Blog
RSS FeedPosted by Michael Wonder on 23 Sep 2020
UCB achieves important regulatory milestone for bimekizumab
22 September 2020 - The U.S. FDA and EMA have accepted marketing application submissions for bimekizumab for the treatment of adults ...
Posted by Michael Wonder on 23 Sep 2020
Instrumentation Laboratory receives US FDA marketing authorisation for the first apixaban diagnostic test
22 September 2020 - The first direct oral anticoagulant test authorised for clinical use on automated hemostasis systems. ...
Posted by Michael Wonder on 23 Sep 2020
Liminal BioSciences provides update on progress on BLA for Ryplazim (plasminogen)
21 September 2020 - FDA assigns PDUFA target action date of 5 March 2021. ...
Posted by Michael Wonder on 22 Sep 2020
CHMP recommends approval of MenQuadfi for active immunisation of individuals from the age of 12 months and older against invasive meningococcal ACWY disease
22 September 2020 - Positive opinion based on a large, international clinical program demonstrating a good safety profile and a high ...
Posted by Michael Wonder on 22 Sep 2020
CHMP recommends approval of Supemtek (quadrivalent recombinant influenza vaccine) for the prevention of influenza in adults aged 18 years and older
22 September 2020 - Positive opinion based on clinical data demonstrating safety and efficacy of Supemtek for adults aged 18 and ...
Posted by Michael Wonder on 22 Sep 2020
Australia commits $123 million to a worldwide vaccine distribution alliance
22 September 2020 - Australia has committed $123 million to a worldwide vaccine distribution alliance, opening up the opportunity to ...
Posted by Michael Wonder on 22 Sep 2020
Taking steps toward transparency in real world evidence studies
22 September 2020 - The level of trust in health economics and outcomes research studies has been an on-going concern owing ...
Posted by Michael Wonder on 22 Sep 2020
Hikma updates on ANDA for generic Advair Diskus
22 September 2020 - Hikma Pharmaceuticals announces that it has received a minor complete response letter from the US FDA ...
Posted by Michael Wonder on 22 Sep 2020
Medeor Therapeutics’ transplant immune tolerance therapy receives regenerative medicine advanced therapy designation from FDA
22 September 2020 - Medeor Therapeutics today announced that the U.S. FDA has granted a regenerative medicine advanced therapy designation ...
Posted by Michael Wonder on 22 Sep 2020
U.S. FDA accepts for priority review Bristol Myers Squibb and bluebird bio application for anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Ide-cel, bb2121)
22 September 2020 - Ide-cel is the first CAR T cell therapy accepted for regulatory review for multiple myeloma. ...
Posted by Michael Wonder on 22 Sep 2020
Sanofi and GSK sign agreements with the Government of Canada to supply up to 72 million doses of adjuvanted COVID-19 vaccine
22 September 2020 - Agreements relate to vaccine candidate using Sanofi’s recombinant protein-based technology and GSK’s pandemic adjuvant. ...
Posted by Michael Wonder on 22 Sep 2020
FDA launches the Digital Health Center of Excellence
22 September 2020 - Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence ...
Posted by Michael Wonder on 22 Sep 2020
Gyroscope Therapeutics granted FDA fast track designation for GT005, an investigational gene therapy for dry age-related macular degeneration
22 September 2020 - Gyroscope Therapeutics today announced that the U.S. FDA has granted fast track designation to GT005 for the ...
Posted by Michael Wonder on 22 Sep 2020
ADC Therapeutics submits biologics license application to the U.S. FDA for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
21 September 2020 - Submission based on efficacy and safety data from LOTIS 2 clinical trial. ...
Posted by Michael Wonder on 22 Sep 2020
CHMP grants positive opinion for expanded use of Otsuka’s Deltyba (delamanid) in children and adolescents weighing at least 30 kg treated for pulmonary multi-drug resistant tuberculosis
21 September 2020 - This label extension of Deltyba (delamanid) represents a new treatment option for children and adolescents with pulmonary ...