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 ...

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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 ...

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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 ...

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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 ...

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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.  ...

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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 ...

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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 ...

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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 ...

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SMC - January 2021 decisions

18 January 2021 - The SMC, which advises on newly licensed medicines for use by NHSScotland, has today published advice ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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