Three months after receiving the US green light, CSL’s candidate Hemgenix has become the first gene therapy to gain EU approval for the treatment of hemophilia B.
Following the adoption of a critical list of COVID-19 vaccines and treatments, European Union member states and pharma companies will communicate to ensure sufficient supply to meet evolving demand.
Biogen has withdrawn its Marketing Authorization Application for Aduhelm (aducanumab) for the treatment of the early stages of Alzheimer’s disease in the EU.
The European Commission has concluded exploratory talks with BioNTech-Pfizer to purchase up to 300 million doses of a potential vaccine against COVID-19.
With US spending on biologics reaching $125.5bn in 2018, a new report looks at the level of savings that could potentially be made and contrasts the US with the European market.
Drug counterfeiting means the EU pharmaceutical industry employs 37,700 fewer people than it otherwise would, according to the European Union Intellectual Property Office (EUIPO).
J&J has expressed its concern over patient safety as Novartis'
subsidiary Sandoz has received the green light from the European
Commission to launch the first epoetin alfa biosimilar on the EU
market.
Doctors and cancer researchers have pleaded with EU politicians to
support a strong REACH chemicals regulation in order to halt an
increase in cancer rates, congenital malformations and asthma.
The pharmaceutical and biotechnology industries in the 'new' EU
countries are rapidly expanding, presenting considerable potential,
although parallel imports remain a challenge.
