Shionogi’s novel antibiotic, Fetcroja (cefiderocol), has been selected by UK’S NICE/NHSE&I as part of an antimicrobial subscription style reimbursement model

21 December 2020 - NICE and the National Health Service England and Improvement have recognised the potential of Shionogi’s innovative ...

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FDA approves paediatric indication for Xeomin (incobotulintoxinA) for the treatment of chronic sialorrhoea

21 December 2020 - Xeomin is the first and only neuromodulator approved in the U.S. to treat paediatric patients with chronic ...

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FDA approves treatment for Ebola virus

21 December 2020 - The U.S. FDA approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) ...

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Jazz Pharmaceuticals announces initiation of biologics license application submission for JZP-458 for the treatment of acute lymphoblastic leukaemia or lymphoblastic lymphoma

21 December 2020 - Application to be reviewed under FDA's Oncology Center of Excellence Real-Time Oncology Review pilot program. ...

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Price disclosure 2021 April cycle outcomes summary

21 December 2020 - The summary of price disclosure price reductions for the 2021 April Cycle has now been published. ...

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Vertex announces FDA approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for use in people with cystic fibrosis with certain rare mutations

21 December 2020 - More than 600 people with certain rare cystic fibrosis mutations are now eligible for Trikafta, Symdeko or ...

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European Commission approves Aimmune’s Palforzia as first-ever treatment for peanut allergy in the EU

21 December 2020 - Peanut allergy is one of the most common food allergies in Europe. ...

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Swissmedic approves Buvidal for the treatment of opioid dependence

18 December 2020 - Camurus announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ...

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PBS website updates for Stage 2 PBS process improvements

21 December 2020 - The PBS website has been updated to support implementation of Stage 2 PBS process improvements from ...

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Kiwis going into debt to pay for drugs other countries fund

21 December 2020 - An internal stoush at the drug-buying agency PHARMAC has blocked funding for a life-extending drug for bowel ...

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Oyster Point Pharma submits new drug application to the U.S. FDA for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease

18 December 2020 - The new drug application submission is based on efficacy and safety results from a comprehensive clinical trial ...

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PHARMAC to fund new diabetes medicines with amended Special Authority criteria

21 December 2020 - PHARMAC has approved funding for two new medicines with substantial health benefits for around 53,000 New Zealanders ...

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Health Canada approves expanded indication for Soliqua

18 December 2020 - New indication for Soliqua offers an alternative approach for Canadians living with type 2 diabetes requiring treatment ...

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Expanded PBS access to breakthrough medicine for lung cancer

20 December 2020 - A significant lung cancer treatment option that costs approximately $88,000 a year will soon be available for ...

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U.S. FDA approves supplemental new drug application for Takeda’s Iclusig (ponatinib) for adult patients with resistant or intolerant chronic phase CML

19 December 2020 - Approval based on data from the Phase 2 OPTIC trial, which evaluated response-based Iclusig dosing regimens in ...

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