Blog
RSS FeedPosted by Michael Wonder on 25 Apr 2022
Tremelimumab accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi
25 April 2022 - STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual ...
Posted by Michael Wonder on 25 Apr 2022
Swissmedic grants conditional marketing authorisation for Novavax COVID-19 vaccine
13 April 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine authorised for use in Switzerland. ...
Posted by Michael Wonder on 24 Apr 2022
Update on regulatory submission for aducanumab in the European Union
22 April 2022 - Biogen has notified the EMA of its decision to withdraw its marketing authorisation application for aducanumab for ...
Posted by Michael Wonder on 24 Apr 2022
CHMP recommends EU approval of Roche’s Tecentriq as adjuvant treatment for a subset of people with early-stage non-small-cell lung cancer
22 April 2022 - In the Phase III IMpower010 trial, adjuvant Tecentriq reduced the risk of disease recurrence or death by ...
Posted by Michael Wonder on 24 Apr 2022
CHMP adopts positive opinion for Filsuvez for the treatment of dystrophic and junctional EB
22 April 2022 - Positive opinion based on largest ever pivotal global Phase 3 EASE trial undertaken in epidermolysis bullosa. ...
Posted by Michael Wonder on 24 Apr 2022
Novartis receives positive CHMP opinion for Tabrecta for patients with METex14 advanced non-small-cell lung cancer
22 April 2022 - Opinion based on Phase 2 GEOMETRY mono-1 study showing an overall response rate (ORR) of 51.6% ...
Posted by Michael Wonder on 23 Apr 2022
CHMP recommends EU conditional approval of Roche’s potential first in class bispecific antibody mosunetuzumab for people with relapsed or refractory follicular lymphoma
22 April 2022 - The recommendation is based on the GO29781 study where mosunetuzumab induced high complete response rates, with ...
Posted by Michael Wonder on 23 Apr 2022
Highlights from the 19-22 April 2022 CHMP meeting
22 April 2022 - The EMA’s CHMP recommended four medicines for approval in the European Union at its April 2022 ...
Posted by Michael Wonder on 23 Apr 2022
Medexus Pharmaceuticals announces resubmission of treosulfan NDA
22 April 2022 - Additional data collection and analysis reconfirms confidence in new drug application for treosulfan. ...
Posted by Michael Wonder on 23 Apr 2022
Quanterix granted breakthrough device designation from U.S. FDA for NfL test for multiple sclerosis
22 April 2022 - Blood based assay has the potential to serve the multiple sclerosis community in management of relapsing-remitting form ...
Posted by Michael Wonder on 21 Apr 2022
Bridge to Life receives breakthrough device designation from the FDA
21 April 2022 - Bridge to Life advances their perfusion system development with the breakthrough device designation for the LifeCradle ...
Posted by Michael Wonder on 21 Apr 2022
Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?
21 April 2022 - On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of what ...
Posted by Michael Wonder on 21 Apr 2022
What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.
21 April 2022 - The word breakthrough carries a kind of weight: it’s a dramatic step forward, a critical advance in ...
Posted by Michael Wonder on 21 Apr 2022
Revance receives FDA acceptance of BLA resubmission for daxibotulinumtoxinA for injection for glabellar lines
21 April 2022 - PDUFA goal date set for 8 September 2022. ...
Posted by Michael Wonder on 21 Apr 2022
Zambon receives U.S. FDA breakthrough therapy designation for CMS I-neb in patients with non-cystic fibrosis bronchiectasis
21 April 2022 - CMS I-neb is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients ...