pharmaceuticalcompanies
Malaria is a life-threatening disease caused by parasites transmitted to humans through the bites of infected female Anopheles mosquitoes. It is preventable and curable, but poverty makes it deadly for those who can’t afford treatment. In Kenya, it continues to leave a trail of loss and grief. According to the World Health Organization (WHO), the country had an estimated 5 million malaria cases and over 12,000 deaths in 2022. Most of those affected are children under 5 and pregnant women. Winnie Akinyi, who lives in western Kenya, recently lost her sister Rosebella who fell ill in December and...
Euronews (English)
A European Commission proposal to tighten conditions in which Advanced Therapy Medicinal Products (ATMPs) may benefit from a special exemption for use in hospitals has divided health stakeholders with concerns about the lack of EU-wide data and calling for guarantees on the specific use conditions. The principle of hospital exemption (HE) was first introduced in the EU regulation for ATMPs - medicines for human use based on genes, tissues or cells, and are mainly used to treat rare diseases - in 2007 to allow some treatments to be used without marketing authorisation under certain specified ci...
Euronews (English)
The impact on Advanced Therapy Medicinal Products (ATMPs) is one of the key emerging flashpoints of European Commission proposals to revise the EU’s pharmaceutical legislation which were tabled in April last year. ATMPs are medicines for human use based on genes, tissues or cells, and are mainly used to treat rare diseases, 80% of which are genetic and can be targeted by these innovative treatments. Although ATMPs have transformed treatment of rare diseases, high production and research costs make them inaccessible for many patients. Of 18 gene therapies authorised for EU use in recent years, ...
Euronews (English)
Pharmaceutical giant AstraZeneca reported its first quarter 2024 earnings on Thursday, seeing extremely robust earnings per share (EPS) and revenue growth. This was mainly due to continuously growing partner drug sales, as well as increasing demand for the company’s best-selling medicines. Total revenue soared 19% to $12,679 million (€11,818.1 million) year-on-year, primarily boosted by an 18% growth in product sales. Total revenue for oncology jumped 26%, with respiratory and immunology revenue rising 17% and cardiovascular, renal and metabolism revenue inching up 23%. Rare disease revenue ad...
Euronews (English)
The EU has faced recent shortages of various critical drugs, including paracetamol and some antibiotics, due to a range of supply-chain issues, from low production capacity to shortages in key raw materials combined with a rise in demand across the bloc. During the launch of the Alliance in Brussels (24 April), Health Commissioner Stella Kyriakides said that though shortages are not a new phenomenon, they have been exacerbated by the COVID-19 pandemic and geopolitical challenges. “We have to be able to anticipate possible disruptions for the future, to boost our strategic autonomy and also ens...
Euronews (English)
In April 2023 the European Commission proposed new pharmaceutical legislation updating an existing 20-year-old measure and designed to offer patients equitable access to medicines and to boost the role of the industry across the bloc. The key features of the proposed new rules are the reduction in IP protection periods, the introduction of a new system of incentives aiming to boost EU R&D, and efforts to tackle drug shortages in the bloc. However, hidden in the large number of amendments, members of the Parliament deleted exemptive wording from the original proposal regarding contraceptives an...
Euronews (English)
The EMA has only lately started to look more into the issue of shortages – particularly in public health emergencies or during so-called major events – after an extension of its mandate in 2022 to improve the agency's role in crisis preparedness. National and EU regulators still heavily rely on information they receive from private companies, however, when assessing supply vulnerabilities. “We have to encourage greater transparency because the only way to help mitigate [shortages] is if we understand. And we can only understand if we know,” EMA boss Cooke said. The need to keep information flo...
Euronews (English)
Pharmaceutical giant Novo Nordisk is to take over German biotech company Cardior Pharmaceuticals in a deal worth up to €1.025 billion. The latter, which works mainly on cardiovascular cures, will lay the foundation for Novo Nordisk to expand into the heart disease sector. Novo Nordisk, of weight loss drug Wegovy and diabetes drug Ozempic fame, recently became Europe's biggest company, with a market capitalisation of about DKK 3.05 trillion (€0.41 trillion). The company also accounts for almost 50% of global insulin production. At the time of writing, the company's shares were trading at around...
Euronews (English)
In April 2023 the European Commission proposed new pharmaceutical legislation designed to offer patients equitable access to medicines and to boost the role of the industry across the bloc. As one of the key aspects of the proposal is to make medicines more available, affordable and accessible, the Commission presented new incentives to support innovating companies by increasing regulatory protection of rights over their products. "Learning from the COVID-19 pandemic, this law will make the regulatory framework more efficient by shortening the duration for marketing authorisation and creating ...
Euronews (English)
European lawmakers will seek stronger protection for trade secrets of pharmaceutical companies in talks with EU ministers on new compulsory licensing legislation after a plenary vote on their negotiating mandate held this week. New rules were proposed by the European Commission in April to give the bloc a single instrument for compulsory licensing. Negotiations to approve the final legislative text will start once EU ministers will finalise their own amendments to the commission’s proposal. Governments may grant compulsory licenses in exceptional circumstances allowing use of protected inventi...
Euronews (English)
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