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RSS FeedPosted by Michael Wonder on 25 Jul 2024
New clot busting drug recommended by NICE set to save NHS millions of pounds
24 July 2024 - Giving a new clot busting drug to people who have had a stroke could help save the ...
Posted by Michael Wonder on 25 Jul 2024
Kye Pharmaceuticals secures exclusive license, supply and commercialisation agreement with Catalyst Pharmaceuticals for Agamree, a novel treatment for Duchenne muscular dystrophy, in Canada
24 July 2024 - Kye Pharmaceuticals today announced that it has entered into a license, supply and commercialisation agreement with Catalyst ...
Posted by Michael Wonder on 25 Jul 2024
Switzerland’s drug approval process lags behind Europe
24 July 2024 - According to a recent study, medicines are approved on average 249 days later in Switzerland than by ...
Posted by Michael Wonder on 25 Jul 2024
Health Canada grants full approval to Jemperli for the treatment of patients with recurrent or advanced dMMR/MSI-H endometrial cancer
24 July 2024 - The conversion of this indication from Notice of Compliance to full approval is based on long term ...
Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
Posted by Michael Wonder on 25 Jul 2024
ConSynance Therapeutics receives FDA rare paediatric disease designation for CSTI-500 in Prader-Willi syndrome
24 July 2024 - ConSynance Therapeutics today announced that the US FDA has granted rare paediatric disease designation to its ...
Posted by Michael Wonder on 24 Jul 2024
Tiziana Life Sciences granted FDA fast track designation
24 July 2024 - Tiziana Life Sciences today announced the US FDA has granted fast track designation for its intranasal formulation ...
Posted by Michael Wonder on 24 Jul 2024
BioAtla granted FDA fast track designation for ozuriftamab vedotin (CAB-ROR2-ADC) for treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck
23 July 2024 - Ozuriftamab vedotin, the Company’s conditionally and reversibly active antibody drug conjugate directed against ROR2, has shown promising ...
Posted by Michael Wonder on 24 Jul 2024
Voydeya approved in Canada as add-on therapy to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia due to extravascular haemolysis
23 July 2024 - ALPHA Phase 3 trial showed first in class, oral, factor D inhibitor as add-on to Ultomiris ...
Posted by Michael Wonder on 24 Jul 2024
AbbVie's Epkinly receives first ever time-limited reimbursement recommendation by Canada's Drug Agency
23 July 2024 - AbbVie has successfully completed its negotiations with the pan-Canadian Pharmaceutical Alliance and a letter of intent ...
Posted by Michael Wonder on 24 Jul 2024
Fixing the reimbursement and coverage divide between ‘breakthrough’ drugs and medical devices
23 July 2024 - The FDA designates as “breakthrough” technologies certain drugs and devices. This designation helps expedite the development and ...
Posted by Michael Wonder on 23 Jul 2024
FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab)
22 July 2024 - Epysqli is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome. ...
Posted by Michael Wonder on 23 Jul 2024
Johnson & Johnson seeks US FDA approval of Spravato (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
22 July 2024 - Phase 4 Spravato monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at ...
Posted by Michael Wonder on 22 Jul 2024
Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for adalimumab-adbm injection, Boehringer’s biosimilar to Humira
18 July 2024 - First biosimilar with an exclusive low cash price on the GoodRx platform. ...
Posted by Michael Wonder on 22 Jul 2024
Why 10,000 Aussies a year being forced to fund their own cancer treatment
21 July 2024 - Australia’s medicine subsidy scheme is so crippled that a staggering 10,000 patients a year are being forced ...