Outcomes from the May 2024 PBAC intracycle meeting

21 June 2024 - Recommendations made by the PBAC in May 2024 relating to the listing of medicines on the PBS ...

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Paediatric rare disease drug Qarziba gets green light for coverage

30 May 2024 - The Health Insurance Review and Assessment Service (HIRA) held its fourth Cancer Disease Review Committee (CDRC) ...

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Bavarian Nordic submits supplemental BLA seeking US FDA approval of freeze dried formulation of smallpox and mpox vaccine

31 May 2024 - Bavarian Nordic today announced the submission of a supplemental biologics license application to the US FDA ...

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Biogen receives European Commission approval for Qalsody (tofersen), the first therapy to treat a rare, genetic form of ALS

30 May 2024 - Qalsody is Biogen’s third rare disease therapy to be approved in the EU, demonstrating the company’s commitment ...

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New pharmacy agreement delivers cheaper medicines

3 June 2024 - The Albanese Government and the Pharmacy Guild of Australia have signed the eighth Community Pharmacy Agreement ...

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Tagrisso with the addition of chemotherapy recommended for approval in the EU by CHMP for patients with EGFR mutated advanced lung cancer

3 June 2024 - Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...

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Johnson & Johnson submits application to the EMA seeking approval of subcutaneous formulation of Rybrevant (amivantamab) for the treatment of patients with EGFR mutated non-small cell lung cancer

31 May 2024 - Submission is supported by data from the Phase 3 PALOMA-3 study featured at the American Society of ...

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Update on FDA priority review of Dupixent (dupilumab) for the treatment of COPD patients with type 2 inflammation

31 May 2024 - Regeneron Pharmaceuticals and Sanofi today announced the US FDA has extended by three months the target action ...

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Tris Pharma receives US FDA approval for once daily Onyda XR (clonidine hydrochloride) extended release oral suspension, the first and only liquid non-stimulant ADHD medication

29 May 2024 - First non-stimulant ADHD medication, with nighttime dosing, adds to Tris Pharma’s established portfolio of leading ADHD therapies ...

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Project Orbis: quicker access to promising cancer treatments

29 May 2024 - Scientific analysis confirms successful Swissmedic participation in international initiative to expedite access to innovative cancer drugs. ...

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Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo for the treatment of IgA nephropathy

30 May 2024 - Calliditas Therapeutics today announced that the CHMP of the EMA adopted a positive opinion recommending the ...

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Teva announces Austedo XR (deutetrabenazine) extended release tablets now US FDA approved as a one pill, once daily treatment option for clinically therapeutic doses (24 mg–48 mg/day)

29 May 2024 - US FDA approves new one pill, once daily Austedo XR tablets (30 mg, 36 mg, 42 ...

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Zanidatamab granted priority review for HER2 positive metastatic biliary tract cancer

29 May 2024 - Target action (PDUFA) date set for 29 November 2024. ...

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Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency

31 May 2024 - Zealand Pharma today announced that the CHMP of the EMA has issued a positive opinion recommending granting ...

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Mirum Pharmaceuticals announces positive CHMP opinion for Livmarli (maralixibat) oral solution for the treatment of PFIC in patients three months of age and older

31 May 2024 - Positive opinion from CHMP based on Phase 3 MARCH study with highly statistically significant (p<0.0001) reduction in ...

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US FDA acknowledges Astellas' resubmission of biologics license application for zolbetuximab and sets new action date

30 May 2024 - If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and ...

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