Blog
RSS FeedPosted by Michael Wonder on 11 Mar 2022
ATAGI update following weekly COVID-19 meeting (9 March 2022)
11 March 2022 - ATAGI have not made any new updates since 2 March 2022. ...
Posted by Michael Wonder on 11 Mar 2022
Allogene Therapeutics receives FDA fast track designation for its first solid tumour candidate, ALLO-316 in the treatment of renal cell carcinoma
10 March 2022 - ALLO-316 is an allogeneic CAR T therapy candidate targeting CD70, which has broad potential application across a ...
Posted by Michael Wonder on 11 Mar 2022
Janssen seeks approval of a new indication for Imbruvica (ibrutinib) for use in patients with untreated mantle cell lymphoma
8 March 2022 - Application based on Phase 3 SHINE study results, which investigated the safety and efficacy of all-oral ...
Posted by Michael Wonder on 10 Mar 2022
Health Canada approves Samsung Bioepis and Biogen’s Byooviz (SB11), Lucentis biosimilar (ranibizumab)
10 March 2022 - Byooviz becomes the first Lucentis biosimilar to be approved in Canada following its approval in Europe and ...
Posted by Michael Wonder on 10 Mar 2022
Servier submits a marketing authorisation application to the EMA for Tibsovo (ivosidenib) for patients with IDH1 mutated acute myeloid leukaemia and cholangiocarcinoma
10 March 2022 - The submission covers countries of the European Union as well as Iceland, Liechtenstein and Norway. ...
Posted by Michael Wonder on 10 Mar 2022
Revance resubmits biologics license application for daxibotulinumtoxinA for injection for glabellar lines to the FDA
8 March 2022 - Revance Therapeutics today announced it has resubmitted its biologics license application to the U.S. FDA for DaxibotulinumtoxinA ...
Posted by Michael Wonder on 10 Mar 2022
Legislation would set expiration for FDA’s accelerated approvals
9 March 2022 - New legislation, introduced by a top Democrat in the House of Representatives, would codify the U.S. ...
Posted by Michael Wonder on 10 Mar 2022
When desperate patients go to court for unproven treatments - the battle for hospital independence
9 March 2022 - During the COVID-19 pandemic, patients have asked courts to compel hospitals to administer unproven therapies, including ivermectin. ...
Posted by Michael Wonder on 10 Mar 2022
COVID-19 vaccine weekly safety report (10 March 2022)
10 March 2022 - To 6 March 2022, the TGA has received 460 reports which have been assessed as likely ...
Posted by Michael Wonder on 09 Mar 2022
TGA approves provisional determination for Biocelect for COVID-19 vaccine Nuvaxovid
10 March 2022 - The TGA has granted a second provisional determination to Biocelect (on behalf of Novavax) in relation ...
Posted by Michael Wonder on 09 Mar 2022
Insightec receives FDA IDE approval and breakthrough designation for NSCLC brain mets study
9 March 2022 - Designation and approvals mark key milestones in advancing Insightec blood brain barrier clinical roadmap using acoustic ...
Posted by Michael Wonder on 09 Mar 2022
Bayer submits applications in the U.S. and EU for additional indication of Nubeqa (darolutamide)
9 March 2022 - Submissions are based on data from the pivotal Phase 3 ARASENS trial recently published in The New ...
Posted by Michael Wonder on 09 Mar 2022
More Government regulation of biopharma would harm patients and the economy
8 March 2022 - The United States leads the world in creating the new drugs and vaccines that cure or control ...
Posted by Michael Wonder on 09 Mar 2022
7 Hills Pharma’s clinical stage novel immunostimulant 7HP349 granted FDA fast track designation for anti-PD-1 resistant metastatic melanoma
8 March 2022 - 7 Hills Pharma announced today that the U.S. FDA has granted fast track designation to 7HP349, 7HP’s ...
Posted by Michael Wonder on 08 Mar 2022
Vaccine approval before Phase 3 trial results: a consequence of vaccine access inequity
2 March 2022 - The final Phase 3 clinical data for CanSino Biologics' adenovirus type 5 vector vaccine show that Ad5-nCoV ...