Blog
RSS FeedPosted by Michael Wonder on 07 Sep 2020
SMC recommends Merck's Keytruda for another two indications
7 September 2020 - Pembrolizumab (Keytruda) has been accepted for the treatment of patients with head and neck squamous cell carcinoma ...
Posted by Michael Wonder on 07 Sep 2020
SMC accepts Spravato (esketamine) nasal spray for use in adults with treatment-resistant major depressive disorder in Scotland
7 September 2020 - SMC acceptance comes less than a week after second rejection by NICE. ...
Posted by Michael Wonder on 07 Sep 2020
SMC - September 2020 decisions
7 September 2020 - The SMC has today published advice accepting fourteen new medicines. ...
Posted by Michael Wonder on 06 Sep 2020
Venclyxto in combination with obinutuzumab is included in the high-cost protection with limitation
28 August 2020 - Venclyxto (venetoclax) is already included in the high-cost protection with limited subsidy. ...
Posted by Michael Wonder on 06 Sep 2020
NICE not supportive of encorafenib for metastatic colorectal cancer
4 September 2020 - NICE has responded to the request of the Department of Health and Social Care to produce ...
Posted by Michael Wonder on 05 Sep 2020
Real world evidence to support payer/HTA decisions about highly innovative technologies in the EU—actions for stakeholders
3 September 2020 - There are divergent views on the potential of real world data to inform decisions made by regulators, ...
Posted by Michael Wonder on 05 Sep 2020
Hamilton 22 year old given compassionate access to $80k cancer treatment unfunded by PHARMAC
5 September 2020 - The future is a difficult concept for Ryan Grieve, whose terminal cancer diagnosis was hopefully prolonged ...
Posted by Michael Wonder on 05 Sep 2020
Biocon, Mylan launch Semglee and seek biosimilar, interchangeable status
31 August 2020 - For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to ...
Posted by Michael Wonder on 05 Sep 2020
International reference pricing: discounts down under far surpass U.S. drug price concessions
1 September 2020 - At 30,000 feet, the view of Australia’s healthcare system does not look too different from our own ...
Posted by Michael Wonder on 05 Sep 2020
Seniors suffer the most from antiquated FDA approval process
4 September 2020 - Americans have been heartbroken as report after report shines a light on the COVID-19 pandemic sweeping ...
Posted by Michael Wonder on 05 Sep 2020
Genentech announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion positive non-small cell lung cancer
4 September 2020 - Gavreto is a once-daily, oral precision therapy that selectively inhibits RET-altered cancers. ...
Posted by Michael Wonder on 05 Sep 2020
Ascendis Pharma announces U.S. FDA accepts biologics license application for TransCon hGH for paediatric growth hormone deficiency
4 September 2020 - Prescription Drug User Fee Act target action date of 25 June 2021. ...
Posted by Michael Wonder on 04 Sep 2020
PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids
4 September 2020 - A review by EMA’s safety committee has confirmed that 5 mg ulipristal acetate (Esmya and generic ...
Posted by Michael Wonder on 04 Sep 2020
Innovent announces NMPA granted marketing approval for Sulinno (adalimumab injection) in China
Innovent Biologics today announced that Sulinno (adalimumab injection), a recombinant human anti-TNF-α monoclonal antibody drug, has been officially approved by ...
Posted by Michael Wonder on 03 Sep 2020
Health Department moving TGA to new $60 million Canberra Airport campus
4 September 2020 - The Health Department will leave its ageing Symonston facility in 2022 for a new $60 million purpose ...