Blog
RSS FeedPosted by Michael Wonder on 24 Apr 2021
CHMP recommends EU approval of Roche’s Enspryng (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder
23 April 2021 - Recommendation is based on results from the two pivotal Phase 3 SAkuraStar and SAkuraSky trials, in which ...
Posted by Michael Wonder on 23 Apr 2021
FDA authorises marketing of device to facilitate muscle rehabilitation in stroke patients
23 April 2021 - Today, the U.S. FDA authorised marketing of a new device indicated for use in patients 18 and ...
Posted by Michael Wonder on 23 Apr 2021
FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma
23 April 2021 - Today the FDA granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics), a CD19-directed antibody and alkylating ...
Posted by Michael Wonder on 23 Apr 2021
Roche receives FDA approval for first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy
23 April 2021 - VENTANA MMR RxDx Panel is the first immunohistochemistry predictive test in endometrial cancer for treatment with the ...
Posted by Michael Wonder on 23 Apr 2021
Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderns
23 April 2021 - EMA’s human medicines committee (CHMP) has adopted two important recommendations that will increase manufacturing capacity and supply ...
Posted by Michael Wonder on 23 Apr 2021
AbbVie receives Health Canada approval of Humira (adalimumab) for the treatment of paediatric patients with moderately to severely active ulcerative colitis
22 April 2021 - Approval based on results from the pivotal Phase 3 ENVISION I trial, the largest clinical trial in ...
Posted by Michael Wonder on 22 Apr 2021
FDA approves immunotherapy for endometrial cancer with specific biomarker
22 April 2021 - Today, the U.S. FDA granted accelerated approval to Jemperli (dostarlimab) for treating patients with recurrent or advanced ...
Posted by Michael Wonder on 22 Apr 2021
WHO and EMA to inspect Sputnik V manufacturing in May
22 April 2021 - Technical experts from the World Health Organization are due to start the next round of their ...
Posted by Michael Wonder on 22 Apr 2021
The TGA claims Tenofovir Emtricitabine Sandoz is a first generic but is it?
22 April 2021 - Closer examination suggests otherwise. ...
Posted by Michael Wonder on 22 Apr 2021
TGA publishes AusPAR for Zolgensma
22 April 2021 - Rapid publication following approval. ...
Posted by Michael Wonder on 22 Apr 2021
Allogene Therapeutics announces FDA regenerative medicine advanced therapy designation granted to ALLO-715, an AlloCAR T cell therapy in development for relapsed/refractory multiple myeloma
21 April 2021 - Regenerative medicine advanced therapy designation follows proof of concept data from ALLO-715 UNIVERSAL trial in heavily pretreated, ...
Posted by Michael Wonder on 21 Apr 2021
“Dangling” accelerated approvals in oncology
21 April 2021 - The FDA recently reevaluated accelerated approvals for 35 oncology indications for anti–programmed death ligand 1 antibodies, revealing ...
Posted by Michael Wonder on 21 Apr 2021
FDA continues important steps to ensure quality, safety and effectiveness of authorised COVID-19 vaccines
21 April 2021 - The U.S. FDA takes its responsibility to ensure medical product quality, safety and effectiveness very seriously. ...
Posted by Michael Wonder on 21 Apr 2021
J&J resumes roll-out of COVID-19 vaccine in EU
21 April 2021 - Johnson & Johnson is planning to resume the roll-out of its COVID-19 vaccine in the EU ...
Posted by Michael Wonder on 21 Apr 2021
Medtronic receives U.S. FDA approval for pipeline flex embolisation device with shield technology
21 April 2021 - First patient receives new shield surface modification, an advance in flow diversion therapy, at NYU Langone Health. ...