The European Commission has granted Orphan Drug Designation for Vivet Therapeutics’ gene therapy product VTX-806 for the treatment of Cerebrotendinous Xanthomatosis (CTX).
Janssen, a Johnson & Johnson company, has announced that its bispecific antibody has been granted approval by the European Commission (EC) for use in certain patients with relapsed or refractory multiple myeloma (RRMM).
Servier has received marketing approval from the European Commission (EC) for Tibsovo (ivosidenib tablets) to treat isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukaemia (AML) and IDH1-mutated cholangiocarcinoma.
A judgement has been issued in the legal dispute between the European Commission and AstraZeneca over a shortfall of delivery of the company’s COVID-19 vaccine doses to the EU-27.
The EU Commission has published a redacted version of the contract it signed with AstraZeneca on COVID-19 vaccine delivery in August last year, in a bid to show that the pharma giant is backtracking on its commitments.
Biopharma company, CureVac, and Wacker Chemie have signed a contract for the manufacturing of CureVac’s mRNA-based COVID-19 vaccine candidate - CVnCoV.
Regeneron and Sanofi’s Libtayo is granted marketing authorization by the European Commission for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.
Pfizer says it remains committed to Inflectra and partner Celltrion after gaining US FDA approval for another infliximab biosimilar, Ixifi, developed in-house.
Mvasi has been recommended for approval in Europe, but a duplicate marketing authorisation application for an Avastin (bevacizumab) biosimilar has been withdrawn by Amgen.
Separate GMP rules for advanced therapies would put patients at risk according to the PIC/S, which has called on the European Commission (EC) to rethink the idea.
European biopharmas trying to avoid “death valley” went to California this week according to industry groups, investors and officials who met in Belgium this week to discuss ways of making it easier for companies to access funding on this side of the...
CureVac has been awarded a grant by the European Commission (EC), which says the firm's room temperature-stable mRNA-based vaccines could overcome one of the biggest barriers to disease prevention in developing countries.
Stada Arzneimittel has licensed European rights to a biosimilar version of the white blood cell booster filgrastim from Apotex and says it is not worried by competitors already in the market.
The European Commission continues to be accused by European
industry of pushing 'green policies' that are stifling progress and
global competitiveness - the controversial REACH chemicals
legislation remains a sore point.
