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RSS FeedPosted by Michael Wonder on 30 Apr 2021
Ilaris receives Health Canada approval as first of its kind treatment for rare, inflammatory disorder, adult-onset Still's disease
29 April 2021 - The approval of Ilaris (canakinumab) in the treatment of adult-onset Still's disease brings hope for Canadians living ...
Posted by Michael Wonder on 30 Apr 2021
Cerapedics announces FDA breakthrough device designation granted for P-15L bone graft for the treatment of degenerative disc disease
29 April 2021 - P-15L bone graft is currently being studied in the Company's ASPIRE IDE clinical trial. ...
Posted by Michael Wonder on 29 Apr 2021
FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for previously untreated metastatic bladder cancer
28 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 10 to 1 in favour of ...
Posted by Michael Wonder on 29 Apr 2021
Australia accused of delaying campaign to allow generic COVID vaccines
29 April 2021 - Australia is among a group of rich countries accused of standing in the way of some ...
Posted by Michael Wonder on 29 Apr 2021
EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen
29 April 2021 - EMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment ...
Posted by Michael Wonder on 29 Apr 2021
Biogen provides regulatory update on the supplemental biologic license application for subcutaneous administration of Tysabri (natalizumab)
28 April 2021 - Biogen today announced that it has received a complete response letter from the U.S. FDA for ...
Posted by Michael Wonder on 29 Apr 2021
COVID-19 vaccine weekly safety report - 28-04-2021
29 April 2021 - The TGA has been closely monitoring suspected adverse events from the use of COVID-19 vaccines since the ...
Posted by Michael Wonder on 28 Apr 2021
FDA takes action for failure to submit required clinical trial results information to ClinicalTrials.gov
28 April 2021 - Being transparent about the results of completed clinical trials enables important advances in the development of medical ...
Posted by Michael Wonder on 28 Apr 2021
Akari Therapeutics receives FDA fast track designation for nomacopan for the treatment of bullous pemphigoid
28 April 2021 - A multicenter Phase 3 trial of nomacopan for the treatment of moderate and severe bullous pemphigoid has ...
Posted by Michael Wonder on 28 Apr 2021
FDA grants priority review for Nefecon for patients with IgA nephropathy
28 April 2021 - Calliditas Therapeutics today announced that the U.S. FDA has accepted the submission and granted priority review for ...
Posted by Michael Wonder on 28 Apr 2021
Vertex announces European Commission approval for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat cystic fibrosis patients 12 years and older with at least one F508del mutation in the CFTR gene
28 April 2021 - New indication includes people ages 12 years and older who have one copy of the F508del mutation ...
Posted by Michael Wonder on 28 Apr 2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases receive complete response letter for pegunigalsidase alfa from FDA
28 April 2021 - Protalix BioTherapeutics and Chiesi Global Rare Diseases today announced that they received a complete response letter from ...
Posted by Michael Wonder on 28 Apr 2021
Biogen to expand access to its ALS drug, but move may come too late for some patient
27 April 2021 - After weeks of controversy, Biogen has agreed to provide an experimental drug for combating ALS to ...
Posted by Michael Wonder on 28 Apr 2021
EYEMATE system for remote glaucoma management obtains FDA breakthrough device designation
28 April 2021 - - Implandata Ophthalmic Products has announced today that its game-changing EYEMATE system for digitally enabled remote patient ...
Posted by Michael Wonder on 28 Apr 2021
FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for PD-L1 positive, metastatic triple negative breast cancer
27 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 7 to 2 in favour of ...