Blog
RSS FeedPosted by Michael Wonder on 18 Aug 2019
Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakvi
17 August 2019 - Roche has priced its personalised cancer treatment, Rozlytrek, at about $17,050 per month, nearly half of ...
Posted by Michael Wonder on 18 Aug 2019
Roche drug approval offers a glimpse at the future of cancer treatment
15 August 2019 - The FDA on Thursday approved Roche’s cancer drug Rozlytrek for patients with any kind of tumour ...
Posted by Michael Wonder on 18 Aug 2019
EMA and FDA historically agree on just about every new drug approval, but is that slowly changing?
16 August 2019 - The EMA and US FDA concur more than 90% of the time in their decisions to ...
Posted by Michael Wonder on 18 Aug 2019
Novartis CEO says FDA process could have been handled better
17 August 2019 - Novartis AG Chief Executive Officer Vas Narasimhan said the company could have handled a furore surrounding ...
Posted by Michael Wonder on 17 Aug 2019
As Sarepta awaits approval of new Duchenne drug, big questions hang over therapy already on market
15 August 2019 - As Sarepta Therapeutics waits for the FDA to announce an approval decision on a new drug ...
Posted by Michael Wonder on 16 Aug 2019
FDA approves treatment for patients with rare bone marrow disorder
16 August 2019 - Today, the U.S. Food and Drug Administration approved Inrebic (fedratinib) capsules to treat adult patients with ...
Posted by Michael Wonder on 16 Aug 2019
Brexit's disruptive impact on U.K. and European prescription drug market
15 August 2019 - The new Prime Minister of Britain, Boris Johnson, is one of the more strident Brexiteers. He's ...
Posted by Michael Wonder on 16 Aug 2019
European Medicines Agency validates marketing application for filgotinib for the treatment of rheumatoid arthritis
15 August 2019 - Gilead Sciences and Galapagos today announced that the marketing authorisation application for filgotinib, an investigational, oral, ...
Posted by Michael Wonder on 16 Aug 2019
EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
16 August 2019 - EMA and the US FDA are aligned in more than 90% of marketing authorisation decisions for ...
Posted by Michael Wonder on 16 Aug 2019
AbbVie receives FDA approval of Rinvoq (upadacitinib), an oral JAK inhibitor for the treatment of moderate to severe rheumatoid arthritis
16 August 2019 - Approval supported by efficacy and safety data from one of the largest registrational Phase 3 programs in ...
Posted by Michael Wonder on 15 Aug 2019
Growing numbers of priority and competitive ANDAs under review as approvals trickle in
15 August 2019 - The US FDA on Wednesday released quarterly data on two of its programs aimed at increasing generic ...
Posted by Michael Wonder on 15 Aug 2019
FDA approves Genentech’s Rozlytrek (entrectinib) for people with ROS1-positive, metastatic non-small cell lung cancer and NTRK gene fusion-positive solid tumours
15 August 2019 - First FDA-approved treatment designed to target both ROS1 and NTRK that also shows response in cancer ...
Posted by Michael Wonder on 15 Aug 2019
The lengths Americans go to for cheap medicine
15 August 2019 - With drug prices soaring in the US, people are travelling to Canada to buy life-saving medication. ...
Posted by Michael Wonder on 15 Aug 2019
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumour
15 August 2019 - FDA also approves drug for second indication in a type of lung cancer. ...
Posted by Michael Wonder on 15 Aug 2019
Harmony Biosciences announces FDA approval of Wakix (pitolisant), a first-in-class medication for the treatment of excessive daytime sleepiness in adult patients with narcolepsy
15 August 2019 - Wakix represents the first and only non-scheduled treatment approved for patients with narcolepsy in the U.S. ...