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RSS FeedPosted by Michael Wonder on 31 Dec 2020
Tetra Bio-Pharma files new drug submission for Reduvo in Canada
30 December 2020 - The addressable market is estimated to be $80 million CDN by 2022. ...
Posted by Michael Wonder on 30 Dec 2020
Tiered drug pricing policy widens price difference among generic drugs
30 December 2020 - In July, the nation implemented a “tiered system” to restructure the drug-pricing method, which called for ...
Posted by Michael Wonder on 30 Dec 2020
Bristol Myers Squibb statement on Opdivo (nivolumab) small cell lung cancer U.S. indication
29 December 2020 - In 2018, Opdivo (nivolumab) was granted accelerated approval by the U.S. FDA for the treatment of patients ...
Posted by Michael Wonder on 30 Dec 2020
Zai Lab announces inclusion of Zejula (niraparib) in China’s National Reimbursement Drug List
28 December 2020 - Zai Lab today announced that Zejula has been included in the updated National Reimbursement Drug List released ...
Posted by Michael Wonder on 30 Dec 2020
BeiGene announces inclusion of three innovative oncology products in China National Reimbursement Drug List
27 December 2020 - Internally-developed anti-PD-1 antibody tislelizumab and BTK inhibitor Brukinsa (zanubrutinib) are included in the National Reimbursement Drug List ...
Posted by Michael Wonder on 30 Dec 2020
Junshi Biosciences announces inclusion of toripalimab in the China National Reimbursement Drug List
29 December 2020 - Junshi Biosciences is pleased to announce that toripalimab has been included in the updated National Reimbursement Drug ...
Posted by Michael Wonder on 30 Dec 2020
Osmotica Pharmaceuticals receives complete response letter from U.S. Food and Drug Administration for arbaclofen extended release tablets
29 December 2020 - Osmotica Pharmaceuticals today announced that the U.S. FDA has issued a complete response letter regarding the Company's ...
Posted by Michael Wonder on 30 Dec 2020
Novo Nordisk files for EU regulatory approval of once weekly semaglutide 2 mg for the treatment of type 2 diabetes mellitus
29 December 2020 - Novo Nordisk today announced the submission of a label extension application to the EMA for the existing ...
Posted by Michael Wonder on 29 Dec 2020
FDA accepts Alkermes' resubmission of new drug application for ALKS 3831
29 December 2020 - FDA sets PDUFA target action date of 1 June 2021. ...
Posted by Michael Wonder on 29 Dec 2020
European Medicines Agency validates Bristol Myers Squibb’s application for Zeposia (ozanimod) for the treatment of ulcerative colitis
28 December 2020 - Marketing authorisation application is supported by positive results from the pivotal Phase 3 True North trial evaluating ...
Posted by Michael Wonder on 29 Dec 2020
Janssen submits European marketing authorisation application for amivantamab for the treatment of patients with metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
28 December 2020 - If approved, amivantamab will be the first-ever treatment specifically targeting EGFR exon 20 insertion mutations in the ...
Posted by Michael Wonder on 29 Dec 2020
Lorbrena (lorlatinib) supplementary new drug application in previously untreated ALK positive lung cancer accepted for priority review by U.S. FDA
28 December 2020 - Supplemental new drug application being reviewed under FDA Real-Time Oncology Review and Project ORBIS pilot programs. ...
Posted by Michael Wonder on 29 Dec 2020
Cara Therapeutics submits new drug application to U.S. FDA for Korsuva injection in haemodialysis patients with moderate to severe pruritus
28 December 2020 - First NDA submission for Company’s lead program, Korsuva injection. ...
Posted by Michael Wonder on 28 Dec 2020
Chi-Med initiates rolling submission of NDA to U.S. FDA for surufatinib for the treatment of advanced neuroendocrine tumours
28 December 2020 - Company plans to complete rolling submission in the first half of 2021. ...
Posted by Michael Wonder on 28 Dec 2020
Life-saving cystic fibrosis miracle drug stuck in limbo
28 December 2020 - Lyla Gillard was diagnosed with cystic fibrosis, a deadly genetic disease that affects the lungs and ...