Monday briefing
Week of 1 Sep 2026
HM
Portfolio launch readiness
11 products in market or inside their launch window. Status rolls up automatically from the five readiness pillars — Market Access & Evidence and Regulatory, Supply & Product block a launch, the other three are advisory.
Product
Country
Showing the whole portfolio
Launches tracked
94
11 products
Every product and country in the programme.
On track
59
63%
All five pillars green. No action needed this week.
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At risk
29
31%
A pillar has gone amber. Launch is not blocked.
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Recommendations to de-risk →
Off track
6
6%
Market Access or Regulatory is red. Launch is blocked until it clears.
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Recommendations to recover →
Revenue at risk
$3.2B
11% of the $29.6B year-one forecast in scope
Blocked $785M
At risk $2.5B
Protected $26.3B
$785M sits behind launches that are blocked outright, and $2.5B behind launches carrying an open amber pillar.
Exposure assumes 60% of year-one revenue is at stake on an off-track launch and 25% on an at-risk launch.
Top 5 contributors
Trenzavu · Brazil
$236M
Off track · launches in 11 days · $393M forecast
Velsoryx · Germany
$176M
Off track · in market 12 days · $293M forecast
Cerastal · Brazil
$125M
At risk · launches in 95 days · $499M forecast
Trenzavu · Canada
$125M
At risk · launches in 26 days · $498M forecast
Decisions needed first
6 launches are blocked by a red Market Access or Regulatory pillar. Each one needs a named decision this week.
Blocking pillars first, then the nearest launch date
Critical
Velsoryx — Germany · Market Access & Evidence
In market 12 days
G-BA / IQWiG issued a negative preliminary recommendation on the submitted dossier. Launch is blocked until this clears.
KV
Katrin Vogel · HTA lead, Velsoryx (product-assigned)
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Next steps
Critical
Trenzavu — Brazil · Regulatory, Supply & Product
Launches in 11 days
The ANVISA filing slipped. No validation letter received. Launch is blocked until this clears.
PF
Paulo Ferreira · Regulatory lead, Trenzavu (product-assigned)
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Next steps
Critical
Zasocitinib — Germany · Market Access & Evidence
Launches in 16 days
G-BA / IQWiG issued a negative preliminary recommendation on the submitted dossier. Launch is blocked until this clears.
SK
Stefan Kohler · HTA lead, Europe
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Next steps
Critical
Takhzyro — Spain · Market Access & Evidence
Launches in 20 days
AEMPS issued a negative preliminary recommendation on the submitted dossier. Launch is blocked until this clears.
SK
Stefan Kohler · HTA lead, Europe
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Next steps
Critical
Qdenga — Italy · Regulatory, Supply & Product
Launches in 28 days
The AIFA filing slipped. No validation letter received. Launch is blocked until this clears.
TV
Tomás Vidal · Regulatory affairs lead, Europe
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Next steps
Products
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