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RSS FeedPosted by Michael Wonder on 28 Sep 2021
European Medicines Agency grants Atara Biotherapeutics accelerated assessment of tab-cel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
27 September 2021 - Atara on track to submit MAA in November 2021. ...
Posted by Michael Wonder on 27 Sep 2021
Gilead marks fifth approval for Trodelvy in metastatic triple negative breast cancer under Project Orbis initiative with Health Canada authorisation
27 September 2021 - Antibody-drug conjugate Trodelvy is first treatment to show survival benefit versus standard of care in metastatic triple ...
Posted by Michael Wonder on 27 Sep 2021
Canadian cancer patients have new affordable treatment option
27 September 2021 - Apobiologix expanded its leadership in Canada's biosimilar market with the approval of its first therapeutic treatment, Bambevi. ...
Posted by Michael Wonder on 27 Sep 2021
U.S. Food and Drug Administration accepts Bristol Myers Squibb’s applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + chemotherapy for unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma
27 September 2021 - Applications based on Phase 3 CheckMate-648 trial, in which both Opdivo-based combinations demonstrated a significant overall survival ...
Posted by Michael Wonder on 27 Sep 2021
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax
27 September 2021 - EMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s ...
Posted by Michael Wonder on 26 Sep 2021
Australia secures supply of drug that treats arthritis and Covid
25 September 2021 - Health Minister Greg Hunt has secured an extra supply of a rheumatoid arthritis drug to treat critically ...
Posted by Michael Wonder on 26 Sep 2021
FDA tweaks biosimilar application review program
25 September 2021 - The FDA has struggled during the COVID-19 pandemic to conduct timely reviews of biosimilar approval applications. ...
Posted by Michael Wonder on 25 Sep 2021
CARISMA Therapeutics announces U.S. FDA grants fast track designation to CT-0508 for the treatment of patients with solid tumours
22 September 2021 - CARISMA Therapeutics announced today that that the U.S. FDA has granted fast track designation to CT-0508, ...
Posted by Michael Wonder on 25 Sep 2021
FDA approves Repatha (evolocumab) in paediatric patients age 10 and older with heterozygous familial hypercholesterolaemia
24 August 2021 - Approval based on HAUSER RCT demonstrating a significant reduction in low-density lipoprotein cholesterol. ...
Posted by Michael Wonder on 25 Sep 2021
Vertex's supplement to a new drug submission for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene accepted for priority review by Health Canada
22 September 2021 - Vertex Pharmaceuticals today announced its supplement to a new drug submission for Kalydeco (ivacaftor) has been ...
Posted by Michael Wonder on 25 Sep 2021
Pfizer and OPKO announce extension of U.S. FDA review of biologics license application of somatrogon for paediatric growth hormone deficiency
24 September 2021 - 4, 2021 - Pfizer and OPKO Health announced today that the U.S. FDA has extended the review ...
Posted by Michael Wonder on 24 Sep 2021
ATAGI update following weekly COVID-19 meeting (22 September 2021)
24 September 2021 - An update from the Australian Technical Advisory Group on Immunisation following their weekly meeting on 22 September ...
Posted by Michael Wonder on 24 Sep 2021
EU drugs regulator to decide on Pfizer vaccine booster in early October
23 September 2021 - The EMA aims to decide in early October whether to endorse a third dose of the ...
Posted by Michael Wonder on 24 Sep 2021
Ascentage Pharma's MDM2-p53 inhibitor alrizomadlin (APG-115) granted fast track designation by the US FDA for the treatment of relapsed/refractory unresectable or metastatic melanoma
22 September 2021 - Ascentage Pharma today announced that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been granted a fast track ...
Posted by Michael Wonder on 23 Sep 2021
A middle ground for accelerated drug approval—lessons from aducanumab
23 September 2021 - The accelerated approval by the US FDA of Biogen’s monoclonal antibody aducanumab (Aduhelm) for treatment of patients ...