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RSS FeedPosted by Michael Wonder on 04 Oct 2020
Kyowa Kirin announces European Commission approval of Crysvita (burosumab) for the treatment of X-linked hypophosphataemia in older adolescents and adults
2 October 2020 - More people in Europe are now eligible for treatment with Crysvita, the only therapy that targets the ...
Posted by Michael Wonder on 04 Oct 2020
Budget to deliver better access to life changing medicines for liver cancer, eye conditions and Parkinson’s disease
4 October 2020 - In Tuesday’s Budget, the Morrison Government will provide significant investment for new medicines including over $230 million ...
Posted by Michael Wonder on 02 Oct 2020
FDA approves drug combination for treating mesothelioma
2 October 2020 - First approval in 16 years for mesothelioma, a type of cancer caused by inhaling asbestos fibres. ...
Posted by Michael Wonder on 02 Oct 2020
Provention Bio files clinical module for teplizumab for the delay or prevention of clinical type 1 diabetes in at-risk individuals
30 September 2020 - Expect to complete filing of the rolling biologics license application for teplizumab in Q4 2020. ...
Posted by Michael Wonder on 02 Oct 2020
Patients, users, caregivers, and citizens' involvement in local health technology assessment unit in Quebec: a survey
29 September 2020 - The aim of the survey was to provide an overview of local health technology assessment unit practices ...
Posted by Michael Wonder on 02 Oct 2020
Farxiga granted breakthrough therapy designation in US for chronic kidney disease
2 October 2020 - Designation follows DAPA-CKD Phase 3 trial results in which Farxiga demonstrated unprecedented reduction in the risk of ...
Posted by Michael Wonder on 02 Oct 2020
HHS says Gilead, distributor can directly sell COVID-19 drug in U.S.
1 October 2020 - The U.S. Department of Health and Human Services said on Thursday that U.S. hospitals can now ...
Posted by Michael Wonder on 02 Oct 2020
EMA accepts regulatory submission for avalglucosidase alfa, a potentially new standard of care enzyme replacement therapy for Pompe disease
2 October 2020 - Submission based on positive data from two trials including both infantile-onset and late-onset Pompe disease patients. ...
Posted by Michael Wonder on 02 Oct 2020
Proposal to widen access to sirolimus for lymphovascular malformations and tuberous sclerosis complex complications
2 October 2020 - PHARMAC is seeking feedback on a proposal to widen funded access to sirolimus from 1 February ...
Posted by Michael Wonder on 02 Oct 2020
FDA grants fast track status to Aegle Therapeutics' AGLE-102 for the treatment of dystrophic epidermolysis bullosa
1 October 2020 - Aegle Therapeutics Corporation today announced the U.S. FDA has granted fast track designation to AGLE-102 for ...
Posted by Michael Wonder on 01 Oct 2020
EMA reminds physicians to use Tecentriq with nab-paclitaxel for treating breast cancer
1 October 2020 - EMA is reminding physicians to use Tecentriq (atezolizumab) only in combination with nab-paclitaxel and not with ...
Posted by Michael Wonder on 01 Oct 2020
Fostamatinib in chronic immune thrombocytopenia: added benefit not proven due to lack of comparison
1 October 2020 - Only placebo controlled studies in the dossier. ...
Posted by Michael Wonder on 01 Oct 2020
NICE backs Shionogi's Rizmoic
1 October 2020 - Shionogi's Rizmoic (naldemedine) will be available on the National Health Service to treat patients with opioid-induced ...
Posted by Michael Wonder on 01 Oct 2020
Fibristal (ulipristal acetate 5 mg tablets) voluntary withdrawal in Canada due to risk of drug-induced liver injury
30 September 2020 - Allergan is working closely with Health Canada to voluntarily withdraw Fibristal (ulipristal acetate 5 mg tablets) ...
Posted by Michael Wonder on 01 Oct 2020
Kadmon announces submission of new drug application to the U.S. FDA for belumosudil in patients with chronic graft versus host disease
30 September 2020 - Application being reviewed under FDA's Real-Time Oncology Review pilot program. ...