Blog
RSS FeedPosted by Michael Wonder on 01 Dec 2022
FDA approves first faecal microbiota product
30 November 2022 - Today, the US FDA approved Rebyota, the first faecal microbiota product approved by the agency. ...
Posted by Michael Wonder on 29 Nov 2022
Mepolizumab for the treatment of patients with severe hypereosinophilic syndrome
29 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 29 Nov 2022
Mepolizumab for the treatment of patients with eosinophilic granulomatosis with polyangiitis
29 November 2022 - The Department of Health and Social Care has asked NICE to produce guidance on the use of ...
Posted by Michael Wonder on 29 Nov 2022
Health Canada has approved Sotyku (deucravacitinib tablets), an oral treatment for adults with moderate to severe plaque psoriasis
28 November 2022 - Sotyktu is the first and only approved TYK2 inhibitor in Canada and represents an important milestone ...
Posted by Michael Wonder on 29 Nov 2022
FDA looks to modelling and simulation tools to streamline product reviews
28 November 2022 - The US FDA recently published a report on how it uses modelling and simulation, highlighting the untapped ...
Posted by Michael Wonder on 28 Nov 2022
Type 2 diabetes drug shortage: Victoria’s Ozempic, Trulicity supplies limited until March
28 November 2022 - Type 2 diabetes sufferers are spending hours driving around the suburbs begging pharmacists for a drug that’s ...
Posted by Michael Wonder on 28 Nov 2022
Croma Australia, a subsidiary of Hugel Aesthetics, receives TGA approval in Australia for Letybo (letibotulinumtoxinA) for the treatment of glabellar lines
28 November 2022 - Approval is supported by positive results from three completed Phase 3 trials that enrolled more than 1000 ...
Posted by Michael Wonder on 28 Nov 2022
Ferinject approved in China for the treatment of iron deficiency in adult patients
28 November 2022 - China has the world’s largest iron deficiency anaemia population with estimated prevalence of 15%. ...
Posted by Michael Wonder on 28 Nov 2022
'Reimbursement criteria for CGRP inhibiting migraine drugs not realistic'
28 November 2022 - The CGRP (calcitonin gene-related peptide) inhibitors, developed to prevent adult migraines, have recently been registered on ...
Posted by Michael Wonder on 28 Nov 2022
Lantheus announces the approval of Definity (perflutren lipid microsphere) by China’s NMPA
28 November 2022 - Definity is the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms. ...
Posted by Michael Wonder on 28 Nov 2022
Bayer’s Nubeqa receives MHRA approval to treat metastatic prostate cancer
28 November 2022 - The treatment will be made available immediately through an early access deal with NHS England. ...
Posted by Michael Wonder on 28 Nov 2022
Joint statement: NICE and SMC/HIS collaboration
25 November 2022 - NICE and SMC/HIS collaboration on the health technology appraisal of tixagevimab–cilgavimab (Evusheld) for preventing COVID-19. ...
Posted by Michael Wonder on 28 Nov 2022
NICE recommends Rinvoq (upadacitinib) as treatment option for moderately to severely active ulcerative colitis in adults
25 November 2022 - Publication of positive Final Draft Guidance from NICE is supported by data from three clinical studies that ...
Posted by Michael Wonder on 28 Nov 2022
Sarepta Therapeutics announces that US FDA has accepted for filing and granted priority review for the biologics license application for SRP-9001, Sarepta’s gene therapy for the treatment of ambulant individuals with Duchenne muscular dystrophy
28 November 2022 - Regulatory action date of 29 May 2023. ...
Posted by Michael Wonder on 28 Nov 2022
Kintara Therapeutics granted fast track designation from FDA for REM-001 for cutaneous metastatic breast cancer
28 November 2022 - Kintara Therapeutics today announced that the US FDA has granted fast track designation to Kintara's REM-001 ...
Posted by Michael Wonder on 28 Nov 2022
An open letter to doctors from the TGA
28 November 2022 - The TGA welcomes feedback and is committed to continuously improving processes and communications. ...