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RSS FeedPosted by Michael Wonder on 09 Nov 2020
SMC - November 2020 decisions
9 November 2020 - Advice on eight new medicines for use in conditions including breast cancer, lung cancer and osteoporosis has ...
Posted by Michael Wonder on 09 Nov 2020
Impel Neuropharma announces FDA submission of new drug application for INP104 for the acute treatment of migraine
9 November 2020 - The INP104 new drug application is supported by results from the Phase 3 STOP 301 trial. ...
Posted by Michael Wonder on 09 Nov 2020
FDA grants rare paediatric disease designation to AMO Pharma for AMO-02 for treatment of congenital myotonic dystrophy
9 November 2020 - Designation qualifies AMO-02 for fast track review and AMO Pharma to receive a priority review voucher pending ...
Posted by Michael Wonder on 09 Nov 2020
Vary drug prices for different conditions, say health experts
9 November 2020 - The NHS could improve patients’ access to new cancer treatments by paying different prices for drugs ...
Posted by Michael Wonder on 09 Nov 2020
Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia
9 November 2020 - Calquence demonstrated superior progression-free survival and favourable tolerability in both previously untreated and relapsed or refractory ...
Posted by Michael Wonder on 09 Nov 2020
NICE issues positive Final Appraisal Determination for AbbVie’s Rinvoq (upadacitinib) in severe active rheumatoid arthritis
6 November 2020 - Positive recommendation means upadacitinib will be available to those with previously treated severe active rheumatoid arthritis. ...
Posted by Michael Wonder on 09 Nov 2020
Post-market review of medicines for smoking cessation – targeted stakeholder forum
9 November 2020 - A Stakeholder Forum will be held via webinar for the post-market review of medicines for smoking cessation ...
Posted by Michael Wonder on 09 Nov 2020
AFT welcomes US FDA complete response letter
9 November 2020 - AFT Pharmaceuticals today announces it has received a US FDA complete response letter covering its application ...
Posted by Michael Wonder on 09 Nov 2020
Makena indication may fall based on post-approval data
6 November 2020 - The US FDA is seeking to withdraw the approval of the only drug indicated to prevent ...
Posted by Michael Wonder on 08 Nov 2020
Midostaurin for treating advanced systemic mastocytosis
6 November 2020 - The Department of Health and Social Care has asked NICE to produce guidance on using midostaurin in ...
Posted by Michael Wonder on 07 Nov 2020
Ligand's partner Sedor Pharmaceuticals receives FDA approval for Sesquient for the treatment of status epilepticus in adult and paediatric patients
6 November 2020 - Captisol enabled product is stable at room temperature for timely administration at the point of patient care. ...
Posted by Michael Wonder on 07 Nov 2020
Bristol Myers Squibb receives European Commission approval for Opdivo (nivolumab) plus Yervoy (ipilimumab) with two cycles of chemotherapy for first-line treatment of metastatic non-small cell lung cancer
6 November 2020 - Approval based on Phase 3 CheckMate-9LA trial results showing superior overall survival in patients with metastatic non-small ...
Posted by Michael Wonder on 06 Nov 2020
Additional analysis of Kyprolis in the treatment of multiple myeloma
6 November 2020 - TLV has performed an additional analysis of Kyprolis (carfilzomib) when used in combination with lenalidomide and dexamethasone ...
Posted by Michael Wonder on 06 Nov 2020
NICE’s methods of technology evaluation - presenting a case for change
6 November 2020 - NICE has today launched a public consultation on proposals for changes to the methods it uses to ...
Posted by Michael Wonder on 06 Nov 2020
International regulators and WHO join forces to address COVID-19 challenges
6 November 2020 - The International Coalition of Medicines Regulatory Authorities and the World Health Organization have committed to working together ...