Blog
RSS FeedPosted by Michael Wonder on 22 Jul 2019
'I owe it everything': cancer drug approval win for rare cancers
23 July 2019 - Paul Hazelwood was told there was nothing else doctors could do to treat his rare terminal ...
Posted by Michael Wonder on 22 Jul 2019
FDA approves first generics of Lyrica
22 July 2019 - On July 19, the U.S. FDA approved multiple applications for first generics of Lyrica (pregabalin) for the ...
Posted by Michael Wonder on 22 Jul 2019
Vertex submits new drug application to the U.S. FDA for triple combination regimen of VX-445 (elexacaftor), tezacaftor and ivacaftor in cystic fibrosis
22 July 2019 - Application supported by positive results from two global Phase 3 studies in people with CF ages 12 ...
Posted by Michael Wonder on 21 Jul 2019
Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices
21 July 2019 - The objective was to develop and pilot a tool to measure and improve pharmaceutical companies’ clinical trial ...
Posted by Michael Wonder on 20 Jul 2019
Ted Cruz bill would speed FDA approval of drugs OK'd in other countries
18 July 2019 - Drugs and medical devices that have been authorised in other developed countries would face fast-track approval ...
Posted by Michael Wonder on 20 Jul 2019
Pear Therapeutics announces FDA submission for Somryst, a prescription digital therapeutic for the treatment of adults with chronic insomnia and depression
18 July 2019 - The pending submission is supported by data from two randomised controlled clinical trials of more than 1,400 ...
Posted by Michael Wonder on 20 Jul 2019
EMA takes note of the European Ombudsman’s decision on pre-submission activities
19 July 2019 - EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her ...
Posted by Michael Wonder on 20 Jul 2019
Biohaven's Nurtec (riluzole) 505(B)2 application for amyotrophic lateral sclerosis affected by issues related to Apotex plant: complete response letter received from FDA
20 July 2019 - FDA cited issues with the active pharmaceutical ingredient used in the Biohaven 2017 bioequivalence study that was ...
Posted by Michael Wonder on 20 Jul 2019
Amgen and Allergan's Mvasi (bevacizumab-awwb) and Kanjinti (trastuzumab-anns) now available in the United States
19 July 2019 - First biosimilar Avastin and Herceptin products to launch in the United States. ...
Posted by Michael Wonder on 20 Jul 2019
FDA approves Otezla (apremilast) for the treatment of oral ulcers associated with Behçet’s disease
19 July 2019 - With this third indication in the US, Otezla is the first and only treatment approved for oral ...
Posted by Michael Wonder on 20 Jul 2019
Blueprint Medicines announces European Medicines Agency validation of marketing authorisation application for avapritinib for the treatment of PDGFRα D842V mutant GIST and fourth-line GIST
18 July 2019 - Blueprint Medicines Corporation today announced that the EMA has validated the company's marketing authorisation application for avapritinib ...
Posted by Michael Wonder on 20 Jul 2019
EU starts evaluating Samsung Bioepis’ sales application for Avastin biosimilar
19 July 2019 - Samsung Bioepis said that the EMA has started evaluating its application to market SB8, an Avastin ...
Posted by Michael Wonder on 20 Jul 2019
Janssen seeks EMA approval for novel subcutaneous formulation of Darzalex (daratumumab)
19 July 2019 - Data supporting the application demonstrated that the investigational subcutaneous formulation improved quality of life, reduced administration time, ...
Posted by Michael Wonder on 19 Jul 2019
Patient registries may prove valuable in regulatory decisions, EMA study finds
18 July 2019 - Although patient registries can be heterogenous in their quality and design, a new study in Drug ...
Posted by Michael Wonder on 19 Jul 2019
Was it really a smart move for the FDA to approve a ‘smart pill’ for treating schizophrenia?
18 July 2019 - In late 2017, the FDA approved the first so-called smart pill, ushering in a new era ...