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STAT+: Medicare has a new plan to address drug shortages — but it could backfire

STAT

WASHINGTON — Medicare has a new proposal to pay hospitals more to stockpile essential drugs — an idea that comes as doctors report running low on critical chemotherapies and other drugs. But Medicare has its own new idea: paying hospitals to create a “buffer stock” of 86 medicines that HHS deems critical.

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Blue Note leukaemia DTx gets FDA breakthrough tag

pharmaphorum

A prescription digital therapeutic (DTx) for leukaemia patients developed by Blue Note Therapeutics has been awarded breakthrough device status by the FDA. Last year, Biofourmis said its heart failure tool BiovitalsHF was the first DTx to be awarded breakthrough status by the FDA.

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Cancer treatment times set to reduce as SC atezolizumab gains MHRA approval

Hospital Pharmacy Europe

However, where patients are receiving intravenous chemotherapy in combination with atezolizumab, they may remain on the transfusion. Evaluations by the US Food and Drug Administration (FDA) and other health authorities globally are also ongoing.

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Trial of Jazz’ cannabis drug in glioblastoma will start next year

pharmaphorum

The three-year phase 2 trial will be carried out by researchers at Leeds University led by professor of clinical oncology and neuro-oncology Susan Short, and see if adding Sativex (nabiximols) to standard chemotherapy for recurrent glioblastoma can extend survival. Jazz acquired rights to Sativex when it completed its $7.2

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FDA to decide on Roche’s lymphoma drug Lunsumio before year-end

pharmaphorum

The FDA has granted a priority review to Roche’s T-cell engager Lunsumio as a treatment for follicular lymphoma (FL), setting up a decision on the drug by 29 December. The post FDA to decide on Roche’s lymphoma drug Lunsumio before year-end appeared first on.

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CHMP meeting highlights: April 2024

European Pharmaceutical Review

Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B. If approved, fruquintinib could provide a new oral, chemotherapy-free option as the first and only selective inhibitor of all three vascular endothelial growth factor receptors (VEGFR) receptors approved in the EU for this disease, according to Takeda.

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EMA grants mitazalimab orphan drug designation for pancreatic cancer

Hospital Pharmacy Europe

Targeting CD40 with mitazalimab has the potential to augment responses to chemotherapy. The EMA orphan drug designation follows a similar approval by the FDA in May 2023. The post EMA grants mitazalimab orphan drug designation for pancreatic cancer appeared first on Hospital Pharmacy Europe. A median duration of response of 8.7