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BioNTech to develop and supply mRNA malaria vaccine
Collaborating with global partners BioNTech will work to develop a safe and effective malaria vaccine and set up its sustainable supply for the African continent.
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The European Commission (EC)
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EU approves Opdivo plus Yervoy for colorectal cancer
The European Commission approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for certain metastatic colorectal cancers after a trial found the combination meaningfully improved response rates.
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US grants new patent targeting major neurodegenerative diseases
Alterity Therapeutics have been granted a patent for compounds able to redistribute excess iron in the brain being developed as a treatment for neurodegenerative diseases including Alzheimer's and Parkinson's.
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Collaboration working to promote health research, development and innovation
A strategic European health research and innovation agenda is being compiled by five industry associations and the European Commission.
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Supply of biosimilars and generics with Adrian van den Hoven, Medicines for Europe
In this interview, Adrian van den Hoven, Director General of Medicines for Europe, discusses all things supply of generic and biosimilar medicines for the continent. Also, in a bonus video, Adrian discusses challenges disrupting access to biosimilars and generics in Europe.
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In silico trial successfully replicates human clinical research results
An in silico trial evaluating a flow diverter in the treatment of brain aneurysms simulated the results of three human clinical trials.
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UK and Europe approve Adtralza for treating atopic dermatitis
EU and UK regulators have approved Adtralza (tralokinumab), a monoclonal antibody, for treating moderate-to-severe atopic dermatitis in adult patients.
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Waiving COVID-19 vaccine intellectual property rights
South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
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Europe approves Ponvory (ponesimod) for multiple sclerosis
The European Commission has approved once daily oral Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis in adult patients.
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EU secures up to 1.8 billion additional doses of Comirnaty® COVID-19 vaccine
Pfizer and BioNTech have agreed to supply Europe with 900 million additional doses of Comirnaty® with the option to request 900 million more in future.
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EC approves Xtandi™ for third prostate cancer indication
Xtandi™ (enzalutamide) was approved for metastatic hormone-sensitive prostate cancer after it reduced the risk of radiographic progression or death by 61 percent in a trial.
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EC approves Cabometyx® and Opdivo® combination for advanced renal cell carcinoma
The combination was approved on Phase III trial results which show it doubled progression-free survival and reduced risk of death by 40 percent, compared to standard of care.
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Evrysdi™ approved for treatment of spinal muscular atrophy in Europe
The European Commission has granted marketing authorisation to Roche’s Evrysdi™ (risdiplam) as a treatment for spinal muscular atrophy in infants, children and adults.
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Pemazyre® approved for adult patients with cholangiocarcinoma in Europe
The approval of Pemazyre® (pemigatinib) was based on Phase II trial results in which the treatment met its primary endpoint, demonstrating a 37 percent overall response rate.
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Janssen COVID-19 Vaccine authorised for use in EU
After a positive recommendation from the EMA, the European Commission has granted the single-dose vaccine conditional marketing authorisation.
