Medicare lays out the bureaucracy it will need to negotiate drug prices

29 September 2022 - New documents outline how Medicare is planning to build out a sizeable new bureaucratic infrastructure to ...

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FDA grants accelerated approval to futibatinib for cholangiocarcinoma

30 September 2022 - Today, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho) for adult patients ...

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Biogen announced EMA filing acceptance of BIIB800, a biosimilar candidate referencing RoActemra (tocilizumab)

30 September 2022 - Biogen announced that the EMA has accepted the marketing authorisation application for BIIB800, a biosimilar candidate ...

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Schedule of Pharmaceutical Benefits - 1 October 2022

1 October 2022 - The October 2022 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...

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NICE review does not recommend routine funding for Duchenne muscular dystrophy gene therapy ataluren in draft guidance

30 September 2022 - NICE has today published draft guidance for public consultation which does not recommend ataluren (Translarna, PTC Therapeutics) ...

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European Medicines Agency accepts Astellas’ marketing authorisation application for fezolinetant

30 September 2022 - If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor ...

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Why non-funding of cystic fibrosis treatment is unacceptable

30 September 2022 - Edward Lee has self-funded the Trikafta drug that alleviates the symptoms of his cystic fibrosis since 2019. ...

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FDA approves new treatment option for patients with ALS

29 September 2022 - The US FDA today approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis, commonly ...

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Catalyst Pharmaceuticals announces FDA approval of supplemental new drug application for Firdapse expanding patient population to include paediatric patients

29 September 2022 - Firdapse is now a treatment option for all LEMS patients 6 years of age and older in ...

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Fore Biotherapeutics announces fast track designation granted by FDA to FORE8394 for the treatment of cancers harbouring BRAF class 1 and class 2 alterations

28 September 2022 - FORE8934 currently being evaluated in Phase 1/2a trial for the treatment of advanced solid and CNS tumours ...

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Dupixent (dupilumab) approved by FDA as the first and only treatment indicated for prurigo nodularis

28 September 2022 - Dupixent significantly reduced itch and skin lesions compared to placebo in direct-to-Phase 3 program consisting of two ...

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Citius Pharmaceuticals submits biologics license application to the US Food and Drug Administration for denileukin diftitox for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma

28 September 2022 - Citius Pharmaceuticals today announced that the Company has submitted a biologics license application to the US FDA ...

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Toray receives approval from China’s NMPA for Careload to treat pulmonary arterial hypertension

28 September 2022 - Toray Industries announced today that it has received approval from China’s NMPA for Careload tablets to treat ...

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News “hyperbole” in Government media releases on new drugs can undermine confidence in NHS, says editor

28 September 2022 - Phrases such as “cutting edge,” “game changing,” and “ground breaking” have no place in the description ...

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Celltrion USA receives US FDA approval for its oncology biosimilar Vegzelma (bevacizumab-adcd) for the treatment of six types of cancer

28 September 2022 - The approval is based on totality of evidence with no clinically meaningful differences in efficacy or safety ...

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