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RSS FeedPosted by Michael Wonder on 22 Jul 2021
Novartis aims to beat rivals to novel $10 billion cancer treatment market
22 July 2021 - Trial results for new targeted therapy ‘pretty remarkable’, says CEO. ...
Posted by Michael Wonder on 22 Jul 2021
TGA set to greenlight Pfizer jab for children aged between 12 and 16 year old
23 July 2021 - Australia’s drug regulator is reportedly set to greenlight the Pfizer COVID vaccine for the country’s children, ...
Posted by Michael Wonder on 22 Jul 2021
FDA approves treatment for paediatric patients with type 2 diabetes mellitus
22 July 2021 - The U.S. FDA today approved Bydureon and Bydureon BCise (exenatide extended release) injection to be used in ...
Posted by Michael Wonder on 22 Jul 2021
Roche is discussing Alzheimer’s drug with FDA following regulators controversial approval of Biogen’s Aduhelm, CEO says
22 July 2021 - Roche is discussing its potential Alzheimer’s treatment with the U.S. FDA, CEO Severin Schwan said Thursday, ...
Posted by Michael Wonder on 22 Jul 2021
FDA approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination for patients with certain types of advanced endometrial carcinoma
22 July 2021 - Immunotherapy and tyrosine kinase inhibitor combination approved for the treatment of patients with advanced endometrial carcinoma that ...
Posted by Michael Wonder on 22 Jul 2021
Bayer’s new symptomatic chronic heart failure treatment Verquvo (vericiguat) approved in EU
21 July 2021 - Approved for adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring ...
Posted by Michael Wonder on 22 Jul 2021
bluebird bio receives EC approval for Skysona (elivaldogene autotemcel, Lenti-D) gene therapy for patients less than 18 years of age with early cerebral adrenoleukodystrophy without matched sibling donor
21 July 2021 - Skysona is the first and only gene therapy approved in the European Union to treat early CALD. ...
Posted by Michael Wonder on 22 Jul 2021
COVID-19 vaccine weekly safety report (22 July 2021)
22 July 2021 - Over the last week, four additional cases of blood clots with low blood platelets have been assessed ...
Posted by Michael Wonder on 21 Jul 2021
We’re seeing what happens when the FDA loses credibility
21 July 2021 - It’s not just politicians who are worried about the decision to approve a new Alzheimer’s drug. ...
Posted by Michael Wonder on 21 Jul 2021
Fit for purpose real world data assessments in oncology: a call for cross stakeholder collaboration
21 July 2021 - Real world evidence remains a promising frontier in evidence generation to support improved health related patient outcomes. ...
Posted by Michael Wonder on 21 Jul 2021
Recently approved Alzheimer drug raises questions that might never be answered
21 July 2021 - The FDA’s approval June 7 of the drug aducanumab was notable for a number of reasons. ...
Posted by Michael Wonder on 21 Jul 2021
Pfizer provides update on U.S. FDA review of abrocitinib and Xeljanz filings
21 July 2021 - Pfizer announced today that the U.S. FDA has notified the company that it will not meet the ...
Posted by Michael Wonder on 21 Jul 2021
How an unproven Alzheimer’s drug got approved
19 July 2021 - Though some of its own senior officials said there was little evidence of benefit for patients, the ...
Posted by Michael Wonder on 21 Jul 2021
Myovant Sciences announces European Commission approval for Ryeqo for the treatment of women with uterine fibroids
20 July 2021 - Ryeqo is the first and only once-daily long-term treatment for uterine fibroids in Europe. ...
Posted by Michael Wonder on 21 Jul 2021
EMA publishes agenda for 19-22 July CHMP meeting
19 July 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...