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RSS FeedPosted 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 ...
Posted by Michael Wonder on 03 Sep 2020
FDA approves additional doses of Trulicity (dulaglutide) for the treatment of type 2 diabetes mellitus
3 September 2020 - AWARD-11 showed 3.0 mg and 4.5 mg doses led to additional blood sugar control; as a secondary ...
Posted by Michael Wonder on 03 Sep 2020
Tolak is included in the high-cost protection
2 September 2020 - Tolak, a topical treatment for adults with non-hyperkeratotic and non-hypertrophic actinic keratosis (Olsen grade I and II) ...
Posted by Michael Wonder on 03 Sep 2020
How Trump could use a rare regulatory manoeuvre to lower drug prices before Election Day, and how it could backfire
3 September 2020 - The final two months before a presidential election don’t typically feature much policymaking, and there are rules ...
Posted by Michael Wonder on 03 Sep 2020
Second Trump appointee out at FDA amid credibility concerns
2 September 2020 - A second Trump administration appointee has been ousted at the Food and Drug Administration after the agency’s ...
Posted by Michael Wonder on 03 Sep 2020
UK bladder cancer patients get early access to Bavencio
3 September 2020 - Merck and Pfizer’s Bavencio (avelumab) is now available under the UK's Early Access to Medicines Scheme ...
Posted by Michael Wonder on 03 Sep 2020
Janssen disappointed with second NICE no for Spravato
3 September 2020 - Janssen says it is disappointed with second draft guidance from the National Institute for Health and ...
Posted by Michael Wonder on 03 Sep 2020
U.K. MHRA grants meeting to CytoDyn to discuss fast track approval of leronlimab for COVID-19 patients
2 September 2020 - U.S. FDA schedules type A meeting with CytoDyn to discuss biologic license application filing for HIV. ...
Posted by Michael Wonder on 03 Sep 2020
The mother of three on her last chance to beat blood cancer
2 September 2020 - Deb Sims knows she’s on her last chance to beat the blood cancer that has dogged ...