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RSS FeedPosted by Michael Wonder on 06 Nov 2020
Clinical Trial Exemption (CTX) scheme renamed as Clinical Trial Approval (CTA) scheme
6 November 2020 - The TGA has changed the name of the Clinical Trial Exemption (CTX) scheme to the Clinical ...
Posted by Michael Wonder on 06 Nov 2020
Genmab announces that Janssen has submitted a Type II variation application to the European Medicines Agency for use of subcutaneous Darzalex (daratumumab) in patients with light-chain amyloidosis
5 November 2020 - Submission is based on data from the Phase 3 ANDROMEDA (AMY3001) trial. ...
Posted by Michael Wonder on 05 Nov 2020
EMA will assess potential COVID-19 vaccine on ‘case by case’ basis
5 November 2020 - Agency will not specify a minimum level of efficacy. ...
Posted by Michael Wonder on 05 Nov 2020
Vertex announces European Commission approval for Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with cystic fibrosis as early as four months of age
5 November 2020 - Approval provides opportunity to treat the underlying cause of cystic fibrosis earlier than ever before in Europe. ...
Posted by Michael Wonder on 05 Nov 2020
Lynparza approved in the EU as first-line maintenance treatment with bevacizumab for HRD positive advanced ovarian cancer
5 November 2020 - Patients treated with Lynparza and bevacizumab lived without disease progression for a median of 37.2 months vs. ...
Posted by Michael Wonder on 05 Nov 2020
Lynparza approved in the EU for the treatment of BRCA mutated metastatic castration-resistant prostate cancer
5 November 2020 - Only PARP inhibitor to improve overall survival versus new hormonal agent treatments in BRCA mutated metastatic ...
Posted by Michael Wonder on 05 Nov 2020
Forxiga approved in the EU for heart failure
5 November 2020 - Forxiga is the first SGLT2 inhibitor approved in the EU for heart failure with reduced ejection ...
Posted by Michael Wonder on 05 Nov 2020
Sobi launch Doptelet (avatrombopag) in Europe
4 November 2020 - Sobi today announced the commercial launch of Doptelet (avatrombopag) in Europe, with the United Kingdom as ...
Posted by Michael Wonder on 04 Nov 2020
LogicBio Therapeutics receives FDA fast track designation for LB-001 for the treatment of methylmalonic acidemia
4 November 2020 - LogicBio Therapeutics announced today the U.S. FDA has granted fast track designation to its clinical candidate, LB-001 ...
Posted by Michael Wonder on 04 Nov 2020
Salvia BioElectronics receives FDA breakthrough device designation for innovative neurostimulation solution
3 November 2020 - Salvia BioElectronics announced today that the U.S, FDA has granted breakthrough device designation for its implantable ...
Posted by Michael Wonder on 04 Nov 2020
Health Canada approves Canada’s first HIV self test
3 November 2020 - For the first time, Canadians will have access to at-home HIV self test kits. bioLytical Laboratories ...
Posted by Michael Wonder on 03 Nov 2020
Regulatory policy may not stop comparative efficacy trials
4 November 2020 - The way Sarfaraz K. Niazi, looks at it, doing comparative efficacy studies in humans to confirm that ...
Posted by Michael Wonder on 03 Nov 2020
GenSight Biologics reports validation of Lumevoq marketing authorisation application by European Medicines Agency
3 November 2020 - GenSight Biologics today reported that the Lumevoq marketing authorisation application passed the validation checks required for submissions ...
Posted by Michael Wonder on 03 Nov 2020
ChemoCentryx and VFMCRP announce European Medicines Agency has accepted to review the marketing authorisation application for avacopan
3 November 2020 - Regulatory submission based on positive data from the pivotal Phase 3 ADVOCATE trial of avacopan. ...
Posted by Michael Wonder on 03 Nov 2020
FDA approves updated label for Endari
3 November 2020 - Emmaus Life Sciences announced today revised prescribing information for Endari to better inform healthcare professionals and sickle ...