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RSS FeedPosted 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
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
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 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
America wants to waive patent protection for vaccines
8 May 2021 - But it will not have an immediate effect on supplies. ...
Posted by Michael Wonder on 09 May 2021
‘In their own bubble’: How a cancer center promoted an exclusive experimental drug to attract patients
6 May 2021 - A new medication for children with a rare and life-threatening cancer called neuroblastoma had a curious ...
Posted by Michael Wonder on 09 May 2021
US wary of boosting China biotech with COVID vaccine patent waiver
9 May 2021 - The Biden administration is examining ways to ensure that a waiver of COVID-19 vaccine patents to ...
Posted by Michael Wonder on 08 May 2021
AstraZeneca weighs seeking full U.S. approval for COVID-19 shot, skipping emergency use application
7 May 2021 - British drugmaker faces challenges gathering data; may wait to apply for full approval by the FDA, which ...
Posted by Michael Wonder on 07 May 2021
Pfizer and BioNTech initiate rolling submission of biologics license application for U.S. FDA approval of their COVID-19 vaccine
7 May 2021 - - Pfizer and BioNTech today announced the initiation of a biologics license application with the U.S. FDA ...
Posted by Michael Wonder on 06 May 2021
The difference between an interchangeable biosimilar and one that isn't
5 May 2021 - Permitting automatic substitution of biosimilars for originator brand biologics at the pharmacy counter is often talked about ...
Posted by Michael Wonder on 06 May 2021
Viome receives FDA approval for its unique mRNA technology and AI platform to detect cancers
6 May 2021 - FDA breakthrough designation validates Viome's proprietary mRNA analysing technology and state of the art AI platform to ...
Posted by Michael Wonder on 06 May 2021
Injectafer (ferric carboxymaltose injection) receives FDA approval for single dose option for the treatment of adult patients with iron deficiency anaemia
6 May 2021 - For patients weighing 50 kg (110 lb) or more, Injectafer may now be administered as a 1000 ...