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RSS FeedPosted by Michael Wonder on 12 May 2021
DermaSensor granted FDA breakthrough device designation
11 May 2021 - FDA designation fast tracks getting cancer detection device in the hands of healthcare professionals ...
Posted by Michael Wonder on 12 May 2021
Public availability of results of ClinicalTrials.gov registered expanded access studies
10 May 2021 - Expanded access is the use of investigational treatments outside of clinical trials. Results of expanded access studies ...
Posted by Michael Wonder on 11 May 2021
A shot at vaccine self-reliance via BioCina and University of Adelaide partnership
11 May 2021 - Australia could achieve total COVID-19 vaccine self-reliance within six months and produce enough synthetic vaccine to ...
Posted by Michael Wonder on 11 May 2021
The pharma industry needs to measure patient experience from the patients’ perspectives
10 May 2021 - The relationship between clinical outcomes and the patient experience — the sum of all of interactions ...
Posted by Michael Wonder on 11 May 2021
International IP protection at risk for COVID-19 vaccines
11 May 2021 - The global biotech industry is united in its drive for equitable access to COVID-19 vaccines, but ...
Posted by Michael Wonder on 11 May 2021
FDA grants fast track designation to CERC-002 for treatment of hospitalised patients with COVID-19
11 May 2021 - Cerecor today announced that the U.S. FDA has granted fast track designation to CERC-002 for treatment of ...
Posted by Michael Wonder on 11 May 2021
Avenda Health granted FDA breakthrough device designation for technology to treat prostate cancer
11 May 2021 - Avenda Health advances male “lumpectomy” for prostate cancer with new in office, AI based focal therapy system. ...
Posted by Michael Wonder on 11 May 2021
Additional measures to allow experts to focus on COVID-19 activities
11 May 2021 - EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network ...
Posted by Michael Wonder on 11 May 2021
BMS withdraws application for Opdivo/Yervoy combination
11 May 2021 - Details revealed in new AusPAR. ...
Posted by Michael Wonder on 11 May 2021
US, EU regulators discuss tailoring biosimilar approvals
11 May 2021 - A tailored approach to biosimilar approvals is conceived as the next big leap for regulatory advancement in ...
Posted by Michael Wonder on 10 May 2021
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic
10 May 2021 - Today, the U.S. FDA expanded the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine for the prevention ...
Posted by Michael Wonder on 10 May 2021
Smart Immune announces FDA orphan drug status, IND acceptance and fast track designation to commence Phase 1/2 clinical trial of proprietary allogeneic T cell progenitor product SMART 101 (ProTcell) for AML and ALL
10 May 2021 - Phase 1/2 trial to begin by fall 2021 at a top US cancer centre. ...
Posted by Michael Wonder on 10 May 2021
Amgen announces tezepelumab biologics license application submitted to U.S. FDA
10 May 2021 - Potential first in class medicine blocking TSLP, an epithelial sytokine. ...
Posted by Michael Wonder on 10 May 2021
Positive CHMP opinion for self-administered Crysvita
10 May 2021 - The EMA's CHMP has recommended Kyowa Kirin’s Crysvita for a new self-administration option to treat the ...
Posted by Michael Wonder on 10 May 2021
America wants to waive patent protection for vaccines
8 May 2021 - But it will not have an immediate effect on supplies. ...