Blog
RSS FeedPosted by Michael Wonder on 03 Feb 2019
CHMP recommends EU approval of Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors
1 February 2019 - First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis in a prospective intra-patient ...
Posted by Michael Wonder on 03 Feb 2019
CHMP recommends EU approval of Roche’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer
1 February 2019 - Recommendation based on the Phase III IMpower150 study which showed that Tecentriq (atezolizumab) in combination with Avastin ...
Posted by Michael Wonder on 03 Feb 2019
Teva receives positive CHMP opinion for Ajovy (fremanezumab) for the prophylaxis of migraine in adults
1 February 2019 - If approved, Ajovy will be the first and only anti-CGRP treatment with quarterly and monthly dosing ...
Posted by Michael Wonder on 03 Feb 2019
Pfizer receives positive CHMP opinion for Vizimpro (dacomitinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations
2 February 2019 - Pfizer today announced that the CHMP of the EMA has adopted a positive opinion recommending Vizimpro ...
Posted by Michael Wonder on 03 Feb 2019
Highlights from the CHMP 28-31 January 2019 meeting
1 February 2019 - EMA’s CHMP recommended six medicines for approval at its January 2019 meeting. ...
Posted by Michael Wonder on 02 Feb 2019
CTI BioPharma receives results of the CHMP oral explanation for pacritinib in the treatment of myelofibrosis and provides development update
1 February 2019 - CTI BioPharma today announced that the Company will withdraw its European marketing authorisation application for pacritinib ...
Posted by Michael Wonder on 01 Feb 2019
AVEO Oncology announces NDA timing update
31 January 2019 - AVEO Oncology today announced that it has accepted the recommendation of the U.S. FDA not to ...
Posted by Michael Wonder on 01 Feb 2019
Sunovion receives complete response letter from FDA for apomorphine sublingual film (APL-130277)
30 January 2019 - Sunovion Pharmaceuticals announced today that the U.S. FDA issued a complete response letter for the new ...
Posted by Michael Wonder on 31 Jan 2019
FDA expands Lilly's Alimta (pemetrexed) label with combination of Keytruda (pembrolizumab) and platinum chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer
31 January 2019 - New approval based on Phase 3 KEYNOTE-189 results. ...
Posted by Michael Wonder on 31 Jan 2019
Public consultation on key principles for the electronic product information of EU medicines
31 January 2019 - EMA, the Heads of Medicines Agencies and the European Commission are launching today a six-month public ...
Posted by Michael Wonder on 31 Jan 2019
Stemline Therapeutics announces validation of marketing authorisation application by the European Medicines Agency
30 January 2019 - Stemline Therapeutics today announced that the EMA has completed its validation of the marketing authorisation application for ...
Posted by Michael Wonder on 31 Jan 2019
A review of patient reported outcomes labelling for oncology drugs approved by the FDA and the EMA (2012-2016)
31 January 2019 - In recent years, the FDA has granted patient-reported outcome labelling to very few oncology drugs. ...
Posted by Michael Wonder on 31 Jan 2019
Innate Pharma receives FDA fast track designation for IPH4102 in relapsed or refractory Sézary syndrome
29 January 2019 - Fast track designation is based on the evaluation of Phase I results demonstrating strong clinical activity, favourable ...
Posted by Michael Wonder on 31 Jan 2019
Xenon provides key regulatory updates on XEN007 and XEN1101
28 January 2019 - FDA grants rare paediatric disease designation to XEN007 for alternating hemiplegia of childhood. ...
Posted by Michael Wonder on 30 Jan 2019
Statement from FDA Commissioner on 2019 efforts to advance the development of complex generics to improve patient access to medicines
30 January 2019 - As part of the FDA’s efforts to promote drug competition and patient access, we’ve advanced many ...