Blog
RSS FeedPosted by Michael Wonder on 24 Jul 2021
Dalvance (dalbavancin) receives FDA approval to treat acute bacterial skin and skin structure infections in paediatric patients
23 July 2021 - Dalvance is the first and only single dose infusion to treat acute bacterial skin and skin structure ...
Posted by Michael Wonder on 23 Jul 2021
Most clinical trials failed to meet U.S. transparency requirements for recently approved drugs
22 July 2021 - In the latest look at clinical trial transparency, a new analysis found that only 26% of ...
Posted by Michael Wonder on 23 Jul 2021
‘When memory fades’: misinformation about Alzheimer’s disease and Aduhelm must be limited
21 July 2021 - Surgeon General Vivek Murthy issued a timely and thought-provoking advisory about the serious threat to public ...
Posted by Michael Wonder on 23 Jul 2021
TGA hopes to approve Moderna COVID-19 vaccine by early August
23 July 2021 - Therapeutic Goods Administration head John Skerritt said the Moderna vaccine looked promising, but he was still ...
Posted by Michael Wonder on 23 Jul 2021
TGA provisional approval of Pfizer-BioNTech COVID-19 vaccine to include 12-15 year age group
23 July 2021 - The TGA has provisionally approved the use of the Pfizer BNT162b2 COVID-19 vaccine (Comirnaty) in individuals 12 ...
Posted by Michael Wonder on 23 Jul 2021
GBT provides regulatory and pipeline updates in sickle cell disease
22 July 2021 - Submits supplemental new drug application to the U.S. FDA for Oxbryta (voxelotor) in children with SCD ages ...
Posted 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. ...