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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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. ...

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'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 ...

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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 ...

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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) ...

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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 ...

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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 ...

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