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RSS FeedPosted by Michael Wonder on 07 Nov 2020
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer
6 November 2020 - Approval based on Phase 3 CheckMate-9LA trial results showing superior overall survival in patients with metastatic non-small ...
Posted by Michael Wonder on 06 Nov 2020
International regulators and WHO join forces to address COVID-19 challenges
6 November 2020 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have committed to working together ...
Posted by Michael Wonder on 06 Nov 2020
Brilinta approved in the US to reduce the risk of stroke in patients with an acute ischaemic stroke or high-risk transient ischaemic attack
6 November 2020 - New indication expands use of Brilinta beyond cardiovascular disease to patients with mild-to-moderate stroke ...
Posted by Michael Wonder on 06 Nov 2020
New drug for gastro-intestinal stromal tumours to be launched in Australia, New Zealand and South East Asia following distribution agreement
5 November 2020 - Qinlock is already approved by the TGA and US FDA. ...
Posted 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 ...