Top Democrats call for watchdog to review Trump Medicare drug cards

13 October 2020 - Top-ranking Democrats want an independent watchdog to expedite a review of the Trump administration's plans to ...

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Inventiva receives FDA breakthrough therapy designation for lead drug candidate lanifibranor in NASH

12 October 2020 - Inventiva today announced that the U.S. FDA has granted breakthrough therapy designation to lanifibranor, the Company’s lead ...

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Real world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug product

5 October 2020 - The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. ...

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Innova Therapeutics receives rare paediatric disease designation from the FDA for IVT-8086 for the treatment of osteosarcoma

24 September 2020 - Innova Therapeutics Inc., a biopharmaceutical company committed to developing innovative cancer therapies for patients who have inadequate ...

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Medicare wouldn’t cover costs of administering coronavirus vaccine approved under Emergency Use Authorisation

21 September 2020 - Trump administration officials are exploring options to quickly fix plan to make the vaccine free for all ...

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New early scientific advice service to support medicine registrations

22 September 2020 - The Therapeutic Goods Administration has launched a new initiative - the Early Scientific Advice service - ...

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CMS grants additional reimbursement for the Eluvia drug eluting vascular stent system

3 September 2020 - Boston Scientific announced that the U.S. Centers for Medicare and Medicaid Services granted a new technology add-on ...

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EMA agrees to review UCB's bimekizumab

18 August 2020 - Information about marketing authorisation application to EMA not yet disclosed by UCB. ...

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Medicare Part D plans rarely cover brand name drugs when generics are available

3 August 2020 - Study examines Medicare Part D coverage to quantify how often brand-name drugs are designated preferred over generics. ...

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Use of infliximab biosimilar in Medicare population is low but growing

7 July 2020 - Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the ...

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Abandoning list prices in Medicaid drug reimbursement did not affect spending

7 July 2020 - State fee-for-service Medicaid programs have traditionally based payments to pharmacies for drugs on a percentage of the ...

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CMS’s proposed Medicaid best price loophole for value based purchasing of drugs

6 July 2020 - For three decades, US pharmaceutical companies have agreed to sell their products to Medicaid programs at ...

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NICE's evaluations of medicines authorized by EMA with conditional marketing authorization or under exceptional circumstances

25 June 2020 - Products which received conditional marketing authorisation or authorisation in exceptional circumstances by European Medicines Agency up to ...

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Federal prosecutors allege Regeneron used a charity to pay kickbacks to Medicare patients

24 June 2020 - Federal officials on Wednesday alleged that Regeneron Pharmaceuticals donated tens of millions of dollars to a ...

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MHRA extends access to Santhera's DMD drug via the EAMS

23 June 2020 - The UK’s Medicines and Healthcare products Regulatory Agency has renewed for a further year the Early ...

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