Blog
RSS FeedPosted by Michael Wonder on 19 Mar 2019
FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection
19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...
Posted by Michael Wonder on 18 Mar 2019
Reimbursement for orphan drug Spinraza imminent
18 March 2019 - Biogen’s Spinraza (nusinersen), a treatment for spinal muscular atrophy, is likely to obtain reimbursement as early ...
Posted by Michael Wonder on 18 Mar 2019
Allergan announces FDA approval of Avycaz (ceftazidime and avibactam) for paediatric patients
18 March 2019 - Label now includes new data on use of Avycaz for treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 12 Mar 2019
FDA approves Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adolescents
11 March 2019 - Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation ...
Posted by Michael Wonder on 10 Mar 2019
Family of sick toddler launches petition urging PHARMAC to fund life-extending drug Spinraza
10 March 2019 - A Pukekohe family has launched a petition urging PHARMAC to fund a drug for spinal muscular ...
Posted by Michael Wonder on 08 Mar 2019
FDA accepts supplemental biologics license applications for Botox (onabotulinumtoxinA) for paediatric patients with upper and lower limb spasticity
7 March 2019 - Applications seek to extend use of Botox for patients 2 to 17 years old. ...
Posted by Michael Wonder on 06 Mar 2019
In UK and Ireland, SMA patients demand reimbursement for Spinraza
6 March 2019 - A drug appraisal committee of Britain’s NICE met in Manchester, England, for the third and final ...
Posted by Michael Wonder on 06 Mar 2019
FDA grants rare paediatric disease designation to odiparcil for the treatment of MPS VI
5 March 2019 - Inventiva eligible to receive priority review voucher upon approval of odiparcil for the treatment of MPS VI. ...
Posted by Michael Wonder on 04 Mar 2019
Panel backs provincial funding for expensive drug to treat rare disease. But only for children.
4 March 2019 - Provincial governments should expand public funding for one of the world’s most expensive medications to cover ...
Posted by Michael Wonder on 03 Mar 2019
Biogen responds to CADTH’s updated recommendation regarding coverage for Spinraza
1 March 2019 - CADTH has expanded their recommendations for public reimbursement for SMA patients. ...
Posted by Michael Wonder on 27 Feb 2019
'Depriving sick babies of right to life' - NZORD boss blasts PHARMAC decision to defer Spinraza
28 February 2019 - Clinical experts deciding whether to fund a drug that would prolong the life of babies with ...
Posted by Michael Wonder on 21 Feb 2019
AbbVie's Humira (adalimumab) approved by Health Canada to treat paediatric patients with chronic non-infectious anterior uveitis
20 February 2019 - The approval marks Humira as the only approved biologic treatment option in Canada for paediatric patients from ...
Posted by Michael Wonder on 18 Feb 2019
Decision on spinal muscular atrophy treatment Spinraza deferred
18 February 2019 - PHARMAC's decision to defer a decision on funding the only treatment for spinal muscular atrophy (SMA) ...
Posted by Michael Wonder on 14 Feb 2019
Eisai submits application in Europe seeking approval for Fycompa as treatment for paediatric patients with epilepsy
13 February 2019 - Eisai announced today that it has submitted an application to the EMA for its in-house discovered ...
Posted by Michael Wonder on 11 Feb 2019
Clementia granted rare paediatric disease designation by FDA for palovarotene for fibrodysplasia ossificans progressiva
11 February 2019 - Clementia Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to palovarotene for ...