Blog
RSS FeedPosted by Michael Wonder on 08 Dec 2020
NICE backs AstraZeneca's Calquence for chronic lymphocytic leukaemia
8 December 2020 - NICE has published preliminary guidelines backing use of AstraZeneca's Calquence (acalabrutinib) as an NHS funded treatment ...
Posted by Michael Wonder on 08 Dec 2020
CDER focuses on novel drug development tools to help speed creation of new therapies
7 December 2020 - There are many novel drug development tools that incorporate the latest advances in science and technology but ...
Posted by Michael Wonder on 08 Dec 2020
Statement on litigation challenging legality of the Administration’s most favoured nation rule
4 December 2020 - Today, the Pharmaceutical Research and Manufacturers of America, the Association of Community Cancer Centers, the Global Colon ...
Posted by Michael Wonder on 07 Dec 2020
EMA publishes agenda for 7-10 December CHMP meeting
7 December 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 07 Dec 2020
SMC - December 2020 decisions
7 December 2020 - Medicines which can be used to treat a form of blood cancer and a rare muscle ...
Posted by Michael Wonder on 07 Dec 2020
Immunicum receives FDA fast track designation for ilixadencel in gastro-intestinal stromal tumours
7 December 2020 - Immunicum announced today that it has received fast track designation from the U.S. FDA for the Company’s ...
Posted by Michael Wonder on 07 Dec 2020
Scynexis announces FDA acceptance and priority review of new drug application for oral ibrexafungerp for the treatment of vaginal yeast infections
7 December 2020 - 6 month Priority Review granted for ibrexafungerp with PDUFA target action date set for 1 June 2021. ...
Posted by Michael Wonder on 07 Dec 2020
Chimerix announces FDA acceptance of new drug application for brincidofovir as a medical countermeasure for smallpox
7 December 2020 - Chimerix today announced that the U.S. FDA has accepted the filing of a new drug application ...
Posted by Michael Wonder on 07 Dec 2020
scPharmaceuticals receives complete response letter from FDA for Furoscix
7 December 2020 - Complete response letter did not identify clinical deficiencies. ...
Posted by Michael Wonder on 07 Dec 2020
Janssen seeks EU approval for twice yearly schizophrenia treatment
7 December 2020 - Janssen has submitted a marketing authorisation extension application to the EMA for paliperidone palmitate six monthly ...
Posted by Michael Wonder on 07 Dec 2020
Health economic assessment of Beovu in wet age-related macular degeneration
4 December 2020 - TLV has produced a health economic assessment for the regions for Beovu (brolucizumab). ...
Posted by Michael Wonder on 07 Dec 2020
PHARMAC diabetes drugs delay 'bewildering', 'worse than disappointing' - doctors
7 December 2020 - A decision by PHARMAC to defer the approval of two new drugs for the treatment of diabetes ...
Posted by Michael Wonder on 07 Dec 2020
Jacinda Ardern defends Labour's 'perfectly reasonable' decision to veto MP led PHARMAC inquiry
7 December 2020 - Prime Minister Jacinda Ardern is defending Labour's "perfectly reasonable" decision to veto a PHARMAC inquiry led ...
Posted by Michael Wonder on 07 Dec 2020
Update on funding decision for two new diabetes medicines
7 December 2020 - PHARMAC would like to thank everyone who has provided feedback to date on a proposal to ...
Posted by Michael Wonder on 06 Dec 2020
BIO to file lawsuit today to block Trump international drug pricing policy
4 December 2020 - The Biotechnology Innovation Organization will file a lawsuit today to block implementation of President Trump’s new ...