Highlights from the May 25-28 CHMP meeting

29 May 2020 - Eight new medicines recommended for approval. ...

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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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Expanded PBS medicines listings to provide new treatment options for over 170,000 asthmatics, and new hope for blood cancer patients

1 June 2020 - Australians with asthma and multiple myeloma will have broader access to life changing medicines as a result ...

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New combination therapy now reimbursed for Australians living with incurable blood cancer

 1 June 2020 - New combination therapy now reimbursed for Australians living with incurable blood cancer. ...

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Pharmacist claiming of paracetamol 500 mg with codeine 30 mg tablet prescriptions from 1 June 2020

1 June 2020 - Commencing 1 June 2020, the Pharmaceutical Benefits Scheme listings for opioid medicines will change. Included in ...

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Nabriva Therapeutics receives positive EU CHMP opinion for Xenleta (lefamulin) for the treatment of community-acquired pneumonia

29 May 2020 - If approved, Xenleta has the potential to be a first-in-class pleuromutilin antibiotic for the intravenous and ...

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Schedule of Pharmaceutical Benefits - 1 June 2020

1 June 2020 - The June 2020 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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Johnson & Johnson receives positive CHMP opinion for Janssen’s investigational preventive Ebola vaccine regimen

29 May 2020 - The investigational Ebola vaccine regimen leverages Janssen’s established AdVac and PER.C6 technologies and Bavarian Nordic’s MVA-BN technology. ...

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Greater flexibility for Australians with severe asthma with reimbursement of at-home

1 June 2020 - Greater flexibility for Australians with severe asthma with reimbursement of at-home, self-administration delivery of Nucala (mepolizumab) ...

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CHMP recommends EU approval of Roche’s Rozlytrek for people with NTRK fusion-positive solid tumours and for people with ROS1-positive, advanced non-small cell lung cancer

29 May 2020 - Rozlytrek has shown durable responses across multiple tumour types, including cancer that has spread to the brain, ...

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Novartis Piqray receives positive CHMP opinion to treat HR+/HER2- advanced breast cancer with a PIK3CA mutation

29 May 2020 - Piqray (alpelisib) in combination with fulvestrant will become first and only targeted treatment for advanced breast ...

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