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RSS FeedPosted by Michael Wonder on 30 Sep 2022
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 ...
Posted by Michael Wonder on 30 Sep 2022
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 ...
Posted by Michael Wonder on 30 Sep 2022
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 ...
Posted by Michael Wonder on 30 Sep 2022
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. ...
Posted by Michael Wonder on 30 Sep 2022
NICE review does not recommend routine funding for Duchenne muscular dystrophy gene therapy ataluren in draft guidance
30 September 2022 - NICE has today published draft guidance for public consultation which does not recommend ataluren (Translarna, PTC Therapeutics) ...
Posted by Michael Wonder on 30 Sep 2022
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 ...
Posted by Michael Wonder on 29 Sep 2022
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. ...
Posted by Michael Wonder on 29 Sep 2022
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 ...
Posted by Michael Wonder on 29 Sep 2022
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 ...
Posted by Michael Wonder on 29 Sep 2022
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 ...
Posted by Michael Wonder on 28 Sep 2022
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 ...
Posted by Michael Wonder on 28 Sep 2022
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 ...
Posted by Michael Wonder on 28 Sep 2022
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 ...
Posted by Michael Wonder on 28 Sep 2022
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 ...
Posted by Michael Wonder on 28 Sep 2022
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 ...