Blog
RSS FeedPosted by Michael Wonder on 17 Nov 2019
CHMP recommends EU approval of Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neo-adjuvant treatment
15 November 2019 - Kadcyla cut the risk of disease recurrence or death by half compared to Herceptin in the adjuvant ...
Posted by Michael Wonder on 17 Nov 2019
CHMP recommends conditional EU approval of Roche’s Polivy for people with previously treated aggressive lymphoma
15 November 2019 - First-in-class antibody-drug conjugate that specifically targets CD79b, a protein expressed in the majority of B-cells. ...
Posted by Michael Wonder on 16 Nov 2019
Novartis receives positive CHMP opinion for Mayzent (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis
15 November 2019 - If approved, Mayzent (siponimod) will be the first and only oral treatment specifically indicated for patients ...
Posted by Michael Wonder on 15 Nov 2019
Highlights from the CHMP 11-14 November 2019 meeting
15 November 2019 - Seven new medicines recommended for approval. ...
Posted by Michael Wonder on 15 Nov 2019
Dutch authorities hand over final building to EMA in Amsterdam
15 November 2019 - Today, the Dutch authorities have handed over to EMA its newly built tailor-made premises, located in ...
Posted by Michael Wonder on 13 Nov 2019
Regulators’ advice can make a difference for faster patient access to highly innovative therapies
12 November 2019 - Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies and patients can play ...
Posted by Michael Wonder on 13 Nov 2019
Actelion withdraws regulatory filings to extend the indication of Opsumit (macitentan 10mg) in CTEPH
12 November 2019 - Actelion Pharmaceuticals has announced its decision to voluntarily withdraw the European and other health authority filings ...
Posted by Michael Wonder on 12 Nov 2019
EMA publishes agenda for 11-14 November CHMP meeting
11 November 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 12 Nov 2019
Merck’s Ervebo [Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP) live] granted conditional approval in the European Union
12 November 2019 - Authorisation represents significant advancement in the global response to Ebola. ...
Posted by Michael Wonder on 11 Nov 2019
‘Regulatory science to 2025’: live broadcast of post-consultation workshop
11 November 2019 - The European Medicines Agency is hosting a multi-stakeholder workshop on the human medicine aspects of its ...
Posted by Michael Wonder on 09 Nov 2019
Johnson & Johnson announces submission of European marketing authorisation applications for Janssen’s investigational Ebola vaccine regimen
7 November 2019 - Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated ...
Posted by Michael Wonder on 07 Nov 2019
EMA validates Bratovi, Mektovi application for some mCRC
7 November 2019 - The EMA has validated Pierre Fabre’s application for a Braftovi (encorafenib) and Mektovi (binimetinib) combination for ...
Posted by Michael Wonder on 06 Nov 2019
One shot drug to end Sicilian curse comes at $1.8 million cost
5 November 2019 - A new targeted gene therapy shows the promise and pitfalls of medical advances. ...
Posted by Michael Wonder on 06 Nov 2019
Octapharma’s fibryga receives European label extension to treat acquired fibrinogen deficiency (AFD)
5 November 2019 - Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of ...
Posted by Michael Wonder on 01 Nov 2019
Vertex announces EMA marketing authorisation application validation for VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination treatment in cystic fibrosis
31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages ...