipeline Watch: Phase III Readouts In Breast And Liver Cancer Plus COVID-19

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.

Pipeline Watch Approvals

Biogen’s Q3 Aduhelm Sales Even Worse Than Expected

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.  

Launches Market Access

Oyster Point Prepares Major Push For New Dry Eye Drug

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.

Approvals Ophthalmic

Stock Watch: Third-Quarter Earnings Season – The New Endemic Normal

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.

Stock Watch Sales & Earnings

Gilead Sees Room For Trodelvy In European Markets

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.

Market Access Business Strategies

Pipeline Watch: Phase III Readouts in Fabry's Disease And COVID-19

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.

Pipeline Watch Approvals

Keytruda Cements Cervical Cancer Leadership With First-Line Nod

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.

Approvals ImmunoOncology

Lilly’s Early Bird Verzenio Goes After Up To S4bn Worm With Early Breast Cancer Nod

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.

Approvals Business Strategies

Pipeline Watch: Phase III Trial Starts And COVID-19 Readouts

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.

Pipeline Watch Approvals

ChemoCentryx Gains Runway To Grow With Avacopan Approval

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.

Approvals Commercial

Biohaven’s Q3 Nurtec ODT Sales Indicate Gains Across Multiple Launch Parameters

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.

Launches Sales & Earnings
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