Traditional cost effectiveness formulas and precision medicines

 1 June 2020 - Cost effectiveness analyses, which are often conducted to evaluate new medicines, use a standardised framework to ...

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Lynparza recommended for approval in EU by CHMP for BRCA mutated metastatic pancreatic cancer

1 June 2020 - Only PARP inhibitor to demonstrate patient benefit in a Phase III trial in this setting. ...

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COVID-19 border closures worry Americans who come to Canada to buy insulin

30 May 2020 - 'You're literally being denied the air that you need to breathe,' Travis Paulson says. ...

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Canada's new drug price rules pushed to next year

1 June 2020 - Canada's drug pricing agency said on Monday that new regulations aimed at lowering costs would come ...

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AbbVie submits regulatory applications to FDA and EMA for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis

1 June 2020 - Submissions supported by two Phase 3 studies in which Rinvoq demonstrated improved joint outcomes, physical function and ...

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Brilinta approved in the US to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease

1 June 2020 - New Brilinta indication expands treatment to high-risk coronary patients without a history of stroke or heart ...

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CytoDyn files request with FDA for priority review of BLA for first approval

1 June 2020 - If granted, the FDA is expected to take action on the Company’s BLA within six months. ...

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Lilly's Taltz (ixekizumab) is the first IL-17A antagonist to receive U.S. FDA approval for the treatment of non-radiographic axial spondyloarthritis

1 June 2020 - Taltz is now approved to treat patients across the full axSpA spectrum, including ankylosing spondylitis, also known ...

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Health economic assessment of Vimizim in mucopolysaccharidosis type IVA (Morquio A syndrome)

29 May 2020 - TLV has developed a health economic knowledge base for the regions of the drug Vimizim (elosulfase alfa) ...

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Zionexa USA and PETNET Solutions announce FDA approval of Cerianna (Fluoroestradiol F 18)

27 May 2020 - Zionexa USA and PETNET Solutions have announced that the FDA has approved Cerianna (fluoroestradiol F 18) injection ...

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U.S. FDA approves new paediatric formulation of Sirturo (bedaquiline) as part of combination therapy to treat children with pulmonary multidrug-resistant tuberculosis

27 May 2020 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. FDA has granted ...

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Orphazyme initiates rolling submission of new drug application for arimoclomol with US FDA in Niemann-Pick disease type C

29 May 2020 - EMA marketing authorisation application submission expected in H2 2020. ...

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CHMP issues positive opinion to extend Invokana (canagliflozin) indication to reflect improved renal outcomes in patients with diabetic kidney disease and type 2 diabetes

29 May 2020 - Positive opinion is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation ...

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Menlo Therapeutics receives FDA approval of Zilxi (minocycline) 1.5 % topical foam, the first topical minocycline treatment for rosacea

29 May 2020 - Zilxi now approved for inflammatory lesions of rosacea in adults. ...

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Boehringer Ingelheim receives positive CHMP opinion for a third nintedanib indication in pulmonary fibrosis

29 May 2020 - The opinion is for the treatment of adults with other chronic fibrosing interstitial lung diseases with a ...

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Takeda receives positive CHMP opinion for pre-filled syringe presentation of Takhzyro (lanadelumab) for use as a preventive treatment for hereditary angioedema attacks

29 May 2020 - Validation of type II variation will allow Takeda to commence launches in Europe later this year. ...

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