Blog
RSS FeedPosted by Michael Wonder on 01 Dec 2020
Mirum Pharmaceuticals announces European Medicines Agency validation of the marketing authorisation application for maralixibat in patients with PFIC2
30 November 2020 - Five-year transplant-free survival data from the Phase 2 INDIGO study used as the basis for the MAA ...
Posted by Michael Wonder on 01 Dec 2020
ARS announces acceptance of market authorisation application submission to European Medicines Agency for Neffy (ARS-1; epinephrine nasal spray)
30 November 2020 - ARS Pharmaceuticals announced today that the EMA has accepted a marketing authorisation application submission for review of ...
Posted by Michael Wonder on 30 Nov 2020
Dupixent (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis
30 November 2020 - Pivotal trial showed more than four times as many children achieved itch reduction and more than three ...
Posted by Michael Wonder on 28 Nov 2020
Vertex announces European Commission approval for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 6-11 years
27 November 2020 - The combination therapy is a new treatment option for CF patients who are homozygous for F508del. ...
Posted by Michael Wonder on 27 Nov 2020
Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
27 November 2020 - EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities that urges all stakeholders, ...
Posted by Michael Wonder on 26 Nov 2020
European Medicines Agency validates application for tepotinib for the treatment of advanced NSCLC with METex14 skipping alterations
26 November 2020 - Merck today announced that the EMA has validated for review, the application for tepotinib for the ...
Posted by Michael Wonder on 26 Nov 2020
Moderna signs deal with EU for 160 million COVID-19 vaccine doses
26 November 2020 - The European Commission has signed a supply deal with Moderna which will see it secure an ...
Posted by Michael Wonder on 26 Nov 2020
European Commission approves Janssen’s Tremfya (guselkumab), a first-in-class treatment for active psoriatic arthritis
25 November 2020 - Guselkumab is the first selective IL-23 p19 subunit inhibitor licensed for both the treatment of psoriatic arthritis ...
Posted by Michael Wonder on 26 Nov 2020
Bio-Thera Solutions submits marketing authorisation application for BAT1706, a proposed biosimilar to Avastin, to European Medicines Agency
25 November 2020 - Bio-Thera Solutions today announced that it has submitted the marketing authorisation application for BAT1706, a proposed biosimilar ...
Posted by Michael Wonder on 25 Nov 2020
EU drug regulator could rule on COVID-19 vaccines by year end
24 November 2020 - The EMA could produce a scientific opinion on COVID-19 vaccines seeking regulatory approval by the end ...
Posted by Michael Wonder on 25 Nov 2020
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) as second-line treatment for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
24 November 2020 - First immunotherapy to be approved for a gastro-esophageal cancer in the European Union. ...
Posted by Michael Wonder on 24 Nov 2020
ObsEva submits marketing authorisation application to the European Medicines Agency for Yselty (linzagolix) for the treatment of women with uterine fibroids
24 November 2020 - If approved, linzagolix will be the only GnRH antagonist with flexible dose regimen options for the management ...
Posted by Michael Wonder on 24 Nov 2020
Merck submits applications for licensure of V114, the company’s investigational 15 valent pneumococcal conjugate vaccine, for use in adults to the US FDA and EMA
23 November 2020 - Merck today announced the company has submitted applications to the US FDA and EMA for licensure of ...
Posted by Michael Wonder on 24 Nov 2020
VBI Vaccines announces submission of marketing authorisation application for 3 antigen prophylactic hepatitis B vaccine to the European Medicines Agency
23 November 2020 -VBI Vaccines today announced the submission of a marketing authorisation application to the EMA for the Company’s ...
Posted by Michael Wonder on 23 Nov 2020
Workshop on regulatory support for development of orphan medicines
23 November 2020 - On Monday, 30 November, EMA is hosting a workshop to discuss the benefits and impact of ...