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 ...

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‘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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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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. ...

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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. ...

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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 ...

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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 ...

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