Blog
RSS FeedPosted by Michael Wonder on 06 Mar 2021
U.S. FDA approves Yescarta for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...
Posted by Michael Wonder on 06 Mar 2021
Genentech’s Actemra becomes the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis associated interstitial lung disease, a rare, debilitating condition
4 March 2021 - The U.S. FDA previously granted priority review designation to Actemra for the treatment of systemic sclerosis-associated ...
Posted by Michael Wonder on 05 Mar 2021
ICER publishes final evidence report and policy recommendations on roxadustat
5 March 2021 - Independent appraisal committee determines the evidence is not adequate to demonstrate that roxadustat provides a net ...
Posted by Michael Wonder on 05 Mar 2021
PBAC Public Summary Documents - November 2020 meeting
5 March 2021 - The Public Summary Documents (positive recommendations and subsequent decisions not to recommend) from the November 2020 PBAC ...
Posted by Michael Wonder on 04 Mar 2021
Ofev (nintedanib) receives positive recommendation from CADTH and INESSS for the treatment of progressive fibrosing interstitial lung diseases
4 March 2021 - Ofev is the first treatment available in Canada for chronic fibrosing interstitial lung diseases with a progressive ...
Posted by Michael Wonder on 04 Mar 2021
FDA approves Accu-Joint hemi implant, a hemi-arthroplasty metatarsal head or phalangeal base implant for the metatarsophalangeal joint
2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...
Posted by Michael Wonder on 04 Mar 2021
U.S. FDA expands approval of Pfizer's Lorbrena as first-line treatment for ALK positive metastatic lung cancer
3 March 2021 - Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or ...
Posted by Michael Wonder on 04 Mar 2021
NICE rejects rare blood cancer treatment Poteligeo in final appraisal
4 March 2021 - The UK’s NICE has not recommended Kyowa Kirin’s Poteligeo for the treatment of adults living with ...
Posted by Michael Wonder on 03 Mar 2021
FDA grants de novo to ML-based, real-time indicator of patient deterioration
2 March 2021 - Fifth Eye's non-invasive tool is the first to provide continuous monitoring of haemodynamic status using a single ...
Posted by Michael Wonder on 03 Mar 2021
NICE backs NHS use of Lilly’s Olumiant in eczema
3 March 2021 - Eli Lilly’s Olumiant has received a UK NICE recommendation for the treatment of moderate-to-severe atopic dermatitis ...
Posted by Michael Wonder on 03 Mar 2021
Health Canada approves Brukinsa (zanubrutinib) for the treatment of Waldenström’s macroglobulinaemia
2 March 2021 - Approval is based on the Phase 3 ASPEN trial of Brukinsa compared to ibrutinib. ...
Posted by Michael Wonder on 03 Mar 2021
Relivion wearable brain neuromodulation technology cleared by FDA for the treatment of migraine
2 March 2021 - Relivion is the only non-invasive multi-channel neuromodulation technology for the treatment of acute migraine. ...
Posted by Michael Wonder on 02 Mar 2021
ICER publishes Final Evidence Report and policy recommendations on new therapies for high cholesterol
2 March 2021 - For bempedoic acid, independent appraisal committee votes that the evidence is not adequate to demonstrate a net ...
Posted by Michael Wonder on 02 Mar 2021
Merck provides update on Keytruda (pembrolizumab) indication in metastatic small cell lung cancer in the US
1 March 2021 - Merck today announced the company is voluntarily withdrawing the U.S. indication for Keytruda (pembrolizumab) for the treatment ...
Posted by Michael Wonder on 02 Mar 2021
Apollo Endosurgery Receives FDA breakthrough device designation for the Orbera intragastric balloon for treatment of patients with NASH
1 March 2021 - Apollo Endosurgery announced today that it has received a breakthrough device designation from the U.S. FDA for ...