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RSS FeedPosted by Michael Wonder on 18 Mar 2017
AstraZeneca receives complete response letter from US FDA for ZS-9 (sodium zirconium cyclosilicate) for hyperkalaemia
17 March 2017 - AstraZeneca today announced that the US FDA has issued a complete response letter regarding the new ...
Posted by Michael Wonder on 18 Mar 2017
CAR-T drugs worth up to $649K in childhood leukaemia, says U.K. report
17 March 2017 - Health authorities in Britain ran cost-effectiveness numbers on pioneering CAR-T therapies that might be used to ...
Posted by Michael Wonder on 18 Mar 2017
Additional public summary documents from the November 2016 PBAC meeting
17 March 2017 - The public summary documents (first time rejections and deferrals) from the November 2016 PBAC meeting are ...
Posted by Michael Wonder on 17 Mar 2017
NICE recommends longer-lasting battery technology for implantable heart rhythm devices
17 March 2017 - People with heart failure are set to benefit from longer-lasting battery technology in implantable heart rhythm devices, ...
Posted by Michael Wonder on 17 Mar 2017
Shire receives European approval for label extension of Cinryze to prevent and treat hereditary angioedema (HAE) attacks in paediatric patients with HAE
16 March 2017 - Cinryze is now the first and only hereditary angioedema treatment approved for routine prevention in paediatrics. ...
Posted by Michael Wonder on 17 Mar 2017
NICE publishes draft guidance on the use of daratumumab (Darzalex) on the NHS
17 March 2017 - The Department of Health has asked NICE to produce guidance on the use of daratumumab as monotherapy ...
Posted by Michael Wonder on 16 Mar 2017
Call for feedback: new drugs for type 2 diabetes: second-line therapy : a therapeutic review update
15 March 2017 - A report on new drugs for second-line therapy for 2 diabetes: a therapeutic review update is now ...
Posted by Michael Wonder on 16 Mar 2017
Cardiome receives Notice of Compliance from Health Canada for its Brinavess NDS
14 March 2017 - Cardiome Pharma Corporation announced today that it received a Notice of Compliance for Brinavess (vernakalant hydrochloride, IV) ...
Posted by Michael Wonder on 16 Mar 2017
NICE gets go-ahead to fast-track more drug approvals
15 March 2017 - Patients will benefit from access to the most cost-effective treatments nearly 5 months faster after changes to ...
Posted by Michael Wonder on 16 Mar 2017
Marathon's $89,000 drug scrutinised for ‘unusual’ approval
16 March 2017 - Marathon Pharmaceuticals is under new scrutiny as Washington lawmakers press U.S. regulators about the “unusual circumstances” ...
Posted by Michael Wonder on 15 Mar 2017
NICE publishes draft guidance on the use of adalimumab and dexamethasone for uveitis
15 March 2017 - The Department of Health has asked NICE to produce guidance on the use of adalimumab and dexamethasone ...
Posted by Michael Wonder on 15 Mar 2017
Ipsen announces Health Canada approval of Dysport Therapeutic (abobotulinumtoxinA) for the treatment of patients with cervical dystonia and adult upper limb spasticity
14 March 2017 - Ipsen Biopharmaceuticals Canada today announced that Health Canada has approved Dysport Therapeutic (abobotulinumtoxinA) for the treatment ...
Posted by Michael Wonder on 15 Mar 2017
FDA approves Merck’s Keytruda (pembrolizumab) for adult and paediatric patients with classical Hodgkin lymphoma refractory to treatment, or who have relapsed after three or more prior lines of therapy
14 March 2017 - Only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat classical Hodgkin's lymphoma regardless of prior ...
Posted by Michael Wonder on 15 Mar 2017
Sanofi displeased with NICE decision on rare disease drug
14 March 2017 - French drug major Sanofi and its specialty care global business unit, Sanofi Genzyme, say they are ...
Posted by Michael Wonder on 15 Mar 2017
More options for pregnant women and 65+ to get funded influenza vaccines
15 March 2017 - Funded influenza vaccinations will be available from more community pharmacies this year. ...