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
FDA approves first targeted therapy to treat patients with painful complication of sickle cell disease
15 November 2019 - Today, the U.S. FDA approved Adakveo (crizanlizumab-tmca), a treatment to reduce the frequency of vaso-occlusive crisis – ...
Posted by Michael Wonder on 14 Nov 2019
FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance
14 November 2019 - The U.S. FDA today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of ...
Posted by Michael Wonder on 14 Nov 2019
FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumour shrinkage
14 November 2019 - Today, the U.S. FDA granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients ...
Posted by Michael Wonder on 14 Nov 2019
NICE ‘OK’ for Sativex in MS
14 November 2019 - NICE has recommended Bayer’s Sativex (delta-9 tetrahydrocannabinol cannabidiol), for spasticity in people with multiple sclerosis. ...
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
NICE recommends Elmiron for bladder pain syndrome
13 November 2019 - NICE has recommended Consilient Health’s Elmiron (pentosan polysulfate sodium) for bladder pain syndrome. ...
Posted by Michael Wonder on 13 Nov 2019
NICE during the pre-election period
12 November 2019 - As a public body, NICE is required to follow civil service principles on communicating during the lead ...
Posted by Michael Wonder on 13 Nov 2019
Exelixis’ partner Ipsen announces Health Canada’s approval of Cabometyx (cabozantinib) tablets for the treatment of patients with previously treated advanced hepatocellular carcinoma
12 November 2019 - Approval based on statistically significant and clinically meaningful overall survival benefit demonstrated in the CELESTIAL phase 3 ...
Posted by Michael Wonder on 13 Nov 2019
Drug Utilisation Sub-Committee outcome statement
13 November 2019 - The outcome statement from the October 2019 Drug Utilisation Sub-Committee meeting is now available. ...
Posted by Michael Wonder on 12 Nov 2019
Health economic assessment of Tecentriq for triple negative breast cancer
8 November 2019 - TLV has produced a health economic knowledge base for the county council for the drug Tecentriq (atezolizumab). ...
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. ...