Blog
RSS FeedPosted by Michael Wonder on 27 Jan 2022
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...
Posted by Michael Wonder on 20 Jan 2022
Omeros confirms submission of response to FDA regarding the BLA for narsoplimab in the treatment of HSCT-TMA
19 January 2022 - Omeros Corporation today confirmed that earlier this month the company submitted to the U.S. FDA its response ...
Posted by Michael Wonder on 20 Jan 2022
Pathogenomix granted FDA breakthrough device designation
19 January 2022 - Patho-Seq uses next generation sequencing to rapidly identify bacteria from human samples during dangerous and life-threatening ...
Posted by Michael Wonder on 20 Jan 2022
Two anti-viral COVID-19 treatments approved
20 January 2022 - The Australian Government welcomes the Therapeutic Goods Administration’s provisional approval of the first oral treatments for COVID-19 ...
Posted by Michael Wonder on 20 Jan 2022
ChemoCentryx announces EU approval of Tavneos (avacopan) for the treatment of ANCA associated vasculitis
19 January 2022 - ChemoCentryx today announced that Tavneos (avacopan) has been approved within the European Union in combination with a ...
Posted by Michael Wonder on 20 Jan 2022
Celcuity receives FDA fast track designation for gedatolisib in HR positive, HER2 negative metastatic breast cancer
18 January 2022 - On track to finalise Phase 3 clinical trial design for gedatolisib with FDA feedback in first quarter. ...
Posted by Michael Wonder on 20 Jan 2022
TGA provisionally approves Novavax (Biocelect) COVID-19 vaccine Nuvaxovid
20 January 2022 - The Therapeutic Goods Administration has granted provisional approval to Biocelect (on behalf of Novavax) for its ...
Posted by Michael Wonder on 19 Jan 2022
Beyond survival: the US FDA confirms surrogate end points for patients with newly diagnosed acute myeloid leukaemia treated with intensive chemotherapy
10 January 2022 - The treatment of acute myeloid leukaemia has rapidly evolved over the past decade. ...
Posted by Michael Wonder on 19 Jan 2022
TGA provisionally approves two oral COVID-19 treatments, molnupiravir (Lagevrio) and nirmatrelvir and ritonavir (Paxlovid)
20 January 2022 - The TGA has granted provisional approval to two oral COVID-19 treatments: Paxlovid (nirmatrelvir and ritonavir, Pfizer) ...
Posted by Michael Wonder on 19 Jan 2022
Lieutenant General John Frewen says he expects TGA approval of Novavax vaccine is 'imminent'
19 January 2022 - The head of Australia's vaccine rollout expects one to two per cent of Australians who remain unvaccinated ...
Posted by Michael Wonder on 19 Jan 2022
Sensydia receives FDA breakthrough device designation for CPS non-invasive cardiac monitoring device
19 January 2022 - Sensydia today announced that its cardiac performance system has been granted breakthrough device designation by the United ...
Posted by Michael Wonder on 19 Jan 2022
UK’s NICE to launch sweeping changes to drug assessments to be faster, more agile
19 January 2022 - The health technology assessment body has been under pressure from drugmakers and patient groups for years to ...
Posted by Michael Wonder on 19 Jan 2022
FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC
19 January 2022 - Regulatory filing recently submitted in the European Union. ...
Posted by Michael Wonder on 19 Jan 2022
Levo Therapeutics receives complete response letter from FDA for its new drug application for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome
18 January 2022 - Levo Therapeutics announced today that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 19 Jan 2022
CANbridge Pharmaceuticals CAN108 new drug application for Alagille syndrome accepted by China’s National Medical Products Administration
17 January 2022 - Priority review expected to be granted. ...
Posted by Michael Wonder on 19 Jan 2022
Early benefit assessment for new drugs 2021: G-BA sets a record with 146 completed procedures
10 January 2022 - At the beginning of the year, the Federal Joint Committee (G-BA) took stock of its assessment of ...