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RSS FeedPosted by Michael Wonder on 10 Dec 2020
Switzerland ramps up COVID-19 vaccine order
9 December 2020 - Switzerland has increased its coronavirus vaccine order with Moderna by three million doses. ...
Posted by Michael Wonder on 10 Dec 2020
FDA accepts GSK’s filing of Nucala (mepolizumab) for use in chronic rhinosinusitis with nasal polyps
8 December 2020 - If approved, Nucala would be the only treatment approved in the US for use in four eosinophil-driven ...
Posted by Michael Wonder on 10 Dec 2020
Hackers steal Pfizer/BioNTech COVID-19 vaccine data in Europe, companies say
10 December 2020 - U.S. drug maker Pfizer and its German partner BioNTech said on Wednesday that documents related to development ...
Posted by Michael Wonder on 10 Dec 2020
Valeo Pharma announces Health Canada approval for Redesca and Redesca Hp
9 December 2020 - Valeo Pharma announced today that Health Canada has issued a Notice of Compliance for Redesca and ...
Posted by Michael Wonder on 10 Dec 2020
Proposal to widen access to febuxostat for prevention of tumour lysis syndrome
10 December 2020 - PHARMAC is seeking feedback on a proposal to widen access to febuxostat tablets. ...
Posted by Michael Wonder on 09 Dec 2020
BeiGene announces the approval in China of Blincyto (blinatumomab) for injection for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
7 December 2020 - BeiGene today announced that the China NMPA has approved Blincyto (blinatumomab) for injection for the treatment of ...
Posted by Michael Wonder on 09 Dec 2020
Most favoured nation drug pricing rule will harm patient access and jeopardise practice stability, rheumatology leaders warn
9 December 2020 - The American College of Rheumatology today warned that the CMS interim final rule establishing a “most favoured ...
Posted by Michael Wonder on 09 Dec 2020
America is subsidising Europe's socialist medicine — with higher drug prices here
8 December 2020 - President Trump finalised a “most favoured nation” , or “best price,” prescription drug-pricing rule on 20 ...
Posted by Michael Wonder on 09 Dec 2020
'We're feeling broken': Taranaki father of six dies after battle for cancer drug funding
10 December 2020 - A Taranaki father who fought to get vital cancer drugs funded by the Government has lost his ...
Posted by Michael Wonder on 09 Dec 2020
Amgen's sotorasib granted breakthrough therapy designation for advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation
8 December 2020 - Sotorasib also accepted into FDA's Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 09 Dec 2020
Albireo submits for U.S. FDA and EMA product approval of once daily odevixibat for PFIC
8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients. ...
Posted by Michael Wonder on 09 Dec 2020
Even before year end, 2020's new drug approvals match FDA's 2019 stats
7 December 2020 - The US FDA has kept its new drug approvals for 2020 on track to match or ...
Posted by Michael Wonder on 08 Dec 2020
Turning Point Therapeutics granted FDA breakthrough therapy designation for repotrectinib treatment in patients with ROS1 positive metastatic non-small cell lung cancer who have not been treated with a ROS1 tyrosine kinase inhibitor
8 December 2020 - Updated data from TRIDENT-1 study in tyrosine kinase inhibitor naïve patients with ROS1 positive non-small cell lung ...
Posted by Michael Wonder on 08 Dec 2020
Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025
8 December 2020 - The EMA and the Heads of Medicines Agencies (HMA) have published their joint strategy for ...
Posted by Michael Wonder on 08 Dec 2020
Three reasons the drug industry should be worried about Biden’s HHS pick, Xavier Becerra
8 December 2020 - For a pharmaceutical industry that has spent two years sparring with health secretary Alex Azar, a ...