# European Medicines Agency (EMA)

Type: Company

Source: GetYourBrief — https://getyourbrief.com/entity/european-medicines-agency-ema-company
Canonical HTML page: https://getyourbrief.com/entity/european-medicines-agency-ema-company

## Timeline

- **2026-07-28**: High Court grants permission for judicial review — Judge Cian Ferriter allows Emily Felix's challenge against the HSE and Minister for Health to proceed, citing arguable grounds regarding the delay.
- **2026-07-28**: High Court grants permission for judicial review — Judge Cian Ferriter allows Emily Felix's challenge against the HSE and Minister for Health to proceed, citing arguable grounds regarding the delay.
- **2025-12**: NCPE pharmacoeconomic evaluation completed — The National Centre for Pharmacoeconomics delivers its assessment of Skyclarys' cost-effectiveness to the HSE.
- **2025-12**: NCPE pharmacoeconomic evaluation completed — The National Centre for Pharmacoeconomics delivers its assessment of Skyclarys' cost-effectiveness to the HSE.
- **2024-08**: HSE reimbursement application filed — Biogen submits a formal pricing and reimbursement application to the HSE to add Skyclarys to the public drug list.
- **2024-08**: HSE reimbursement application filed — Biogen submits a formal pricing and reimbursement application to the HSE to add Skyclarys to the public drug list.
- **2024-02**: European market authorisation — The European Commission grants centralised marketing authorisation for Biogen's Skyclarys (omaveloxolone) for patients over 16.
- **2024-02**: European market authorisation — The European Commission grants centralised marketing authorisation for Biogen's Skyclarys (omaveloxolone) for patients over 16.
- **2010**: Diagnosis with Friedreich's ataxia — Emily Felix, then 12 years old, is diagnosed with the rare, progressive neuromuscular disease.
- **2010**: Diagnosis with Friedreich's ataxia — Emily Felix, then 12 years old, is diagnosed with the rare, progressive neuromuscular disease.

## Recent coverage (6 stories, network-wide)

### Biogen’s Skyclarys Faces Irish Access Battle as 12 EU Nations Already Fund It
2026-08-03 15:05:46 · Sector: bio · Sentiment: Neutral · Impact: 5/10 · Sources: 2

Biogen’s orphan drug for Friedreich’s ataxia, approved by the EMA since February 2024, remains mired in Irish reimbursement ambiguity, prompting a patient’s judicial review and highlighting the EU’s fragmented market access for novel therapies.
Full story: https://getbiobrief.com/story/biogen-skyclarys-irish-access-battle-12-eu

### Patient Sues HSE After 23-Month Delay on Drug Available in 12 EU States
2026-08-03 15:05:07 · Sector: legal · Sentiment: Neutral · Impact: 5/10 · Sources: 2

Emily Felix, 28, launches judicial review against the HSE for failing to decide on funding for Biogen's Friedreich's ataxia drug for nearly two years, despite EMA approval and availability across a dozen EU nations.
Full story: https://getlegalbrief.com/story/patient-sues-hse-23-month-delay-drug-12-eu

### Rare Disease Patient ‘Fighting for Survival’ as HSE Stalls Drug Access 23 Months
2026-08-03 15:04:56 · Sector: health · Sentiment: Neutral · Impact: 5/10 · Sources: 2

A woman with Friedreich’s ataxia sues the HSE over an unacceptably prolonged reimbursement decision for omaveloxolone, a treatment that could slow her decline and that is already standard care in 12 other European countries.
Full story: https://gethealthbrief.com/story/rare-disease-patient-fighting-survival-hse-delay

### 4th EMA GMP Win Clears 19 Biologics for EU Patients
2026-06-18 07:09:49 · Sector: health · Sentiment: Positive · Impact: 7/10 · Sources: 2

WuXi Biologics' Suzhou facility earned its fourth EMA GMP certificate with zero findings, paving the way for 19 biologic therapies to reach European patients. This achievement reinforces the critical role of rigorous biosafety testing in safeguarding the global healthcare supply chain.
Full story: https://gethealthbrief.com/story/wuxi-biologics-4th-ema-gmp-19-biologics-healthcare

### WuXi Bio's 4th EMA GMP Quiver: 19 Products, 13 Clients Strong
2026-06-18 07:09:43 · Sector: bio · Sentiment: Positive · Impact: 7/10 · Sources: 2

With zero critical findings on its fourth EMA GMP certification, WuXi Biologics now empowers 13 biotech clients to commercialize 19 biologics in Europe. This milestone validates the company's integrated CRDMO model and deepens its competitive moat in the biologics CDMO space.
Full story: https://getbiobrief.com/story/wuxi-bio-4th-ema-gmp-13-clients-biotech

### Chikungunya Transmission Risk Expands Across Europe Amid Climate Shift
2026-02-19 12:54:45 · Sector: bio · Sentiment: Negative · Impact: 7/10 · Sources: 2

A landmark study reveals that the excruciating tropical disease Chikungunya is now capable of local transmission across most of Europe. Driven by the northward migration of the Aedes albopictus mosquito, this shift creates an urgent demand for vaccines and diagnostic infrastructure in previously unaffected regions.
Full story: https://getbiobrief.com/story/chikungunya-transmission-risk-europe-pharma-impact

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