Blog
RSS FeedPosted by Michael Wonder on 21 Jan 2021
Sanofi’s RSV treatment nirsevimab awarded PIM status
20 January 2021 - Sanofi’s nirsevimab has been awarded a Promising Innovative Medicine designation by the Medicines and Healthcare Products ...
Posted by Michael Wonder on 21 Jan 2021
Impel NeuroPharma announces U.S. FDA acceptance of new drug application for INP104 for the acute treatment of migraine
20 January 2021 - FDA conditionally accepts trade name, Trudhesa, pending approval of the new drug application, and sets PDUFA goal ...
Posted by Michael Wonder on 21 Jan 2021
Doptelet (avatrombopag) approved in the EU for treatment of ITP
20 January 2021 - Sobi today announced that the European Commission has approved an extension of the indication for Doptelet ...
Posted by Michael Wonder on 21 Jan 2021
With a new president and a new Congress, it's time for Medicare drug price negotiation
20 January 2021 - Since passage of the Medicare Modernization Act in 2003, which prohibited Medicare from negotiating prescription drug prices, ...
Posted by Michael Wonder on 20 Jan 2021
U.S. FDA accepts for priority review application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
20 January 2021 - U.S. FDA assigned a target action date of 25 May 2021. ...
Posted by Michael Wonder on 20 Jan 2021
U.S. Food and Drug Administration accepts for priority review application for Opdivo (nivolumab) as adjuvant therapy for patients with resected oesophageal or gastro-oesophageal junction cancer
20 January 2021 - Application based on Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival versus placebo in ...
Posted by Michael Wonder on 20 Jan 2021
AMA call for mass upscaling of home-made drug manufacture
20 January 2021 - The Australian Medical Association has warned of a shortage of essential medications because of supply chain ...
Posted by Michael Wonder on 20 Jan 2021
U.S. FDA approves vericiguat for patients with symptomatic chronic heart failure
20 January 2021 - Vericiguat (Verquvo) is the first soluble guanylate cyclase stimulator to be approved for the treatment of symptomatic ...
Posted by Michael Wonder on 20 Jan 2021
Scotland backs Roche’s Rozlytrek for ROS1 lung cancer
19 January 2021 - The Scottish Medicines Consortium has given a green light to Roche’s Rozlytrek for a rare form ...
Posted by Michael Wonder on 20 Jan 2021
Ontario doctors urge domestic drug manufacturing over fears of pandemic shortage
19 January 2021 - Chronic drug shortages have worsened during pandemic, Ontario Medical Association says. ...
Posted by Michael Wonder on 20 Jan 2021
Enhertu approved in the EU for the treatment of HER2 positive metastatic breast cancer
20 January 2021 - Approval based on the DESTINY-Breast01 Phase 2 trial which showed clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 20 Jan 2021
2021 April price disclosure cycle – indicative prices
20 January 2021 - Indicative 1 April 2021 prices resulting from the 2021 April Cycle of Price Disclosure have now been ...
Posted by Michael Wonder on 20 Jan 2021
Amryt’s Myalepta scores NICE backing for rare lipid disorder
20 January 2021 - NICE has recommended Amryt Pharma’s Myalepta (metreleptin) for use within the NHS. ...
Posted by Michael Wonder on 19 Jan 2021
New labelling for antibiotics in Australia
19 January 2021 - The Pharmaceutical Society of Australia is to be applauded for changing the way pharmacists label the antibiotics ...
Posted by Michael Wonder on 19 Jan 2021
Health professionals warn Australia is struggling to deal with post-COVID-19 medication shortage
20 January 2021 - Australians with chronic health conditions are having to take drastic stop-gap measures because of a continuing ...