Blog
RSS FeedPosted by Michael Wonder on 19 Jul 2024
Johnson & Johnson, BMS fight US drug price plan at Third Circuit
16 July 2024 - Pharmaceutical giants Johnson & Johnson, BMS and AstraZeneca are rejecting federal district court decisions that rule ...
Posted by Michael Wonder on 26 Jul 2024
European Commission approves Pfizer’s Durveqtix (fidanacogene elaparvovec), a one-time gene therapy for adults with haemophilia B
25 July 2024 - A one-time dose of Durveqtix has reduced bleeds post-treatment compared to standard of care with a median ...
Posted by Michael Wonder on 26 Jul 2024
US FDA approves BioMarin's Brineura (cerliponase alfa) for children under 3 years with CLN2 disease
24 July 2024 - Now approved for children of all ages with CLN2 Batten disease, regardless of whether they yet ...
Posted by Michael Wonder on 26 Jul 2024
Arcutis submits supplemental new drug application for Zorvye (roflumilast) foam to the FDA for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over
23 July 2024 - Once daily Zorvye foam significantly improved both scalp and body psoriasis in a Phase 2b and a ...
Posted by Michael Wonder on 25 Jul 2024
Drug middlemen push patients to pricier medicines, House probe finds
23 July 2024 - Findings from the House Oversight investigation add to criticism that pharmacy-benefit managers are driving up drug spending. ...
Posted 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
Jeff Shuren, medical devices head at FDA, to leave the agency
23 July 2024 - Jeffrey Shuren, longtime chief regulator of medical devices at the FDA, announced to staff on Tuesday ...
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 ...