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RSS FeedPosted by Michael Wonder on 15 Jan 2021
Imfinzi approved in the EU for less frequent, fixed dose use in unresectable non-small cell lung cancer
15 January 2021 - New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 15 Jan 2021
Funding of pharmaceutical innovation during and after the COVID-19 pandemic
14 January 2021 - The COVID-19 pandemic has highlighted the available mechanisms for funding research, development, manufacturing, and distribution in the ...
Posted by Michael Wonder on 14 Jan 2021
Inhibrx granted fast track designation for INBRX-109 for the treatment of unresectable or metastatic conventional chondrosarcoma patients
13 January 2020 - Registration enabling study expected to begin dosing in the second or third quarter of this year. ...
Posted by Michael Wonder on 14 Jan 2021
The era of bipartisan work on lowering drug prices might be over
14 January 2021 - Dare we say it: The window for bipartisan work on drug pricing reform may be closed. ...
Posted by Michael Wonder on 14 Jan 2021
Innovation Pharmaceuticals’ brilacidin for the treatment of COVID-19 receives FDA fast track designation
14 January 2021 - Innovation Pharmaceuticals is pleased to announce that the U.S. FDA has designated as a fast track development ...
Posted by Michael Wonder on 14 Jan 2021
FDA veteran Woodcock being considered to lead agency under Biden
14 January 2021 - Joshua Sharfstein, former Obama FDA official, also in running. ...
Posted by Michael Wonder on 14 Jan 2021
Novartis ligelizumab (QGE031) receives FDA breakthrough therapy designation for patients with chronic spontaneous urticaria
14 January 2021 - Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria in patients ...
Posted by Michael Wonder on 14 Jan 2021
ViiV Healthcare receives EU marketing authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe
13 January 2021 - Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg ...
Posted by Michael Wonder on 14 Jan 2021
FDA releases artificial intelligence/machine learning action plan
12 January 2021 - Today, the U.S. FDA released the agency’s first artificial intelligence/machine learning-based software as a Medical Device Action ...
Posted by Michael Wonder on 14 Jan 2021
Workshop on evaluating RWE from observational studies in regulatory decision-making
12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...
Posted by Michael Wonder on 14 Jan 2021
Health Canada approves Imbruvica (ibrutinib) plus rituximab for the treatment of patients with chronic lymphocytic leukaemia
13 January 2021 - Patients aged 70 or younger with previously untreated CLL lived longer without disease progression compared to patients ...
Posted by Michael Wonder on 13 Jan 2021
Insights from the outcomes from the November 2020 PBAC meeting
14 January 2021 - What distinguishes an 'outcome' from an 'other matter?" ...
Posted by Michael Wonder on 13 Jan 2021
CADTH publishes initial recommendation for nivolumab for NSCLC
9 January 2021 - The pERC has conditionally recommended the reimbursement of nivolumab when used in combination with ipilimumab and ...
Posted by Michael Wonder on 13 Jan 2021
CADTH publishes initial pCODR recommendation for entrectinib
9 January 2021 - pERC has conditionally recommended the reimbursement of entrectinib for the first-line treatment of patients with ROS1 positive ...
Posted by Michael Wonder on 13 Jan 2021
Leading BioSciences announces FDA fast track designation granted to LB1148 for the treatment of post-operative gastro-intestinal dysfunction associated with paediatric cardiovascular surgery
13 January 2021 - LBS expects to initiate a pivotal trial in 2021. ...