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RSS FeedPosted by Michael Wonder on 19 Jan 2021
NHS patients to benefit from first full access deal in Europe for new CAR-T therapy recommended by NICE
19 January 2021 - NICE has agreed a managed access agreement, via the Cancer Drugs Fund with manufacturer Kite, so more ...
Posted by Michael Wonder on 19 Jan 2021
Occlutech's atrial flow regulator receives U.S. FDA breakthrough device designation for heart failure
19 January 2021 - Occlutech announced today that the U.S FDA has granted the Company a breakthrough revice designation for its ...
Posted by Michael Wonder on 19 Jan 2021
Metacrine announces FDA fast track designation for MET642 as a treatment of NASH
19 January 2021 - Metacrine today announced that the U.S. FDA has granted fast track designation to MET642, the company’s second ...
Posted by Michael Wonder on 19 Jan 2021
Regulators OK Yuhan's Leclaza as 31st novel drug
18 January 2020 - Yuhan said Monday that it has received sales approval for Leclaza (lazertinib), a drug targeting epidermal ...
Posted by Michael Wonder on 19 Jan 2021
The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines
13 January 2021 - Few medicines are awaited as eagerly as COVID-19 vaccines. ...
Posted by Michael Wonder on 19 Jan 2021
Tessa Therapeutics receives PRIME designation from European Medicines Agency for CD30 CAR-T therapy
18 January 2021 - Tessa Therapeutics today announced that the EMA has granted PRiority MEdicines (PRIME) designation to the company's lead ...
Posted by Michael Wonder on 18 Jan 2021
Norway finds no direct link between elderly deaths and vaccine
19 January 2021 - Health authorities in Norway say there's no evidence of a direct link between the recent string ...
Posted by Michael Wonder on 18 Jan 2021
Double vaccine rollout in plan to defeat COVID-19
19 January 2021 - The nation’s top scientific advisers could recommend the rollout of a second round of immunisations to ...
Posted by Michael Wonder on 18 Jan 2021
SMC - January 2021 decisions
18 January 2021 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...
Posted by Michael Wonder on 18 Jan 2021
HHS regulations with enduring impact on pricing and reimbursement of medical services and technologies
17 January 2021 - The Trump Administration’s grandiose healthcare plans didn’t come to fruition, like the promised repeal and replace of ...
Posted by Michael Wonder on 18 Jan 2021
Changes to Medicare Advantage and Part D will provide better coverage, more access and improved transparency for Medicare beneficiaries
15 January 2021 - Today, the CMS issued a final rule that further advances the agency’s efforts to strengthen and modernise ...
Posted by Michael Wonder on 18 Jan 2021
FDA sped progress for most of 2020's novel drugs
14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process ...
Posted by Michael Wonder on 18 Jan 2021
ICER issues correction to final evidence report on new therapies for bladder cancer
15 January 2021 - After correcting an input to the cost-effectiveness model, ICER’s health-benchmark price benchmark range for nadofaragene firadenovec has ...
Posted by Michael Wonder on 18 Jan 2021
Norwegian investigation of COVID-19 vaccination risks for elderly, very frail patients
17 January 2021 - In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals ...
Posted by Michael Wonder on 18 Jan 2021
How NZ is preparing for the biggest vaccine roll-out in history
17 January 2021 - “When will we get a vaccine for COVID-19?” It has been the question on everyone’s lips for ...