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RSS FeedPosted by Michael Wonder on 18 Jul 2022
Everest Medicines announces European Commission grants approval of Kinpeygo for adults with primary IgA nephropathy to our partner Calliditas Therapeutics
17 July 2022 - Kinpeygo (developed under the name Nefecon) is the first and only EMA approved treatment for IgAN. ...
Posted by Michael Wonder on 18 Jul 2022
Relief Therapeutics announces that its collaboration partner has resubmitted the ACER-001 (sodium phenylbutyrate) new drug application to the FDA for the treatment of urea cycle disorders
18 July 2022 - Relief Therapeutics today announced that its collaboration partner, Acer Therapeutics for ACER-001 (sodium phenylbutyrate) for oral ...
Posted by Michael Wonder on 18 Jul 2022
AbbVie submits marketing authorisation application to EMA for atogepant for the preventive treatment of migraine
18 July 2022 - The submission is based on two pivotal Phase 3 studies evaluating atogepant in adult patients with episodic ...
Posted by Michael Wonder on 16 Jul 2022
Polpharma Biologics announces EMA acceptance of marketing authorisation application for proposed biosimilar natalizumab
14 July 2022 - Polpharma Biologics announced today that the EMA has accepted the first-ever marketing authorisation application for biosimilar natalizumab, ...
Posted by Michael Wonder on 15 Jul 2022
Health Canada authorises use of Moderna COVID-19 vaccine in children 6 months to 5 years of age
14 July 2022 - Today, Health Canada authorised the use of the Moderna Spikevax COVID-19 vaccine in children 6 months to ...
Posted by Michael Wonder on 15 Jul 2022
TGA approves Grifols' Xembify
15 July 2022 - Xembify is yet another presentation of human immunoglobulin. ...
Posted by Michael Wonder on 14 Jul 2022
Marinus Pharmaceuticals sells rare paediatric disease priority review voucher for $110 million
14 July 2022 - Marinus Pharmaceuticals today announced that it has entered into a definitive agreement to sell its rare ...
Posted by Michael Wonder on 14 Jul 2022
FDA clears DyAnsys neurostimulation device first relief to treat diabetic neuropathic pain
14 July 2022 - First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the US FDA for ...
Posted by Michael Wonder on 14 Jul 2022
FDA approves crizotinib for ALK positive inflammatory myofibroblastic tumour
14 July 2022 - On 14 July 2022, the FDA approved crizotinib (Xalkori, Pfizer) for adult and paediatric patients one ...
Posted by Michael Wonder on 14 Jul 2022
COVID-19 vaccine safety report (14 July 2022)
14 July 2022 - To 10 July 2022, the TGA has received 609 reports which have been assessed as likely to ...
Posted by Michael Wonder on 14 Jul 2022
BeiGene provides regulatory update on the U.S. biologics license application for PD-1 inhibitor tislelizumab in second-line oesophageal squamous cell carcinoma
14 July 2022 - Due to COVID travel restrictions, inspections could not be completed during review period. ...
Posted by Michael Wonder on 14 Jul 2022
FDA grants Alpheus Medical orphan drug and fast track designations for novel sonodynamic therapy for brain cancer
13 July 2022 - The company is currently enrolling patients in a multicentre Phase 1 clinical trial for the treatment ...
Posted by Michael Wonder on 13 Jul 2022
FDA authorises emergency use of Novavax COVID-19 vaccine, adjuvanted
13 July 2022 - Today, the U.S. FDA issued an emergency use authorisation for the Novavax COVID-19 vaccine, adjuvanted for the ...
Posted by Michael Wonder on 13 Jul 2022
Accelerating pooled licensing of medicines to enhance global production and equitable access
8 July 2022 - From October to November, 2021, the pharmaceutical firms Merck and Pfizer licensed their new COVID-19 oral antiviral ...
Posted by Michael Wonder on 13 Jul 2022
Ancora Heart receives breakthrough device designation from FDA for the AccuCinch ventricular restoration system
12 July 2022 - Designation allows for expedited review of transcatheter therapy designed to improve left ventricular structure and function ...