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RSS FeedPosted by Michael Wonder on 30 May 2023
Roche Canada and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Vabysmo (faricimab injection) for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular oedema
29 May 2023 - Roche Canada today announced that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for ...
Posted by Michael Wonder on 30 May 2023
‘A victim of its own success’: inside the great Ozempic shortage
26 May 2023 - The drug is approved in Australia to treat type 2 diabetes but people have flocked to it ...
Posted by Michael Wonder on 29 May 2023
CHMP adopts positive opinion to extend the use of Veklury (remdesivir) to treat COVID-19 in people with severe renal impairment, including those on dialysis
26 May 2023 - If granted by the European Commission, Veklury will become the first and only authorised anti-viral treatment ...
Posted by Michael Wonder on 29 May 2023
Ipsen receives CHMP negative opinion, following re-examination of potential first FOP treatment in the EU
26 May 2023 - Regulatory processes are continuing in other countries including the US. ...
Posted by Michael Wonder on 29 May 2023
Once weekly Sogroya (somapacitan) receives CHMP positive opinion for expanded use in children and adolescents with growth hormone deficiency
26 May 2023 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending once weekly Sogroya ...
Posted by Michael Wonder on 29 May 2023
EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo
26 May 2023 - The EMA’s CHMP has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing ...
Posted by Michael Wonder on 29 May 2023
Lexicon announces FDA approval of Inpefa (sotagliflozin) for treatment of heart failure
26 May 2023 - Inpefa granted broad label across full range of left ventricular ejection fraction, including HFpEF and HFrEF, and ...
Posted by Michael Wonder on 29 May 2023
Marinus Pharmaceuticals receives positive CHMP opinion for Ztalmy (ganaxolone) for the adjunctive treatment of seizures associated with CDKL5 deficiency disorder
26 May 2023 - The European Commission decision is expected within 67 days of the CHMP opinion. ...
Posted by Michael Wonder on 29 May 2023
Ultomiris approved in Japan for the prevention of relapses in patients with neuromyelitis optica spectrum disorder
26 May 2023 - Ultomiris has the potential to eliminate relapses and redefine the treatment landscape for anti-aquaporin-4 (AQP4) antibody positive neuromyelitis ...
Posted by Michael Wonder on 29 May 2023
How China could choke EU supply of medicines
24 May 2023 - Europe relies on China for the production of certain key drugs such as antibiotics. ...
Posted by Michael Wonder on 28 May 2023
Bristol Myers Squibb receives positive CHMP opinion recommending approval for Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in patients with tumour cell PD-L1 expression ≥1%
26 May 2023 - Recommendation based on results from the Phase 3 CheckMate-816 trial, in which Opdivo with chemotherapy demonstrated improved ...
Posted by Michael Wonder on 27 May 2023
Highlights from the CHMP 22-25 May 2023 meeting
26 May 2023 - The EMA’s CHMP recommended two medicines for approval at its May 2023 meeting. ...
Posted by Michael Wonder on 26 May 2023
Takeda and HUTCHMED announce new drug application for fruquintinib for treatment of previously treated metastatic colorectal cancer granted priority review
25 May 2023 - PDUFA target action date set for 30 November 2023. ...
Posted by Michael Wonder on 25 May 2023
Gilead and Teva defend antitrust claims that prices for HIV medicines were unfairly kept high
25 May 2023 - Amid concern that HIV prevention pills are not being widely taken by those at highest risk ...
Posted by Michael Wonder on 25 May 2023
Milvexian granted US FDA fast track designation for all three indications under evaluation in Phase 3 Librexia program: ischaemic stroke, acute coronary syndrome and atrial fibrillation
25 May 2023 - The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development ...