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- PMLiVE

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Biogen receives EC approval for Skyclarys in Friedreich’s ataxia patients

The company gained access to the drug through its $7.3bn acquisition of Reata Pharmaceuticals

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EC approves Vertex/CRISPR’s Casgevy gene therapy for inherited blood disorders

There are now more than 8,000 patients who are potentially eligible for treatment with Casgevy

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Takeda’s HyQvia receives EC approval for rare neuromuscular disorder CIDP

HyQvia can now be used as a maintenance therapy for patients of all ages with CIDP

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GSK’s Omjjara approved by EC to treat myelofibrosis patients with anaemia

About 40% of myelofibrosis patients have moderate-to-severe anaemia at the time of diagnosis

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EC opens participation to new alliance addressing critical drug shortages

The Critical Medicines Alliance is expected to publish its first advice by autumn 2024

- PMLiVE

Roche’s subcutaneous Tecentriq granted EC approval for multiple cancer types

The formulation reduces treatment time by around 80% compared to intravenous infusion

- PMLiVE

Pfizer’s Talzenna combination receives EC approval for metastatic prostate cancer

Approximately 470,000 new cases of prostate cancer were reported in Europe in 2020

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EC approves UCB’s Rystiggo to treat generalised myasthenia gravis

The autoimmune disease has a global prevalence of 100 to 350 cases per every one million people

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EC approves Santhera’s Duchenne muscular dystrophy drug Agamree

The rare muscle-wasting disorder is estimated to affect one in 3,500 male births worldwide

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Merck’s Keytruda approved by EC for two new gastrointestinal cancer indications

Both approvals follow recommendations from the European Medicines Agency’s human medicines committee

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EC, HMA and EMA publish first version of Union list of critical medicines

The established list aims to prevent potential future shortages of critical medicines in the EU

- PMLiVE

Astellas’ menopause drug granted EC approval to treat vasomotor symptoms

More than half of women aged 40 to 64 years experience symptoms such as hot flashes

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