Blog
RSS FeedPosted by Michael Wonder on 08 Sep 2022
Esketamine: NICE’s appraisal was unfair, appeal panel rules
8 September 2022 - The decision by the UK National Institute for Health and Care Excellence not to recommend esketamine ...
Posted by Michael Wonder on 08 Sep 2022
British Colombia expands children’s access to ‘transformational’ cystic fibrosis drug
7 September 2022 - A week after a B.C. family went public with its plea for a life-changing drug for ...
Posted by Michael Wonder on 08 Sep 2022
MHRA approves olaparib for high-risk, early stage breast cancer
7 September 2022 - The Institute of Cancer Research, London, celebrates the news that the precision medicine olaparib has been ...
Posted by Michael Wonder on 08 Sep 2022
Revance announces FDA approval of Daxxify (daxibotulinumtoxinA-lanm) for injection, the first and only peptide formulated neuromodulator with long-lasting results
8 September 2022 - Based on the data from SAKURA, Daxxify has the ability to deliver year long results with as ...
Posted by Michael Wonder on 08 Sep 2022
Health Canada approves Pluvicto as first targeted radioligand therapy for progressive PSMA positive metastatic castration-resistant prostate cancer
7 September 2022 - Novel mechanism of action of Pluvicto binds to target PSMA positive cancer cells, delivering radiation treatment directly ...
Posted by Michael Wonder on 08 Sep 2022
Pharmac issues RFP for intravenous trastuzumab, a medicine used to treat breast cancer
8 September 2022 - PHARMAC is seeking commercial bids from pharmaceutical suppliers for the supply of intravenous trastuzumab, a ‘biologic’ ...
Posted by Michael Wonder on 07 Sep 2022
FDA accepts Integral Molecular's letter of intent on membrane proteome array antibody specificity test into ISTAND drug development tools pilot program
7 September 2022 - Integral Molecular has been accepted into the US FDA's ISTAND pilot program. ...
Posted by Michael Wonder on 07 Sep 2022
Ongoing uncertainty about prices will deter new drug launches in Canada
7 September 2022 - Further delays in access or complete denials of access to innovative drugs will hurt even more Canadians ...
Posted by Michael Wonder on 07 Sep 2022
AmMax Bio announces AMB-05X granted FDA fast track designation for the treatment of tenosynovial giant cell tumour
7 September 2022 - Proof of concept established in Phase 2 Trial of TGCT, with positive efficacy results across multiple clinical ...
Posted by Michael Wonder on 07 Sep 2022
CDER and CBER accept first submission to ISTAND pilot program
7 September 2022 - The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research have ...
Posted by Michael Wonder on 07 Sep 2022
The FDA needs to be more flexible in assessing treatments for rare diseases, like the one that seemed to help my son
7 September 2022 - Every time I read about clinical trials testing possible treatments for rare diseases, I think of ...
Posted by Michael Wonder on 07 Sep 2022
Seres Therapeutics announces completion of rolling BLA submission to FDA for investigational microbiome therapeutic SER-109 for recurrent C. difficile infection
7 September 2022 - Investigational therapeutic SER-109 has the potential to become the first-ever FDA approved oral microbiome therapeutic. ...
Posted by Michael Wonder on 07 Sep 2022
Tarsus submits new drug application to the FDA for TP-03 for the treatment of demodex blepharitis
7 September 2022 - Tarsus Pharmaceuticals today announced that it has submitted a new drug application to the US FDA for ...
Posted by Michael Wonder on 07 Sep 2022
Rhythm Pharmaceuticals announces Imcivree (setmelanotide) granted marketing authorisation by European Commission for treatment of obesity and control of hunger in Bardet-Biedl syndrome
6 September 2022 - Setmelanotide now FDA approved and EC authorized for Bardet-Biedl syndrome. ...
Posted by Michael Wonder on 07 Sep 2022
QOL Medical receives FDA approval of Sucraid (sacrosidase) oral solution single-use containers for patients with congenital sucrase-isomaltase deficiency
6 September 2022 - QOL Medical announced today that the US FDA approved Sucraid single-use containers for patients more than 33 ...